Leuprolide acetate - Generic Drug Details
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What are the generic 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, Meitheal, Rk Pharma, Sandoz, Sun Pharm, Abbvie Endocrine Inc, 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 forty-six patent family members in twenty-eight countries.
There are sixteen drug master file entries for leuprolide acetate. Nine suppliers are listed for this compound.
Summary for leuprolide acetate
International Patents: | 46 |
US Patents: | 3 |
Tradenames: | 9 |
Applicants: | 12 |
NDAs: | 21 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 194 |
Patent Applications: | 10,001 |
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 |
National Cancer Institute (NCI) | Phase 4 |
Pharmacology for leuprolide acetate
Drug Class | Gonadotropin Releasing Hormone Receptor Agonist |
Mechanism of Action | Gonadotropin Releasing Hormone Receptor Agonists |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-007 | Aug 15, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-003 | Apr 16, 1993 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 019732-001 | Jan 26, 1989 | RX | Yes | Yes | ⤷ 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 | ||||
Tolmar | FENSOLVI KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 213150-001 | May 1, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 |
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 | 020263-003 | Apr 16, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-004 | Apr 16, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-001 | Dec 22, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020708-001 | Mar 7, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020517-003 | Jun 17, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for leuprolide acetate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Peru | 20081842 | COMPOSICION DE LIBERACION SOSTENIDA Y METODOS PARA PRODUCIRLAS | ⤷ Try a Trial |
Colombia | 6180498 | UNA COMPOSICION DE LIBERACION SOSTENIDA QUE COMPRENDE UN PEPTIDO FISIOLOGICAMENTE ACTIVO SOLUBLE EN AGUA DISPERSADO UNIFORMEMENTE EN UNA MICROCAPSULA | ⤷ Try a Trial |
Australia | 2007335406 | Sustained-release composition and method for producing the same | ⤷ Try a Trial |
South Korea | 20090094272 | SUSTAINED-RELEASE COMPOSITION AND METHOD FOR PRODUCING THE SAME | ⤷ Try a Trial |
Colombia | 2023009588 | Métodos y sistemas para conjuntos de válvulas de jeringa mezcladoras | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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