Tradenames starting with "G"

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


Gamifant (Injection) (Intravenous) emapalumab-lzsg
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 761107  Prod. No.: 001 Rx (10MG/2ML (5MG/ML)); 002 Rx (50MG/10ML (5MG/ML)); 003 Rx (100MG/20ML (5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 20, 2025Orphan Designation: Treatment of hemophagocytic lymphohistiocytosis
Approved Labeled Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.
Exclusivity Protected Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy.

Gammagard Liquid (Injection) (Intravenous, Subcutaneous) Immune Globulin Infusion (Human)
Drug Classes: Immunological Agents:Immunoglobulins == human immunoglobulin G
NDA Applicant: Baxalta US Inc.      BLA No.: 125105  Prod. No.: 001 Rx (10% MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2019Orphan Designation: Treatment of multifocal motor neuropathy
Approved Labeled Indication: Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Gazyva (Injection) (Intravenous) obinutuzumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD20-directed cytolytic antibody
NDA Applicant: Genentech, Inc.      BLA No.: 125486  Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 1, 2020Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: GAZYVA, in combination with chlorambucil, is indicated for the treatment of patients with previously untreated chronic lymphocytic leukemia (CLL).
Exclusivity Protected Indication: Treatment of patients with previously untreated chronic lymphocytic leukemia in combination with chlorambucil.
Exclusivity Type: Orphan Drug ExclusivityFeb 26, 2023Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen
Exclusivity Protected Indication: in combination with bendamustine followed by Gazyva monotherapy, indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
Exclusivity Type: Orphan Drug ExclusivityNov 16, 2024Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma
Exclusivity Protected Indication: In combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.

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.

Gonal-f (For Injection) (Subcutaneous) follitropin alfa
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == Infertility Agents == gonadotropin
NDA Applicant: EMD Serono, Inc.      BLA No.: 020378  Prod. No.: 004 Rx (1,050IU (600IU/ML)); 005 Rx (450IU (600IU/ML)) BLA No.: 020378  Prod. No.: 001 Disc (75IU); 002 Disc (150IU); 003 Disc (37.5IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2007Orphan Designation: For the initiation and re-initiation of spermatogenesis in adult males with reproductive failure due to hypothalamic or pituitary dysfunction, hypogonadotropic hypogonadism. AMENDED indication 6/27/00: For the induction of spermatogenesis in men with pr
Approved Labeled Indication: For the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.

Granix (Injection) (Subcutaneous) tbo-filgrastim
NDA Applicant: Sicor Biotech UAB      BLA No.: 125294  Prod. No.: 001 Rx (300MCG/0.5ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Ref. Product ExclusivityAug 29, 2024 



Last edited: 15 November 2022
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