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 | Jan 23, 2022 | Orphan Designation: Treatment of hypoparathyroidism Approved Labeled Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism Exclusivity Protected Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism |
pegademase bovine (Injection) (Intramuscular) Adagen
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. |
pegaspargase (Injection) (Intravenous, Intramuscular) Oncaspar
NDA Applicant: Servier Pharmaceuticals LLC BLA No.: 103411 Prod. No.: 001 Rx (3,750IU/5ML(750IU/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. |
pegfilgrastim (Injection) (Subcutaneous) Neulasta; Neulasta Onpro
NDA Applicant: Amgen Inc. BLA No.: 125031 Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9856287 Refolding proteins using a chemically controlled redox state Claim Types: Process Pat. Sub. Date(s): None | Jun 21, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 13, 2022 | Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome) |
pegloticase (Injection) (Intravenous) Krystexxa
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 125293 Prod. No.: 001 Rx (8MG/1ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 14, 2017 | Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional treatment |
pegvaliase-pqpz (Injection) (Subcutaneous) Palynziq
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 761079 Prod. No.: 001 Rx (2.5MG/0.5ML); 002 Rx (10MG/0.5ML); 003 Rx (20MG/ML)
| 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 |
pegvisomant (For Injection) (Subcutaneous) Somavert
NDA Applicant: Pharmacia & Upjohn Company LLC BLA No.: 021106 Prod. No.: 001 Rx (10MG); 002 Rx (15MG); 003 Rx (20MG); 004 Rx (25MG); 005 Rx (30MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 25, 2010 | Orphan Designation: Treatment of acromegaly. Approved Labeled Indication: Treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapies, or for whom these therapies are not appropriate |
pembrolizumab (For Injection) (Intravenous) Keytruda
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 125514 Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514 Prod. No.: 001 Disc (50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 4, 2021 | Orphan Designation: Treatment of Stage IIB through IV malignant melanoma Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 18, 2022 | Orphan Designation: Treatment of Stage IIB through IV malignant melanoma Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma. Exclusivity Protected Indication: Initial treatment of patients with unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 14, 2024 | Orphan Designation: Treatment of Hodgkin lymphoma. Approved Labeled Indication: Treatment for adult and pediatric patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. Exclusivity Protected Indication: Treatment of adult and pediatric patients with refractory classical Hodgkin Lymphoma, or who have relapsed after 3 or more prior lines of therapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 22, 2024 | Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. Exclusivity Protected Indication: Treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) >or =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu targeted therapy excluding microsatellite instability-high or mismatch repair deficient gastric or gastroesophageal adenocarcinomas that have progressed and have no satisfactory alternative treatment options. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 13, 2025 | Orphan Designation: Treatment of primary mediastinal B cell lymphoma. Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2025 | Orphan Designation: Treatment of hepatocellular carcinoma (HCC) Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 19, 2025 | Orphan Designation: Treatment of Merkel cell carcinoma Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 15, 2026 | Orphan Designation: Treatment of Stage IIB through IV malignant melanoma Approved Labeled Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Exclusivity Protected Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 30, 2026 | Orphan Designation: Treatment of esophageal carcinoma Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. Exclusivity Protected Indication: Indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy. |
| Exclusivity Type: Orphan Drug Exclusivity | May 5, 2028 | Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma Approved Labeled Indication: in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma Exclusivity Protected Indication: for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, excluding patients covered by Keytruda's previous indication for gastric or GEJ adenocarcinoma approved on September 22, 2017 |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 3, 2028 | Orphan Designation: Treatment of Stage IIB through IV malignant melanoma Approved Labeled Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection Exclusivity Protected Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection, and adjuvant treatment of pediatric (12 years and older) patients with Stage III melanoma following complete resection |
pertuzumab (Injection) (Intravenous) Perjeta
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 |
plasminogen, human-tvmh (For Injection) (Intravenous) Ryplazim
NDA Applicant: ProMetic BioTherapeutics, Inc. BLA No.: 125659 Prod. No.: 001 Rx (68.8MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 4, 2028 | Orphan Designation: Treatment of hypoplasminogenemia, or type I plasminogen deficiency Approved Labeled Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia). Exclusivity Protected Indication: Treatment of patients with plasminogen deficiency type 1 (hypoplasminogenemia) |
| Exclusivity Type: Ref. Product Exclusivity | Jun 4, 2033 |
Pneumococcal 15-valent Conjugate Vaccine (Injection) (Intramuscular) Vaxneuvance
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 125741 Prod. No.: 001 Rx (2.0UG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jul 16, 2033 |
polatuzumab vedotin-piiq (For Injection) (Intravenous) Polivy
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 |
Protein C Concentrate (Human) (For Injection) (Intravenous) Ceprotin
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125234 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 30, 2014 | Orphan Designation: For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans. Approved Labeled Indication: Prevention and treatment of venous thrombosis and purpura fulminans |
Prothrombin Complex Concentrate (Human) (For Injection) (Intravenous) Kcentra
NDA Applicant: CSL Behring GmbH BLA No.: 125421 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding. Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 13, 2020 | Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure. Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, e.g., warfarin) in adult patients with the need for urgent surgery/invasive procedure. |