DrugPatentWatch Database Preview
Leuprolide acetate - Generic Drug Details
What are the generic drug sources for leuprolide acetate and what is the scope of freedom to operate?
Leuprolide acetate
is the generic ingredient in nine branded drugs marketed by Gp-pharm Sa, Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Vgyaan, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in nineteen NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Leuprolide acetate has one hundred and sixty-nine patent family members in forty-two countries.
There are twenty-two drug master file entries for leuprolide acetate. Five suppliers are listed for this compound.
Summary for leuprolide acetate
| International Patents: | 169 |
| US Patents: | 3 |
| Tradenames: | 9 |
| Applicants: | 11 |
| NDAs: | 19 |
| Drug Master File Entries: | 22 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Clinical Trials: | 134 |
| Patent Applications: | 8,049 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for leuprolide acetate |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for leuprolide acetate |
| What excipients (inactive ingredients) are in leuprolide acetate? | leuprolide acetate excipients list |
| DailyMed Link: | leuprolide acetate at DailyMed |
Recent Clinical Trials for leuprolide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bharat Serums and Vaccines Limited | Phase 3 |
| Johns Hopkins University | Phase 1 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 1 |
Medical Subject Heading (MeSH) Categories for leuprolide acetate
Paragraph IV (Patent) Challenges for LEUPROLIDE ACETATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LUPRON DEPOT | INJECTABLE;INJECTION | leuprolide acetate | 019732 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| Sandoz | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 074728-001 | Aug 4, 1998 | AP | RX | No | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-003 | Jun 17, 2011 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Genzyme | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 075721-001 | Nov 29, 2001 | DISCN | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Sun Pharm | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 078885-001 | Mar 9, 2009 | AP | RX | No | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | |||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-006 | Jan 21, 1994 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | Y | ⤷ Try it Free | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for leuprolide acetate
International Patents for leuprolide acetate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Czech Republic | 303134 | ⤷ Try it Free |
| Japan | 4686653 | ⤷ Try it Free |
| South Africa | 200302944 | ⤷ Try it Free |
| Singapore | 180015 | ⤷ Try it Free |
| Australia | 1331200 | ⤷ Try it Free |
| World Intellectual Property Organization (WIPO) | 0230393 | ⤷ Try it Free |
| Japan | 4564098 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
