Tradenames starting with "P"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Palynziq (Injection) (Subcutaneous) pegvaliase-pqpz
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

Panhematin (For Injection) (Intravenous) Hemin for Injection
NDA Applicant: Recordati Rare Diseases, Inc.      BLA No.: 101246  Prod. No.: 001 Rx (350MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 20, 1990Orphan 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
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 

Polivy (For Injection) (Intravenous) polatuzumab vedotin-piiq
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.

Portrazza (Injection) (Intravenous) necitumumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == epidermal growth factor receptor (EGFR) antagonist
NDA Applicant: Eli Lilly and Company      BLA No.: 125547  Prod. No.: 001 Rx (800MG/50ML (16MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 24, 2022Orphan 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))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 8, 2025Orphan 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_zary 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_zary syndrome (SS) after at least one prior systemic therapy.

Praluent (Injection) (Subcutaneous) alirocumab
Drug Classes: Cardiovascular Agents:Dyslipidemics, PCSK9 Inhibitor == PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 1, 2028Orphan 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
Drug Classes: humanized monoclonal antibody fragment (Fab)
NDA Applicant: Boehringer Ingelheim Pharmaceuticals, Inc.      BLA No.: 761025  Prod. No.: 001 Rx (2.5G/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 16, 2022Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJun 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 2, 1994Orphan 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
Drug Classes: Antineoplastics:Antineoplastics, Other == lymphocyte growth factor
NDA Applicant: Clinigen, Inc.      BLA No.: 103293  Prod. No.: 001 Rx (22MILLION INTERNATIONAL UNITS (1.3MG))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 5, 1999Orphan 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 ExclusivityJan 9, 2005Orphan Designation: Treatment of metastatic melanoma.
Approved Labeled Indication: Treatment of adults with metastatic melanoma.

Pulmozyme (Solution) (Inhalation) dornase alfa
Drug Classes: Respiratory Tract/ Pulmonary Agents:Cystic Fibrosis Agents == recombinant human deoxyribonuclease 1 (rhDNase) enzyme
NDA Applicant: Genentech, Inc.      BLA No.: 103532  Prod. No.: 001 Rx (2.5MG/2.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 30, 2000Orphan 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.



Last edited: 15 November 2022
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