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Serving 500+ biopharmaceutical companies globally:

McKesson
Accenture
Cerilliant
Daiichi Sankyo
Federal Trade Commission
Cipla
Chubb
Citi
Covington
US Army

Generated: September 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 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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for Generic Name: leuprolide acetate

Tradenames:7
Patents:23
Applicants:8
NDAs:16
Drug Master File Entries: see list21
Suppliers / Packagers: see list5
Bulk Api Vendors: see list38
Clinical Trials: see list996
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
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION019732-001Jan 26, 1989RXYesYes► Subscribe► Subscribe ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYesYes► Subscribe► SubscribeY ► Subscribe
Abbvie Endocrine Inc
LUPRON
leuprolide acetate
INJECTABLE;INJECTION019010-001Apr 9, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-007Aug 15, 2011RXYesYes► Subscribe► SubscribeY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYesYes► Subscribe► SubscribeYY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYesYes► Subscribe► SubscribeY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► SubscribeYY ► Subscribe
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYesYes► Subscribe► SubscribeYY ► Subscribe
Sun Pharma Global
LEUPROLIDE ACETATE
leuprolide acetate
INJECTABLE;INJECTION078885-001Mar 9, 2009APRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: leuprolide acetate

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
6,143,314 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
6,261,584 Sustained delivery of an active agent using an implantable system► Subscribe
7,655,257Sustained delivery of an active agent using an implantable system► Subscribe
8,535,701Sustained delivery of an active agent using an implantable system► Subscribe
6,630,155 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
5,851,451 Production of microspheres► Subscribe
6,635,268 Sustained delivery of an active agent using an implantable system► Subscribe
8,246,987Controlled release composition and method of producing the same► Subscribe
8,067,030Controlled release composition and method of producing the same► Subscribe
8,080,259Sustained delivery of an active agent using an implantable system► 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
South Korea20040018402► Subscribe
China1210459► Subscribe
Portugal1126822► Subscribe
European Patent Office1586309► Subscribe
European Patent Office0779072► Subscribe
Israel127771► Subscribe
Norway322514► Subscribe
Spain2191165► Subscribe
European Patent Office1142567► Subscribe
World Intellectual Property Organization (WIPO)9727840► 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:

Teva
Johnson and Johnson
Healthtrust
Medtronic
QuintilesIMS
Covington
Mallinckrodt
Dow
Julphar
Chubb

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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