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Serving leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
UBS
Fish and Richardson
Healthtrust
QuintilesIMS
Cerilliant
Teva
Moodys
Daiichi Sankyo

Generated: December 11, 2017

DrugPatentWatch Database Preview

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 Ortho Mcneil Janssen, Genzyme, Sandoz, Sun Pharma Global, Teva Pharms Usa, Abbvie Endocrine Inc, Tolmar Therap, 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 seventy-one 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.

Pharmacology for leuprolide acetate

Medical Subject Heading (MeSH) Categories for leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION020517-001Dec 22, 1995RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Tolmar TherapELIGARDleuprolide acetateINJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-007Aug 15, 2011RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Tolmar TherapELIGARDleuprolide acetateINJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION020011-002Oct 26, 1995RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-003Apr 16, 1993DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Ortho Mcneil JanssenVIADURleuprolide acetateIMPLANT;IMPLANTATION021088-001Mar 3, 2000DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Tolmar TherapELIGARDleuprolide acetateINJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-002Apr 16, 1993RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Tolmar TherapELIGARDleuprolide acetateINJECTABLE;SUBCUTANEOUS021488-001Feb 13, 2003RXYesYes► Subscribe► Subscribe► SubscribeY► 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 IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-002Apr 16, 1993► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-002Apr 16, 1993► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-002Apr 16, 1993► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION020517-002May 30, 1997► Subscribe► Subscribe
Ortho Mcneil JanssenVIADURleuprolide acetateIMPLANT;IMPLANTATION021088-001Mar 3, 2000► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOT-PEDleuprolide acetateINJECTABLE;INJECTION020263-005Jan 21, 1994► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION019732-001Jan 26, 1989► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION020517-002May 30, 1997► Subscribe► Subscribe
Tolmar TherapELIGARDleuprolide acetateINJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002► Subscribe► Subscribe
Abbvie Endocrine IncLUPRON DEPOTleuprolide acetateINJECTABLE;INJECTION019732-001Jan 26, 1989► Subscribe► 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
6,143,314 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
8,067,030Controlled release composition and method of producing the same► Subscribe
8,246,987Controlled release composition and method of producing the same► Subscribe
6,261,584 Sustained delivery of an active agent using an implantable system► Subscribe
9,713,595Sustained-release composition and method for producing the same► Subscribe
6,630,155 Controlled release liquid delivery compositions with low initial drug burst► Subscribe
8,535,701Sustained delivery of an active agent using an implantable system► Subscribe
8,080,259Sustained delivery of an active agent using an implantable system► Subscribe
8,298,562Sustained delivery of an active agent using an implantable system► Subscribe
9,617,303Sustained-release composition and method for 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
Hungary0400378► Subscribe
China1146403► Subscribe
Japan6087886► Subscribe
Israel155006► Subscribe
Argentina007714► Subscribe
Taiwan381033► Subscribe
Taiwan584562► Subscribe
Hong Kong1139596► Subscribe
Germany69836149► Subscribe
South Korea100576583► 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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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Citi
Fish and Richardson
US Army
Chubb
Accenture
Mallinckrodt
Express Scripts
Harvard Business School

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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