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, Abbvie Endocrine Inc, Tolmar, Amneal, Eugia Pharma, Genzyme, Meitheal, Rk Pharma, Sandoz, Sun Pharm, UBI, and Abbvie Endocrine, and is included in twenty-two NDAs. There are four 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. Eleven suppliers are listed for this compound.
Summary for LEUPROLIDE ACETATE
International Patents: | 46 |
US Patents: | 4 |
Tradenames: | 9 |
Applicants: | 13 |
NDAs: | 22 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 11 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 196 |
Patent Applications: | 10,001 |
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 |
---|---|
NRG Oncology | Phase 2 |
Johns Hopkins Bloomberg School of Public Health | Phase 2 |
Takeda | 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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-005 | Jan 21, 1994 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Abbvie Endocrine Inc | LUPRON DEPOT | leuprolide acetate | INJECTABLE;INJECTION | 020011-002 | Oct 26, 1995 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 020263-008 | Aug 15, 2011 | ⤷ Subscribe | ⤷ Subscribe |
Abbvie Endocrine Inc | LUPRON DEPOT-PED KIT | leuprolide acetate | POWDER;INTRAMUSCULAR | 020263-006 | Jan 21, 1994 | ⤷ Subscribe | ⤷ Subscribe |
Tolmar | ELIGARD KIT | leuprolide acetate | POWDER;SUBCUTANEOUS | 021731-001 | Dec 14, 2004 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LEUPROLIDE ACETATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 116847900 | 用于混合注射器阀门组件的系统和方法 (Systems and methods for hybrid syringe valve assembly) | ⤷ Subscribe |
Georgia, Republic of | P20125597 | SUSTAINED-RELEASE COMPOSITION AND PRODUCTION METHOD THEREOF | ⤷ Subscribe |
Brazil | PI0720582 | COMPOSIÇÃO DE LIBERAÇÃO PROLONGADA, PROCESSO PARA A PREPARAÇÃO DA MESMA, COMPOSIÇÃO FARMACÊUTICA, AGENTE PROFILÁTICO OU TERAPÊUTICO PARA O CÂNCER DA PRÓSTATA, AGENTE PROFILÁTICO PARA A RECORRÊNCIA PÓS-OPERATÓRIA DE CÃNCER DE MAMA PRÉ-MENOPAUSA, E, USO DA COMPOSIÇÃO DE LIBERAÇÃO PROLONGADA | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
LEUPROLIDE ACETATE Market Analysis and Financial Projection Experimental
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