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 | May 24, 2025 | Orphan Designation: Treatment of hyperphenylalaninemia Approved Labeled Indication: Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management Exclusivity Protected Indication: Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L on existing management |
Panhematin (For Injection) (Intravenous) Hemin for Injection
NDA Applicant: Recordati Rare Diseases, Inc. BLA No.: 101246 Prod. No.: 001 Rx (350MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 20, 1990 | Orphan Designation: Amelioration of recurrent attacks of acute intermittent porphyria (AIP) temporarily related to the menstrual cycle in susceptible women and similar symptoms which occur in other patients with AIP, porphyria variegata and hereditary coproporphyria. |
Perjeta (Injection) (Intravenous) pertuzumab
NDA Applicant: Genentech, Inc. BLA No.: 125409 Prod. No.: 001 Rx (420MG/14ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jun 8, 2024 |
Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
NDA Applicant: Genentech, Inc. BLA No.: 761121 Prod. No.: 001 Rx (140MG); 002 Rx (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 10, 2026 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: POLIVY in combination with bendamustine and a rituximab product is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. Exclusivity Protected Indication: In combination with bendamustine and a rituximab product for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, after at least two prior therapies. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 19, 2030 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: in combination with a rituximab product, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index score of 2 or greater Exclusivity Protected Indication: treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) and who have an International Prognostic Index score of 2 or greater |
Portrazza (Injection) (Intravenous) necitumumab
NDA Applicant: Eli Lilly and Company BLA No.: 125547 Prod. No.: 001 Rx (800MG/50ML (16MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 24, 2022 | Orphan Designation: Treatment of squamous non-small cell lung cancer Approved Labeled Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. Limitation of Use: PORTRAZZA is not indicated for treatment of non-squamous non-small cell lung cancer. Exclusivity Protected Indication: Use in combination with gemcitabine and cisplatin, for first-line treatment of patients with metastatic, squamous, non-small cell lung cancer. PORTRAZZA is not indicated for treatment of non-squamous, non-small cell lung cancer |
Poteligeo (Injection) (Intravenous) mogamulizumab-kpkc
NDA Applicant: Kyowa Kirin, Inc. BLA No.: 761051 Prod. No.: 001 Rx (20MG/5ML (4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 8, 2025 | Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma. Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. Exclusivity Protected Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. |
Praluent (Injection) (Subcutaneous) alirocumab
NDA Applicant: Regeneron Pharmaceuticals, Inc. BLA No.: 125559 Prod. No.: 001 Rx (75MG/ML); 002 Rx (150MG/ML) BLA No.: 125559 Prod. No.: 003 Disc (75MG/ML); 004 Disc (150MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2028 | Orphan Designation: Treatment of homozygous familial hypercholesterolemia Approved Labeled Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C Exclusivity Protected Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C |
Praxbind (Injection) (Intravenous) idarucizumab
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc. BLA No.: 761025 Prod. No.: 001 Rx (2.5G/50ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 16, 2022 | Orphan Designation: To reverse the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure Approved Labeled Indication: For use in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding Exclusivity Protected Indication: For use in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding |
Prevnar 20 (Injection) (Intramuscular) 20-valent Pneumococcal Conjugate Vaccine
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 125731 Prod. No.: 001 Rx (0.5 ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jun 8, 2033 |
Prolastin, Prolastin-C (For Injection) (Intravenous) Alpha-1-Proteinase Inhibitor (Human)
NDA Applicant: Grifols Therapeutics LLC BLA No.: 103174 Prod. No.: 001 Rx (1000MG); 003 Rx (1000MG/20ML); 004 Rx (4000MG/80ML); 005 Rx (500MG/10ML) BLA No.: 103174 Prod. No.: 002 Disc (500MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 2, 1994 | Orphan Designation: For replacement therapy in the alpha-1-proteinase inhibitor congenital deficiency state. Approved Labeled Indication: For chronic replacement therapy of individuals having congenital deficiency of alpha1- proteinase inhibitor with clinically demonstrable panacinar emphysema. |
Proleukin (For Injection) (Intravenous) aldesleukin
NDA Applicant: Clinigen, Inc. BLA No.: 103293 Prod. No.: 001 Rx (22MILLION INTERNATIONAL UNITS (1.3MG))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 1999 | Orphan Designation: Treatment of metastatic renal cell carcinoma. Approved Labeled Indication: Treatment of adults (>18 years old) with metastatic renal cell carcinoma. |
| Exclusivity Type: Orphan Drug Exclusivity | Jan 9, 2005 | Orphan Designation: Treatment of metastatic melanoma. Approved Labeled Indication: Treatment of adults with metastatic melanoma. |
Prolia (Injection) (Subcutaneous) denosumab
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 |
Pulmozyme (Solution) (Inhalation) dornase alfa
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. |