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Generated: May 29, 2017

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LEUPROLIDE ACETATE - Generic Drug Details

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What are the generic drug sources for leuprolide acetate and what is the scope of leuprolide acetate patent protection?

Leuprolide acetate
is the generic ingredient in seven branded drugs marketed by Abbvie Endocrine Inc, Genzyme, Sandoz, Tolmar Therap, Teva Pharms Usa, Sun Pharma Global, Ortho Mcneil Janssen, and Abbvie Endocrine, and is included in sixteen NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Leuprolide acetate has three hundred and thirty patent family members in forty-four countries.

There are twenty-one drug master file entries for leuprolide acetate. Six suppliers are listed for this compound.

Summary for Generic Name: LEUPROLIDE ACETATE

Drug Master File Entries: see list21
Suppliers / Packagers: see list6
Bulk Api Vendors: see list38
Clinical Trials: see list469
Patent Applications: see list9,692
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:LEUPROLIDE ACETATE at DailyMed

Pharmacology for Ingredient: 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
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYesYes9,539,333► SubscribeYY ► Subscribe
Ortho Mcneil Janssen
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNoNo5,728,396► Subscribe ► Subscribe
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020517-003Jun 17, 2011RXYesNo8,815,801► SubscribeY ► Subscribe
Abbvie Endocrine Inc
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 1990DISCNYesNo► Subscribe► Subscribe
Sun Pharma Global
leuprolide acetate
INJECTABLE;INJECTION078885-001Mar 9, 2009APRXNoNo► Subscribe► Subscribe
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