Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 20, 2025 | Orphan 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)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125105 Prod. No.: 001 Rx (10% MG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2019 | Orphan 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). |
Gammaked, Gamunex-C (Injection) (Intravenous; Subcutaneous) Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified
NDA Applicant: Grifols Therapeutics LLC BLA No.: 125046 Prod. No.: 001 Rx (2.5G); 002 Rx (5G); 003 Rx (10G); 004 Rx (1G); 005 Rx (20G); 006 Rx (40G); 007 Rx (2.5G); 008 Rx (5G); 009 Rx (10G); 010 Rx (20G); 011 Rx (40G)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 12, 2015 | Orphan 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. |
Gazyva (Injection) (Intravenous) obinutuzumab
NDA Applicant: Genentech, Inc. BLA No.: 125486 Prod. No.: 001 Rx (1,000MG/40ML (25MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 1, 2020 | Orphan 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 Exclusivity | Feb 26, 2023 | Orphan 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 Exclusivity | Nov 16, 2024 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 31, 2004 | Orphan Designation: Treatment of adults with growth hormone deficiency. |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2007 | Orphan 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 Exclusivity | Jul 25, 2008 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 24, 2007 | Orphan 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: UAB Teva Baltics BLA No.: 125294 Prod. No.: 001 Rx (300MCG/0.5ML); 002 Rx (480MCG/0.8ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Aug 29, 2024 |