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Leuprolide acetate - Generic Drug Details

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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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and twenty-three patent family members in forty-four countries.

There are twenty drug master file entries for leuprolide acetate. Eight suppliers are listed for this compound.

Summary for Generic Name: leuprolide acetate

Tradenames:7
Patents:18
Applicants:8
NDAs:16
Drug Master File Entries: see list20
Suppliers / Packaging: see list8
Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: leuprolide acetate

Clinical Trials for: leuprolide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 2002RXYes6,565,874<disabled>Y <disabled>
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-005Jan 21, 1994RXYes6,036,976<disabled> <disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYes6,773,714<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: leuprolide acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-002Apr 16, 19935,575,987<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021379-001Jul 24, 20024,938,763<disabled>
Abbvie Endocrine Inc
LUPRON DEPOT-PED
leuprolide acetate
INJECTABLE;INJECTION020263-006Jan 21, 19944,005,063<disabled>
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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
6,630,155 Controlled release liquid delivery compositions with low initial drug burst<disabled in preview>
9,254,307Polymeric delivery formulations of leuprolide with improved efficacy<disabled in preview>
8,067,030Controlled release composition and method of producing the same<disabled in preview>
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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
European Patent Office0921808<disabled in preview>
Czech Republic9802365<disabled in preview>
China100577206<disabled in preview>
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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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