Drug
Who makes leuprolide acetate?
17 companies list leuprolide acetate as a human prescription drug, including under the names Eligard, Fensolvi, LUTRATE DEPOT, Lupron Depot, Lupron Depot-PED, Vabrinty. Forms: injection; injection, suspension, extended release; kit. Routes: subcutaneous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing leuprolide acetate
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| AbbVie Inc.United States | kit | NDANDA019732, NDA020011, NDA020263 | 12 | 13 |
| TOLMAR Inc.United States | injection, suspension, extended release; kit | NDANDA021343, NDA021379, NDA021488 | 10 | 2 |
| URONOVA PHARMACEUTICALS, INC. | injection, suspension, extended release | NDA AUTHORIZED GENERICNDA021343, NDA021379, NDA021488 | 4 | 0 |
| Sun Pharmaceutical Industries LimitedIndia | kit | ANDAANDA078885 | 1 | 13 |
| Zydus Lifesciences LimitedIndia | kit | ANDAANDA215826 | 1 | 12 |
| CIPLA PHARMACEUTICALS LIMITEDIndia | kit | NDANDA205054 | 1 | 7 |
| Sandoz Industrial Products S.AAustria | kit | ANDAANDA074728 | 1 | 5 |
| Endo USA, Inc.United States | injection | ANDAANDA217437 | 1 | 3 |
| Amneal Ireland LimitedIreland | kit | ANDAANDA215336 | 1 | 1 |
| Avyxa GmbHSwitzerland | kit | NDANDA205054 | 1 | 1 |
| PAI Holdings, LLCUnited States | kit | ANDAANDA217957 | 1 | 1 |
| UBI Pharma Inc.Taiwan | kit | ANDAANDA217957 | 1 | 1 |
| Zydus Pharmaceuticals USA Inc.India | kit | ANDAANDA215826 | 1 | 1 |
| Eugia US LLC | kit | ANDAANDA212963 | 1 | 0 |
| Meitheal Pharmaceuticals, Inc. | kit | ANDAANDA075471 | 1 | 0 |
| NorthStar RxLLC | kit | ANDAANDA213829 | 1 | 0 |
| VGYAAN Pharmaceuticals LLC | kit | ANDAANDA213829 | 1 | 0 |
Bulk ingredient listings
- Aspen Oss B.V.Netherlands · 1 NDC
- Aurobindo Pharma LimitedIndia · 1 NDC
- Darmerica, LLCUnited States · 1 NDC
- Hemmo Pharmaceuticals Pvt. Ltd · 1 NDC
- MEDISCA Inc.United States · 1 NDC
- Polypeptide Laboratories Private LtdUnited States · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Sun Pharmaceutical Industries LimitedIndia · 1 NDC
- Zhejiang Peptites Biotech Co LtdChina · 1 NDC
- Zhejiang Supor Pharmaceuticals Co., Ltd · 1 NDC
Orange Book patents
5 unexpired patents list leuprolide acetate as the active ingredient, expiring between Mar 2028 and Dec 2041. Application holders: ABBVIE ENDOCRINE INC, TOLMAR INC, TOLMAR INTERNATIONAL LTD.
Enquiry
Common questions
- Who makes leuprolide acetate?
- 17 companies list leuprolide acetate as a human prescription drug in the openFDA NDC Directory, led by AbbVie Inc., TOLMAR Inc., URONOVA PHARMACEUTICALS, INC., Sun Pharmaceutical Industries Limited, Zydus Lifesciences Limited. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Eligard?
- 12 companies list leuprolide acetate under an abbreviated new drug application (ANDA), the application type used for generics, and 4 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies leuprolide acetate active ingredient?
- 10 companies list leuprolide acetate as a bulk ingredient, including Aspen Oss B.V., Aurobindo Pharma Limited, Darmerica, LLC, Hemmo Pharmaceuticals Pvt. Ltd.