Leuprolide acetate - Generic Drug Details
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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 Invagen Pharms, Ortho Mcneil Janssen, Amneal, Eugia Pharma, Genzyme, Sandoz, Sun Pharm, Teva Pharms Usa, Vgyaan, Abbvie Endocrine Inc, Tolmar Therap, Tolmar, and Abbvie Endocrine, and is included in twenty-one 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 sixteen drug master file entries for leuprolide acetate. Ten suppliers are listed for this compound.
Summary for leuprolide acetate
| International Patents: | 169 |
| US Patents: | 3 |
| Tradenames: | 9 |
| Applicants: | 13 |
| NDAs: | 21 |
| Drug Master File Entries: | 16 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 194 |
| Patent Applications: | 5,855 |
| 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 |
|---|---|
| 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
Expired US Patents for leuprolide acetate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-007 | Aug 15, 2011 | See Plans and Pricing | See Plans and Pricing |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-006 | Jan 21, 1994 | See Plans and Pricing | See Plans and Pricing |
| Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-001 | Oct 22, 1990 | See Plans and Pricing | See Plans and Pricing |
| Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-007 | Aug 15, 2011 | See Plans and Pricing | See Plans and Pricing |
| Tolmar Therap | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021343-001 | Jan 23, 2002 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for leuprolide acetate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Poland | 204903 | See Plans and Pricing | |
| Ukraine | 97125 | КОМПОЗИЦИЯ ПРОДОЛЖИТЕЛЬНОГО ВЫСВОБОЖДЕНИЯ И СПОСОБ ЕЕ ПОЛУЧЕНИЯ;КОМПОЗИЦІЯ ТРИВАЛОГО ВИВІЛЬНЕННЯ І СПОСІБ ЇЇ ОДЕРЖАННЯ (SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME) | See Plans and Pricing |
| Argentina | 064381 | COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLA | See Plans and Pricing |
| Czech Republic | 306327 | Kompozice s regulovaným uvolňováním a způsob její výroby (Controlled release composition and process for preparing thereof) | See Plans and Pricing |
| China | 100536922 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
