Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 26, 2028 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody |
Actemra (; Injection) (; Intravenous) tocilizumab
NDA Applicant: Genentech, Inc. BLA No.: 125276 Prod. No.: 002 Rx (200MG/10ML (20MG/ML)); 003 Rx (400MG/20ML (20MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332289 Method of purifying protein Claim Types: Process Pat. Sub. Date(s): None | Aug 4, 2023 | |
| Pat. No. 7521052 Methods for treating interleukin-6 related diseases Claim Types: Method of use Pat. Sub. Date(s): None | Apr 28, 2024 | |
| Pat. No. 8398980 Subtypes of humanized antibody against interleuken-6 receptor Claim Types: Compound; Composition Pat. Sub. Date(s): None | Sep 27, 2026 | |
| Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 9, 2030 | |
| Pat. No. 8568720 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None | Nov 5, 2029 | |
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 9, 2027 | |
| Pat. No. 8580264 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None | Nov 8, 2030 | |
| Pat. No. 8617550 Treatment of vasculitis with IL-6 antagonist Claim Types: Method of use Pat. Sub. Date(s): None | Sep 11, 2025 | |
| Pat. No. 8709409 Method for treating rheumatoid arthritis by administering an anti-IL-6 antibody and methotrexate Claim Types: Method of use Pat. Sub. Date(s): None | Jun 22, 2024 | |
| Pat. No. 8734800 Subtypes of humanized antibody against interleukin-6 receptor Claim Types: Method of use Pat. Sub. Date(s): None | Mar 24, 2025 | |
| Pat. No. 9539263 Subcutaneously administered anti-IL-6 receptor antibody for treatment of systemic sclerosis Claim Types: Method of use Pat. Sub. Date(s): None | Nov 8, 2030 | |
| Pat. No. 9630988 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None | Jun 13, 2032 | |
| Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Jan 9, 2030 | |
| Pat. No. 9750752 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Method of use Pat. Sub. Date(s): None | Sep 1, 2031 | |
| Pat. No. 9902777 Methods for producing subtypes of humanized antibody against interleukin-6 receptor Claim Types: Process Pat. Sub. Date(s): None | May 28, 2025 | |
| Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10231981 Subcutaneously administered anti-IL-6 receptor antibody for treatment of juvenile idiopathic arthritis Claim Types: Method of use Pat. Sub. Date(s): None | Nov 19, 2030 | |
| Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jul 31, 2035 | |
| Pat. No. 10501769 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 10590164 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration Claim Types: Process Pat. Sub. Date(s): None | Mar 19, 2032 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2030 | |
| Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10744201 Method for treating rheumatoid arthritis with a human IL-6 receptor antibody and methotrexate Claim Types: Method of improving a treatment Pat. Sub. Date(s): None | Apr 28, 2024 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2033 | |
| Pat. No. 10874677 Subcutaneously administered anti-IL-6 receptor antibody Claim Types: Device Pat. Sub. Date(s): None | Mar 4, 2031 | |
| Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 11, 2029 | |
| Pat. No. 11008394 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Pat. No. 11021728 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 9, 2027 | |
| Pat. No. 11136375 Method for production of antibody Claim Types: Process Pat. Sub. Date(s): None | Oct 14, 2028 | |
| Pat. No. 11136610 Method for the production of a glycosylated immunoglobulin Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11359026 High concentration antibody-containing liquid formulation Claim Types: Process Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Pat. No. 11377678 Method for the production of a glycosylated immunoglobulin Claim Types: Process Pat. Sub. Date(s): None | Oct 25, 2030 | |
| Pat. No. 11584798 High concentration antibody-containing liquid formulation Claim Types: Formulation Pat. Sub. Date(s): None | Dec 26, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2024 | Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 4, 2028 | Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease |
Actemra (Injection) (Subcutaneous) tocilizumab
NDA Applicant: Genentech, Inc. BLA No.: 125472 Prod. No.: 001 Rx (162MG/0.9ML); 002 Rx (162MG/0.9ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan Designation: Treatment of pediatric patients (age 16 years and younger) with polyarticular-course juvenile idiopathic arthritis Approved Labeled Indication: ACTEMRA (tocilizumab) for subcutaneous injection is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older Exclusivity Protected Indication: Treatment of active polyarticular juvenile idiopathic arthritis in patients 2 through 16 years of age. |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 30, 2024 | Orphan Designation: Treatment of chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome Approved Labeled Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older Exclusivity Protected Indication: Treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and pediatric patients 2 years of age and older |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 4, 2028 | Orphan Designation: Treatment of systemic sclerosis Approved Labeled Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease Exclusivity Protected Indication: slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease |
Acthrel (For Injection) (Intravenous) corticorelin ovine triflutate
NDA Applicant: Ferring Pharmaceuticals Inc. BLA No.: 020162 Prod. No.: 001 Disc (100MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 23, 2003 | Orphan Designation: For use in differentiating pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushings syndrome. Approved Labeled Indication: To differentiate between pituitary and ectopic production of ACTH in patients with ACTH-dependent Cushing's syndrome. |
Actimmune (Injection) (Subcutaneous) interferon gamma-1b
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 103836 Prod. No.: 001 Rx (100MCG(2MILLION INTERNATIONAL UNITS)/0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 20, 1997 | Orphan Designation: Treatment of chronic granulomatous disease. |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 10, 2007 | Orphan Designation: Delaying time to disease progression in patients with severe, malignant osteopetrosis. Approved Labeled Indication: Delaying time to disease progression in patients with severe, malignant osteopetrosis. |
Adagen (Injection) (Intramuscular) pegademase bovine
NDA Applicant: Leadiant Biosciences, Inc BLA No.: 019818 Prod. No.: 001 Disc (375UNITS/1.5ML (250UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 21, 1997 | Orphan Designation: For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency. |
Adakveo (Injection) (Intravenous) crizanlizumab-tmca
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 761128 Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 15, 2026 | Orphan Designation: Treatment of sickle cell disease Approved Labeled Indication: ADAKVEO is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. Exclusivity Protected Indication: Indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. |
Adcetris (For Injection) (Intravenous) brentuximab vedotin
NDA Applicant: Seagen Inc. BLA No.: 125388 Prod. No.: 001 Rx (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11505593 Anti-VEGF protein compositions and methods for producing the same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2022 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of mycosis fungoides Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 20, 2025 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2025 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 10, 2029 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide Exclusivity Protected Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) |
Adstiladrin (For Suspension) (Intravesical) nadofaragene firadenovec-vncg
NDA Applicant: Ferring Pharmaceuticals A/S BLA No.: 125700 Prod. No.: 001 Disc (3x10^11 viral particles (vp)/mL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Dec 16, 2034 |
Aldurazyme (Injection) (Intravenous) laronidase
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125058 Prod. No.: 001 Rx (2.9MG/5ML (0.58MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 30, 2010 | Orphan Designation: Treatment of patients with mucopolysaccharidosis-I. Approved Labeled Indication: Treatment for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms |
Alphanate (For Injection) (Intravenous) Antihemophilic Factor/von Willebrand Factor Complex (Human)
NDA Applicant: Grifols Biologicals LLC BLA No.: 102475 Prod. No.: 001 Rx (250IU); 002 Rx (1000IU); 003 Rx (1500IU); 004 Rx (500IU); 005 Rx (2000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 31, 2014 | Orphan Designation: Treatment of von Willebrand's disease Approved Labeled Indication: For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery |
Alphanine, Alphanine Hp, Alphanine Sd (Injection) (Intravenous) Coagulation Factor IX (Human)
NDA Applicant: Grifols Biologicals LLC BLA No.: 103249 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 004 Rx (1500IU) BLA No.: 103249 Prod. No.: 003 Disc (250IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 31, 1997 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Alprolix (For Injection) (Intravenous) Coagulation Factor IX (Recombinant), Fc Fusion Protein
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125444 Prod. No.: 001 Rx (500IU); 002 Rx (2000IU); 003 Rx (1000IU); 004 Rx (3000IU); 005 Rx (250IU); 006 Rx (4000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 28, 2021 | Orphan Designation: Control and prevention of hemorrhagic episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease) Approved Labeled Indication: Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Exclusivity Protected Indication: Adults and children with Hemophilia B for control and prevention of bleeding episodes, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. |
ALTUVIIIO (For Injection) (Intravenous) antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
NDA Applicant: Bioverativ Therapeutics, Inc. BLA No.: 125771 Prod. No.: 001 Rx (250IU); 002 Rx (500IU); 003 Rx (750IU); 004 Rx (1000IU); 005 Rx (2000IU); 006 Rx (3000IU); 007 Rx (4000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 22, 2030 | Orphan Designation: Treatment of hemophilia A Approved Labeled Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding Exclusivity Protected Indication: in adults and children with hemophilia A (congenital factor VIII deficiency) for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding |
Anascorp (For Injection) (Intravenous) Centruroides (Scorpion) Immune F(ab')2 (Equine) Injection
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT) BLA No.: 125335 Prod. No.: 001 Rx (>/=150 LD50 NEUTRALIZING UNITS)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 4, 2018 | Orphan Designation: Treatment of scorpion envenomations requiring medical attention. Approved Labeled Indication: Treatment of clinical signs of scorpion envenomation |
Anavip (For Injection) (Intravenous) Crotalidae Immune F(ab')2 (Equine)
NDA Applicant: Rare Disease Therapeutics, Inc. (RDT) BLA No.: 125488 Prod. No.: 001 Rx (MINIMUM 780 BOTHROPS ASPER, 790 C.SIMUS, 244 C.ADAMANTEUS, 147 C.ATROX, 185 C.SCUTULATUS, 28 AGKISTRODON CONTORTRIX, 61 A.PISCIVORUS LD50 NEUTRALIZING UNITS/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 6, 2022 | Orphan Designation: Treatment of envenomation by Crotaline snakes Approved Labeled Indication: Management of adult and pediatric patients with North American rattlesnake envenomation Exclusivity Protected Indication: Management of adult and pediatric patients with North American rattlesnake envenomation |
Andexxa (Injection) (Intravenous) Coagulation Factor Xa (Recombinant), Inactivated-zhzo
NDA Applicant: AstraZeneca AB BLA No.: 125586 Prod. No.: 001 Rx (100MG); 002 Rx (200MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 3, 2025 | Orphan Designation: For reversing the anticoagulant effect of direct or indirect factor Xa inhibitors in patients experiencing a serious uncontrolled bleeding event or who require urgent or emergent surgery Approved Labeled Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding Exclusivity Protected Indication: Coagulation factor Xa (recombinant), inactivated-zhzo is indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding |
Anthim (Injection) (Intravenous) obiltoxaximab
NDA Applicant: Elusys Therapeutics, Inc. BLA No.: 125509 Prod. No.: 001 Rx (600MG/6ML (100MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2023 | Orphan Designation: Treatment of exposure to B. anthracis spores Approved Labeled Indication: Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs and for prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or are not appropriate. Exclusivity Protected Indication: 1) Treatment of adult and pediatric patients with inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and (2) for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. |
Anthrasil (Injection) (Intravenous) Anthrax Immune Globulin Intravenous (Human)
NDA Applicant: Emergent BioSolutions Canada Inc. BLA No.: 125562 Prod. No.: 001 Rx (>=60 U)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 24, 2022 | Orphan Designation: Treatment of inhalational anthrax Approved Labeled Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs Exclusivity Protected Indication: Treatment of inhalational anthrax in adult and pediatric patients in combination with appropriate antibacterial drugs |
Arcalyst (For Injection) (Subcutaneous) rilonacept
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd. BLA No.: 125249 Prod. No.: 001 Rx (220MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 27, 2015 | Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2028 | Orphan Designation: Treatment of pericarditis Approved Labeled Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older Exclusivity Protected Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older |
Arexvy (For Injection) (Intramuscular) Respiratory Syncytial Virus Vaccine, Adjuvanted
NDA Applicant: GlaxoSmithKline Biologicals BLA No.: 125775 Prod. No.: 001 Rx (120UG/.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | May 3, 2035 |
Arzerra (Injection) (Intravenous) ofatumumab
NDA Applicant: Novartis Pharmaceuticals Corporation BLA No.: 125326 Prod. No.: 001 Disc (100MG/5ML); 002 Disc (1,000MG/50ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 26, 2016 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2021 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate. Exclusivity Protected Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate. |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 19, 2023 | Orphan Designation: Treatment of chronic lymphocytic leukemia Approved Labeled Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. Exclusivity Protected Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. |
Asparlas (Injection) (Intravenous) calaspargase pegol-mknl
NDA Applicant: Servier Pharmaceuticals LLC BLA No.: 761102 Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 1, 2001 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Atryn (For Injection) (Intravenous) Antithrombin (Recombinant)
NDA Applicant: rEVO Biologics, Inc. BLA No.: 125284 Prod. No.: 001 Disc (1750IU); 002 Disc (525IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 6, 2016 | Orphan Designation: Treatment of congenital antithrombin deficiency to prevent the occurrence of serious, potentially life-threatening venous thromboembolisms which may develop as a result of surgical or obstetrical procedures Approved Labeled Indication: Prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients. |
Autoplex, Feiba Nf, Feiba Vh (For Injection) (Intravenous) Anti-Inhibitor Coagulant Complex
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 101447 Prod. No.: 003 Rx (1000U); 004 Rx (500U); 005 Rx (2500U) BLA No.: 101447 Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 16, 2020 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Avastin (Injection) (Intravenous) bevacizumab
NDA Applicant: Genentech, Inc. BLA No.: 125085 Prod. No.: 001 Rx (100MG/4ML (25MG/ML)); 002 Rx (400MG/16ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7485704 Reducing protein A leaching during protein A affinity chromatography Claim Types: Process Pat. Sub. Date(s): None | Mar 8, 2025 | |
| Pat. No. 8460895 Method for producing recombinant proteins with a constant content of pCO.sub.2 in the medium Claim Types: Process Pat. Sub. Date(s): None | Mar 11, 2029 | |
| Pat. No. 8512983 Production of proteins in glutamine-free cell culture media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 4, 2031 | |
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 9441035 Cell culture media and methods of antibody production Claim Types: Process Pat. Sub. Date(s): None | Apr 23, 2034 | |
| Pat. No. 9487809 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Process Pat. Sub. Date(s): None | Jan 14, 2032 | |
| Pat. No. 9714293 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 6, 2030 | |
| Pat. No. 9795672 Treatment with anti-VEGF antibodies Claim Types: Method of use Pat. Sub. Date(s): None | May 28, 2024 | |
| Pat. No. 10011856 Decreasing lactate level and increasing polypeptide production by downregulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Cell culture Pat. Sub. Date(s): None | May 26, 2031 | |
| Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10208355 Method of treatment for glioblastoma by administering a VEGF antagonist Claim Types: Method of use Pat. Sub. Date(s): None | Jul 14, 2035 | |
| Pat. No. 10274466 Elucidation of ion exchange chromatography input optimization Claim Types: Analytical procedure Pat. Sub. Date(s): None | Jul 11, 2035 | |
| Pat. No. 10336983 Method for increasing the specific production rate of eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jul 31, 2035 | |
| Pat. No. 10513697 CO.sub.2 profile cultivation Claim Types: Process Pat. Sub. Date(s): None | Sep 17, 2032 | |
| Pat. No. 10662237 Method to improve virus filtration capacity Claim Types: Process Pat. Sub. Date(s): None | May 26, 2031 | |
| Pat. No. 10676710 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10704071 Decreasing lactate level and increasing polypeptide production by down regulating the expression of lactate dehydrogenase and pyruvate dehydrogenase kinase Claim Types: Vector Pat. Sub. Date(s): None | Aug 18, 2031 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10906934 Protein purification methods Claim Types: Process Pat. Sub. Date(s): None | Oct 12, 2033 | |
| Pat. No. 10906986 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 10982003 Production of proteins in glutamine-free cell culture media Claim Types: Process Pat. Sub. Date(s): None | Aug 6, 2030 | |
| Pat. No. 11078294 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 2016 | Orphan Designation: Treatment of malignant glioma Approved Labeled Indication: Treatment of glioblastoma with progressive disease following prior therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 31, 2016 | Orphan Designation: Treatment of renal cell carcinoma Approved Labeled Indication: Treatment of renal cell carcinoma in combination with interferon alfa |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian cancer who have received no more than 2 prior chemotherapy regimens. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent primary peritoneal cancer who received no more than 2 prior chemotherapy regimens |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2021 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than 2 prior chemotherapy regimens. Exclusivity Protected Indication: In combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for treatment of patients with platinum-resistant, recurrent fallopian tube cancer who have received no more than 2 prior chemotherapy regimens. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent primary peritoneal cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 6, 2023 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: Either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitive recurrent fallopian tube cancer. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Therapeutic treatment of patients with ovarian cancer Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Treatment of fallopian tube carcinoma Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV fallopian tube cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Treatment of primary peritoneal carcinoma. Approved Labeled Indication: Avastin, in combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV epithelial ovarian, fallopian tube, orprimary peritoneal cancer following initial surgical resection. Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan, is indicated for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens. Avastin, in combination with carboplatin and paclitaxel, or with carboplatin and gemcitabine, followed by Avastin as a single agent, is indicated for the treatment of patients with platinum-sensitiverecurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Exclusivity Protected Indication: In combination with carboplatin and paclitaxel, followed by Avastin as a single agent, is indicated for the treatment of patients with stage III or IV primary peritoneal cancer following initial surgical resection. |
| Exclusivity Type: Orphan Drug Exclusivity | May 29, 2027 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Avonex (For Injection) (Intramuscular) interferon beta-1a
NDA Applicant: Biogen Inc. BLA No.: 103628 Prod. No.: 002 Rx (30MCG/0.5ML); 003 Rx (30MCG/0.5ML) BLA No.: 103628 Prod. No.: 001 Disc (30MCG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 17, 2003 | Orphan Designation: Treatment of multiple sclerosis. Approved Labeled Indication: Treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. |