Company 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.


Partner Therapeutics, Inc.
Leukine (For Injection) (Intravenous, Subcutaneous ) sargramostim
Drug Classes: Immunological Agents:Immunostimulants == leukocyte growth factor
NDA Applicant: Partner Therapeutics, Inc.      BLA No.: 103362  Prod. No.: 001 Rx (250MCG) BLA No.: 103362  Prod. No.: 002 Disc (500MCG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 5, 1998Orphan Designation: Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment.
Exclusivity Type: Orphan Drug ExclusivitySep 15, 2002Orphan Designation: To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia.
Approved Labeled Indication: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death.
Exclusivity Type: Orphan Drug ExclusivityMar 29, 2025Orphan Designation: Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome)
Approved Labeled Indication: LEUKINE_ is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]).
Exclusivity Protected Indication: to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS])

Pharmacia & Upjohn Company LLC
Genotropin (For Injection) (Subcutaneous) somatropin
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == recombinant human growth hormone
NDA Applicant: Pharmacia & Upjohn Company LLC      BLA No.: 020280  Prod. No.: 002 Rx (5MG); 003 Rx (0.6MG); 004 Rx (0.2MG); 005 Rx (0.8MG); 006 Rx (0.4MG); 007 Rx (12MG); 008 Rx (1MG); 009 Rx (1.2MG); 010 Rx (1.4MG); 011 Rx (1.6MG); 012 Rx (1.8MG); 013 Rx (2MG) BLA No.: 020280  Prod. No.: 001 Disc (1.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 31, 2004Orphan Designation: Treatment of adults with growth hormone deficiency.
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2007Orphan Designation: Treatment of short stature in patients with Prader-Willi syndrome.
Approved Labeled Indication: Long-term treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS).
Exclusivity Type: Orphan Drug ExclusivityJul 25, 2008Orphan Designation: Treatment of growth failure in children who were born small for gestational age.
Approved Labeled Indication: For long-term treatment of growth failure in children born small for gestational age who fail to manifest catch-up growth by two years of age.

Pharmacia & Upjohn Company LLC
Somavert (For Injection) (Subcutaneous) pegvisomant
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

PharmaEssentia Corporation
Besremi (Injection) (Subcutaneous) ropeginterferon alfa-2b-njft
Drug Classes: interferon alfa-2b
NDA Applicant: PharmaEssentia Corporation      BLA No.: 761166  Prod. No.: 001 Rx (500MCG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 12, 2028Orphan Designation: Treatment of polycythemia vera
Approved Labeled Indication: Treatment of adults with polycythemia vera
Exclusivity Protected Indication: Treatment of adults with polycythemia vera

Pharming Americas BV
Ruconest (For Injection) (Intravenous) C1 Esterase Inhibitor (Recombinant)
Drug Classes: Immunological Agents:Angioedema Agents
NDA Applicant: Pharming Americas BV      BLA No.: 125495  Prod. No.: 001 Rx (2100IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 16, 2021Orphan Designation: Treatment of (acute attacks of) angioedema caused by hereditary or acquired C1-esterase inhibitor deficiency.
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients.
Exclusivity Type: Ref. Product ExclusivityJul 16, 2026 

ProMetic BioTherapeutics, Inc.
Ryplazim (For Injection) (Intravenous) plasminogen, human-tvmh
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 

Protein Sciences Corporation
Flublok (Injection) (Intramuscular) Influenza Vaccine
Drug Classes: Immunological Agents:Vaccines
NDA Applicant: Protein Sciences Corporation      BLA No.: 125285  Prod. No.: 002 Rx (180UG/.5ML) BLA No.: 125285  Prod. No.: 001 Disc (135UG/.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityJan 16, 2025 



Last edited: 15 November 2022
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