Data / Drug companies / Leuprolide acetate
Leuprolide acetate: 16 companies and 38 products in the FDA NDC directory
Leuprolide acetate is listed in the FDA National Drug Code Directory by 16 companies, with 38 products in commercial distribution. 11 of the products (28.9%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are kit; injection, suspension, extended release; injection, and the newest product started marketing on June 30, 2026.
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- Companies listing it
- 16
- Products
- 38
- Generic (ANDA) products
- 11 (28.9%)
- Application numbers
- 19
- Routes
- Subcutaneous
- Brand names
- Lupron Depot-PED, Lupron Depot, Vabrinty, Eligard, Eligard, Fensolvi, Lutrate Depot
- openFDA record search
- api.fda.gov
Companies that list leuprolide acetate
Ranked by number of products. Finished drugs in commercial distribution.
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| AbbVie Inc. | 12 | kit | New drug applications (NDA) | April 14, 2023 |
| Tolmar Inc. | 9 | injection, suspension, extended release; kit | New drug applications (NDA) | January 11, 2024 |
| Uronova Pharmaceuticals, Inc. | 4 | injection, suspension, extended release | Authorized generics (NDA) | December 15, 2025 |
| Avyxa Pharma, LLC | 1 | kit | New drug applications (NDA) | March 26, 2025 |
| Cipla USA Inc. | 1 | kit | New drug applications (NDA) | July 15, 2022 |
| Eugia US LLC | 1 | kit | Generic drugs (ANDA) | June 6, 2022 |
| Meitheal Pharmaceuticals Inc. | 1 | kit | Generic drugs (ANDA) | May 15, 2024 |
| NorthStar RxLLC | 1 | kit | Generic drugs (ANDA) | March 1, 2024 |
| Pai Holdings, LLC DBA Pai Pharma | 1 | kit | Generic drugs (ANDA) | February 1, 2025 |
| Par Health USA, LLC | 1 | injection | Generic drugs (ANDA) | June 30, 2026 |
| Sandoz Inc | 1 | kit | Generic drugs (ANDA) | August 4, 1998 |
| Sun Pharmaceutical Industries, Inc. | 1 | kit | Generic drugs (ANDA) | December 15, 2014 |
| Ubi Pharma Inc. | 1 | kit | Generic drugs (ANDA) | October 25, 2024 |
| Vgyaan Pharmaceuticals LLC | 1 | kit | Generic drugs (ANDA) | October 25, 2020 |
| Zydus Lifesciences Limited | 1 | kit | Generic drugs (ANDA) | January 8, 2026 |
| Zydus Pharmaceuticals USA Inc. | 1 | kit | Generic drugs (ANDA) | January 8, 2026 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Kit | 28 | 73.7% |
| Injection, suspension, extended release | 9 | 23.7% |
| Injection | 1 | 2.6% |
Marketing categories
| Marketing category | Products | Share |
|---|---|---|
| New drug applications (NDA) | 23 | 60.5% |
| Generic drugs (ANDA) | 11 | 28.9% |
| Authorized generics (NDA) | 4 | 10.5% |
Pharmacologic classes
| Class | Products |
|---|---|
| Gonadotropin Releasing Hormone Receptor Agonist | 10 |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.