Generic names starting with "G"

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.


galsulfase (Injection) (Intravenous) Naglazyme
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125117  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 31, 2012Orphan 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.

gemtuzumab ozogamicin (For Injection) (Intravenous) Mylotarg
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == CD33-directed antibody-drug conjugate
NDA Applicant: Wyeth Pharmaceuticals LLC      BLA No.: 761060  Prod. No.: 001 Rx (4.5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 17, 2007Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
Exclusivity Type: Orphan Drug ExclusivitySep 1, 2024Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Protected Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older
Exclusivity Type: Orphan Drug ExclusivityJun 16, 2027Orphan Designation: Treatment of acute myeloid leukemia
Approved Labeled Indication: Mylotarg_ is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older.
Exclusivity Protected Indication: For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older

glucarpidase (For Injection) (Intravenous) Voraxaze
Drug Classes: carboxypeptidase
NDA Applicant: BTG International Inc.      BLA No.: 125327  Prod. No.: 001 Rx (1,000UNITS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 17, 2019Orphan Designation: Treatment of patients at risk of methotrexate toxicity
Approved Labeled Indication: Treatment of toxic (>1 micromole/liter) plasma methotrexate concentrations in patients with delayed methotrexate clearance due to impaired renal function.

golimumab (Injection) (Intravenous) Simponi Aria
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: Janssen Biotech, Inc.      BLA No.: 125433  Prod. No.: 001 Rx (50MG/4ML (12.5MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 29, 2027Orphan Designation: Treatment of polyarticular juvenile idiopathic arthritis in patients 0 through 18 years of age.
Approved Labeled Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older
Exclusivity Protected Indication: treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 to 18 years of age



Last edited: 15 November 2022
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