Generic names starting with "P"

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.


parathyroid hormone (For Injection) (Subcutaneous) Natpara
Drug Classes: Metabolic Bone Disease Agents == parathyroid hormone
NDA Applicant: NPS Pharmaceuticals, Inc.      BLA No.: 125511  Prod. No.: 001 Rx (25MCG); 002 Rx (50MCG); 003 Rx (75MCG); 004 Rx (100MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 23, 2022Orphan 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
Drug Classes: bovine intestinal adenosine deaminase
NDA Applicant: Leadiant Biosciences, Inc      BLA No.: 019818  Prod. No.: 001 Disc (375UNITS/1.5ML (250UNITS/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 21, 1997Orphan Designation: For enzyme replacement therapy for ADA deficiency in patients with severe combined immunodeficiency.

pegaspargase (Injection) (Intravenous, Intramuscular) Oncaspar
Drug Classes: Antineoplastics:Antineoplastics, Other == asparagine specific enzyme
NDA Applicant: Servier Pharmaceuticals LLC      BLA No.: 103411  Prod. No.: 001 Rx (3,750IU/5ML(750IU/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 1, 2001Orphan 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
Drug Classes: leukocyte growth factor
NDA Applicant: Amgen, Inc.      BLA No.: 125031  Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)
PatentsExpirationPatented Use
Pat. No. 9856287 Refolding proteins using a chemically controlled redox state
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 13, 2022Orphan 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
Drug Classes: Antigout Agents
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 125293  Prod. No.: 001 Rx (8MG/1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 14, 2017Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2025Orphan 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
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == growth hormone receptor antagonist
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 25, 2010Orphan 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
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human programmed death receptor-1 (PD-1)-blocking antibody
NDA Applicant: Merck Sharp & Dohme Corp.      BLA No.: 125514  Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 4, 2021Orphan 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 ExclusivityDec 18, 2022Orphan 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 ExclusivityMar 14, 2024Orphan 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 ExclusivitySep 22, 2024Orphan 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 ExclusivityJun 13, 2025Orphan 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 ExclusivityNov 9, 2025Orphan 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 ExclusivityDec 19, 2025Orphan 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 ExclusivityFeb 15, 2026Orphan 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 ExclusivityJul 30, 2026Orphan 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 ExclusivityMay 5, 2028Orphan 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

pertuzumab (Injection) (Intravenous) Perjeta
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == HER2/neu receptor antagonist
NDA Applicant: Genentech, Inc.      BLA No.: 125409  Prod. No.: 001 Rx (420MG/14ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJun 8, 2024 

plasminogen, human-tvmh (For Injection) (Intravenous) Ryplazim
NDA Applicant: ProMetic BioTherapeutics, Inc.      BLA No.: 125659  Prod. No.: 001 Rx (68.8MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 4, 2028Orphan 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 ExclusivityJun 4, 2033 

Pneumococcal 15-valent Conjugate Vaccine (Injection) (Intramuscular) Vaxneuvance
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Merck Sharp & Dohme Corp.      BLA No.: 125741  Prod. No.: 001 Rx (2.0UG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJul 16, 2033 

polatuzumab vedotin-piiq (For Injection) (Intravenous) Polivy
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Genentech, Inc.      BLA No.: 761121  Prod. No.: 001 Rx (140MG); 002 Rx (30MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 10, 2026Orphan 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.

Protein C Concentrate (Human) (For Injection) (Intravenous) Ceprotin
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == anticoagulant
NDA Applicant: Baxalta US Inc.      BLA No.: 125234  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 30, 2014Orphan 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
Drug Classes: blood coagulation factor
NDA Applicant: CSL Behring GmbH      BLA No.: 125421  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan 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 ExclusivityDec 13, 2020Orphan 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.



Last edited: 15 November 2022
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