LEUPROLIDE ACETATE Drug Patent Profile
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When do Leuprolide Acetate patents expire, and what generic alternatives are available?
Leuprolide Acetate is a drug marketed by Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, and Invagen Pharms. and is included in eight NDAs.
The generic ingredient in LEUPROLIDE ACETATE is leuprolide acetate. There are twenty-two drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Leuprolide Acetate
A generic version of LEUPROLIDE ACETATE was approved as leuprolide acetate by SANDOZ on August 4th, 1998.
Summary for LEUPROLIDE ACETATE
Recent Clinical Trials for LEUPROLIDE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Johns Hopkins Bloomberg School of Public Health | Phase 2 |
| Takeda | Phase 4 |
| Emory University | Phase 4 |
Medical Subject Heading (MeSH) Categories for LEUPROLIDE ACETATE
US Patents and Regulatory Information for LEUPROLIDE ACETATE
| 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 | INJECTABLE;INJECTION | 215336-001 | Oct 28, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 078885-001 | Mar 9, 2009 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Meitheal | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 075471-001 | Oct 25, 2000 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Invagen Pharms | LEUPROLIDE ACETATE FOR DEPOT SUSPENSION | leuprolide acetate | FOR SUSPENSION;INTRAMUSCULAR | 205054-001 | Aug 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Eugia Pharma | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 212963-001 | Jun 6, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Genzyme | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 075721-001 | Nov 29, 2001 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
