LEUPROLIDE Drug Patent Profile
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Which patents cover Leuprolide, and what generic alternatives are available?
Leuprolide is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Ph Health, Sandoz, Somerset Theraps Llc, Sun Pharm, UBI, Zydus Pharms, and Invagen Pharms. and is included in eleven NDAs.
The generic ingredient in LEUPROLIDE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Leuprolide
A generic version of LEUPROLIDE was approved as leuprolide acetate by SANDOZ on August 4th, 1998.
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Questions you can ask:
- What is the 5 year forecast for LEUPROLIDE?
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Summary for LEUPROLIDE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Drug Prices: | Drug price information for LEUPROLIDE |
| DailyMed Link: | LEUPROLIDE at DailyMed |
US Patents and Regulatory Information for LEUPROLIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 215336-001 | Oct 28, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Somerset Theraps Llc | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 213829-001 | Aug 13, 2021 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Meitheal | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 075471-001 | Oct 25, 2000 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sun Pharm | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 078885-001 | Mar 9, 2009 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Eugia Pharma | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 212963-001 | Jun 6, 2022 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Genzyme | LEUPROLIDE ACETATE | leuprolide acetate | SOLUTION;SUBCUTANEOUS | 075721-001 | Nov 29, 2001 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
