Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 10, 2004 | Orphan Designation: Prevention of acute renal allograft rejection. Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as a part of an immunosuppressive regimen that includes cyclosporine and corticosteroids. |
daratumumab (Injection) (Intravenous) Darzalex
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761036 Prod. No.: 001 Rx (100MG/5ML); 002 Rx (400MG/20ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2022 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent Exclusivity Protected Indication: For the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or are double refractory to a proteasome inhibitor and an immunomodulatory agent |
Exclusivity Type: Orphan Drug Exclusivity | Nov 21, 2023 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: DARZALEX in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. |
Exclusivity Type: Orphan Drug Exclusivity | Jun 16, 2024 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: In combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, not including any overlap with the exclusivity awarded for the 2015 approval for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and immunomodulary agent or are double refractory to a proteasome inhibitor and immunomodulatory agent. |
Exclusivity Type: Orphan Drug Exclusivity | May 7, 2025 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: DARZALEX is indicated in combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; and in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; and in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor; and as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent. Exclusivity Protected Indication: In combination with bortezomib, melphalen, and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant |
Exclusivity Type: Orphan Drug Exclusivity | Sep 26, 2026 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: Treatment of adult patients with multiple myeloma in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) and in patients with relapsed or refractory multiple myeloma who have received at least 1 prior therapy; in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with bortezomib, thalidomide and dexamethasone in newly diagnosed patients who are eligible for ASCT; in combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy; in combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor (PI); and as monotherapy, in patients who have received at least 3 prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immodulatory agent. Exclusivity Protected Indication: Indicated for the treatment of adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant |
daratumumab and hyaluronidase-fihj (Injection) (Subcutaneous) Darzalex Faspro
NDA Applicant: Janssen Biotech, Inc. BLA No.: 761145 Prod. No.: 001 Rx (1800MG/15ML; 30,000UNITS/15ML (120MG/2,000UNITS/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jan 15, 2028 | Orphan Designation: treatment of light-chain (AL) amyloidosis Approved Labeled Indication: in combination with bortezomib, cyclophosphamide and dexamethasone for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis Exclusivity Protected Indication: treatment of adult patients with newly diagnosed light chain (AL) amyloidosis |
delandistrogene moxeparvovec-rokl (Suspension) (Intravenous) ELEVIDYS
NDA Applicant: Sarepta Therapeutics, Inc. BLA No.: 125781 Prod. No.: 001 Rx (1.33 _10E14 vector genomes (vg)/kg/bodyweight(bw))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2030 | Orphan Designation: Treatment of Duchenne Muscular Dystrophy Approved Labeled Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene Exclusivity Protected Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene |
Dengue Tetravalent Vaccine, Live (For Injection) (Subcutaneous) Dengvaxia
NDA Applicant: Sanofi Pasteur Inc. BLA No.: 125682 Prod. No.: 001 Rx (4.5-6.0 LOG10 CCID50 CCID50: CELL CULTURE INFECTIOUS DOSE 50)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Ref. Product Exclusivity | May 1, 2031 |
denileukin diftitox (Injection) (Intravenous) Ontak
NDA Applicant: Eisai, Incorporated BLA No.: 103767 Prod. No.: 001 Disc (150MCG/ML (300MCG/2ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2006 | Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma Approved Labeled Indication: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. |
denosumab (Injection) (Subcutaneous) Prolia
NDA Applicant: Amgen Inc. BLA No.: 125320 Prod. No.: 001 Rx (60MG/ML) BLA No.: 125320 Prod. No.: 002 Disc (60MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7364736 Antibodies to OPGL Claim Types: Compound; Composition Pat. Sub. Date(s): None | Feb 19, 2025 | |
Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2025 | |
Pat. No. 7928205 Methods for refolding of recombinant antibodies Claim Types: Process Pat. Sub. Date(s): None | Feb 12, 2027 | |
Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Claim Types: Formulation Pat. Sub. Date(s): None | Nov 30, 2023 | |
Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Claim Types: Process; Cell culture Pat. Sub. Date(s): None | Aug 5, 2031 | |
Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
Pat. No. 9228168 Feed media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 19, 2030 | |
Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Claim Types: Process Pat. Sub. Date(s): None | Nov 14, 2030 | |
Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Claim Types: Compound; Process Pat. Sub. Date(s): None | Feb 20, 2034 | |
Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 22, 2027 | |
Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Claim Types: Device Pat. Sub. Date(s): None | Jul 28, 2035 | |
Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Claim Types: Cell culture medium; Process Pat. Sub. Date(s): None | May 29, 2034 | |
Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Claim Types: Device; Process Pat. Sub. Date(s): None | May 13, 2035 | |
Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Claim Types: Process Pat. Sub. Date(s): None | Jul 21, 2037 | |
Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 5, 2035 | |
Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Oct 30, 2034 | |
Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 |
denosumab (Injection) (Subcutaneous) Xgeva
NDA Applicant: Amgen Inc. BLA No.: 125320 Prod. No.: 003 Rx (120MG/1.7ML (70MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat. No. 7364736 Antibodies to OPGL Claim Types: Compound; Composition Pat. Sub. Date(s): None | Feb 19, 2025 | |
Pat. No. 7427659 Process for purifying proteins in a hydrophobic interaction chromatography flow-through fraction Claim Types: Process Pat. Sub. Date(s): None | Mar 15, 2025 | |
Pat. No. 7928205 Methods for refolding of recombinant antibodies Claim Types: Process Pat. Sub. Date(s): None | Feb 12, 2027 | |
Pat. No. 8058418 Polynucleotides encoding heavy and light chains of antibodies to OPGL Claim Types: Formulation Pat. Sub. Date(s): None | Nov 30, 2023 | |
Pat. No. 9012178 Dipeptides to enhance yield and viability from cell cultures Claim Types: Process; Cell culture Pat. Sub. Date(s): None | Aug 5, 2031 | |
Pat. No. 9133493 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
Pat. No. 9228168 Feed media Claim Types: Process; Cell culture medium Pat. Sub. Date(s): None | Jan 19, 2030 | |
Pat. No. 9320816 Methods of treating cell culture media for use in a bioreactor Claim Types: Process Pat. Sub. Date(s): None | Nov 14, 2030 | |
Pat. No. 9328134 Carbohydrate phosphonate derivatives as modulators of glycosylation Claim Types: Compound; Process Pat. Sub. Date(s): None | Feb 20, 2034 | |
Pat. No. 9359435 Methods for modulating mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 22, 2027 | |
Pat. No. 9388447 Method for culturing mammalian cells to improve recombinant protein production Claim Types: Process Pat. Sub. Date(s): None | Apr 20, 2032 | |
Pat. No. 9481901 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
Pat. No. 10167492 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
Pat. No. 10513723 Decreasing ornithine production to decrease high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
Pat. No. 10583397 Process control systems and methods for use with filters and filtration processes Claim Types: Device Pat. Sub. Date(s): None | Jul 28, 2035 | |
Pat. No. 10822630 Process for manipulating the level of glycan content of a glycoprotein Claim Types: Process Pat. Sub. Date(s): None | Dec 1, 2035 | |
Pat. No. 10894972 Methods for increasing mannose content of recombinant proteins Claim Types: Cell culture medium; Process Pat. Sub. Date(s): None | May 29, 2034 | |
Pat. No. 11077404 Process control systems and methods for use with filters and filtration processes Claim Types: Device; Process Pat. Sub. Date(s): None | May 13, 2035 | |
Pat. No. 11098079 Charged depth filtration of antigen-binding proteins Claim Types: Process Pat. Sub. Date(s): None | Jul 21, 2037 | |
Pat. No. 11130980 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Apr 5, 2035 | |
Pat. No. 11254963 Increasing ornithine accumulation to increase high mannose glycoform content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Dec 9, 2034 | |
Pat. No. 11299760 Use of monensin to regulate glycosylation of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Oct 30, 2034 | |
Pat. No. 11434514 Methods for increasing mannose content of recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | May 29, 2034 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2020 | Orphan Designation: Treatment of patients with giant cell tumor of bone Approved Labeled Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Exclusivity Protected Indication: Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. |
Exclusivity Type: Orphan Drug Exclusivity | Dec 5, 2021 | Orphan Designation: Treatment of hypercalcemia in malignancy Approved Labeled Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy. Exclusivity Protected Indication: To treat hypercalcemia of malignancy refractory to biphosphonate therapy. |
Digoxin Immune Fab (Ovine) (For Injection) (Intravenous) Digibind
NDA Applicant: Wellcome Foundation Limited Wellcome Research Laboratories BLA No.: 103141 Prod. No.: 001 Disc (38MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Apr 22, 1993 | Orphan Designation: Treatment of potentially life threatening digitalis intoxication in patients who are refractory to management by conventional therapy. |
dinutuximab (Injection) (Intravenous) Unituxin
NDA Applicant: United Therapeutics Corporation BLA No.: 125516 Prod. No.: 001 Rx (17.5MG/5ML (3.5MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 10, 2022 | Orphan Designation: Treatment of neuroblastoma Approved Labeled Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy Exclusivity Protected Indication: For use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy |
dornase alfa (Solution) (Inhalation) Pulmozyme
NDA Applicant: Genentech, Inc. BLA No.: 103532 Prod. No.: 001 Rx (2.5MG/2.5ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 30, 2000 | Orphan Designation: To reduce mucous viscosity and enable the clearance of airway secretions in patients with cystic fibrosis. Approved Labeled Indication: In conjunction with standard therapies in the management of cystic fibrosis patients to reduce the frequency of respiratory infections requiring parenteral antibiotics and to improve pulmonary function. |
dupilumab (Injection) (Subcutaneous) Dupixent
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 761055 Prod. No.: 001 Rx (300MG/2ML); 003 Rx (200MG/1.14ML); 004 Rx (300MG/2ML); 005 Rx (200MG/1.14ML); 006 Rx (100MG/0.67ML) BLA No.: 761055 Prod. No.: 002 Disc (300MG/2ML)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | May 20, 2029 | Orphan Designation: Treatment of eosinophilic esophagitis Approved Labeled Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) Exclusivity Protected Indication: Treatment of adult and pediatric patients aged 12 years and older, weighing at least 40 kg, with eosinophilic esophagitis (EoE) |
durvalumab (Injection) (Intravenous) Imfinzi
NDA Applicant: AstraZeneca UK Ltd BLA No.: 761069 Prod. No.: 001 Rx (500MG/10ML (50MG/ML)); 002 Rx (120MG/2.4ML (50MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 27, 2027 | Orphan Designation: Treatment of small cell lung cancer Approved Labeled Indication: IMFINZI is indicated for use, in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). Exclusivity Protected Indication: Indicated in combination with etoposide and either carboplatin or cisplatin, for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). |
Exclusivity Type: Orphan Drug Exclusivity | Sep 2, 2029 | Orphan Designation: Treatment of biliary tract cancer Approved Labeled Indication: In combination with gemcitabine and cisplatin, for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) Exclusivity Protected Indication: treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) |
Exclusivity Type: Orphan Drug Exclusivity | Oct 21, 2029 | Orphan Designation: Treatment of hepatocellular carcinoma Approved Labeled Indication: In combination with tremelimumab-actl for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) Exclusivity Protected Indication: treatment of adult patients with unresectable hepatocellular carcinoma (uHCC) |