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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Accenture
Boehringer Ingelheim
Teva
Merck
US Department of Justice
Cantor Fitzgerald
UBS
Covington
Harvard Business School

Generated: June 23, 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 freedom to operate?

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-one 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

Tradenames:7
Patents:24
Applicants:8
NDAs:16
Drug Master File Entries: see list21
Suppliers / Packagers: see list6
Bulk Api Vendors: see list38
Clinical Trials: see list972
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
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes8,840,916► SubscribeY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes6,626,870► SubscribeY ► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-007Aug 15, 2011RXYesYes6,036,976► SubscribeY ► Subscribe
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNoNo6,156,331► Subscribe ► Subscribe
Ortho Mcneil Janssen
VIADUR
leuprolide acetate
IMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNoNo6,235,712► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020708-001Mar 7, 19974,728,721► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-001Dec 22, 19955,814,342► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 20034,938,763► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-002May 30, 19975,330,767► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-002May 30, 19975,480,656► Subscribe
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Non-Orange Book Patents for Generic Ingredient: leuprolide acetate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,067,030Controlled release composition and method of producing the same► Subscribe
8,535,701Sustained delivery of an active agent using an implantable system► Subscribe
5,851,451 Production of microspheres► Subscribe
6,261,584 Sustained delivery of an active agent using an implantable system► Subscribe
8,246,987Controlled release composition and method of producing the same► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: leuprolide acetate

Country Document Number Estimated Expiration
Costa Rica11283► Subscribe
Japan2014240439► Subscribe
Austria509668► Subscribe
Chile2007003658► Subscribe
Brazil9710132► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Novartis
Merck
UBS
Medtronic
Covington
Citi
Cantor Fitzgerald
Teva
Fuji
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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