DrugPatentWatch Database Preview
Leuprolide acetate - Generic Drug Details
» See Plans and Pricing
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, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in eighteen NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.Leuprolide acetate has one hundred and ninety-five patent family members in forty-two countries.
There are twenty-two drug master file entries for leuprolide acetate. Four suppliers are listed for this compound.
Summary for leuprolide acetate
| International Patents: | 195 |
| US Patents: | 8 |
| Tradenames: | 9 |
| Applicants: | 10 |
| NDAs: | 18 |
| Drug Master File Entries: | 22 |
| Suppliers / Packagers: | 4 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 128 |
| Patent Applications: | 7,490 |
| 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 |
| DailyMed Link: | leuprolide acetate at DailyMed |
Recent Clinical Trials for leuprolide acetate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| ECOG-ACRIN Cancer Research Group | Phase 3 |
| Alliance for Clinical Trials in Oncology | Phase 3 |
| AbbVie | Early 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 | 021731-001 | Dec 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-008 | Aug 15, 2011 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021379-001 | Jul 24, 2002 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Abbvie Endocrine Inc | LUPRON | leuprolide acetate | INJECTABLE;INJECTION | 019010-001 | Apr 9, 1985 | DISCN | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Genzyme | LEUPROLIDE ACETATE | leuprolide acetate | INJECTABLE;INJECTION | 075721-001 | Nov 29, 2001 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Tolmar | FENSOLVI KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 213150-001 | May 1, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 |
|---|---|---|
| Japan | 2004238400 | Start Trial |
| China | 1474685 | Start Trial |
| Norway | 331883 | Start Trial |
| Brazil | 0008197 | Start Trial |
| South Korea | 20030064401 | Start Trial |
| Peru | 20030066 | Start Trial |
| Australia | 9293101 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
