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LUPRON DEPOT Drug Profile

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Lupron Depot is a drug marketed by Abbvie Endocrine Inc and is included in five NDAs. It is available from one supplier. There are four patents protecting this drug.

This drug has one hundred and five patent family members in forty-one countries.

The generic ingredient in LUPRON DEPOT is leuprolide acetate. There are twenty drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the leuprolide acetate profile page.

Summary for Tradename: LUPRON DEPOT

Patents:4
Applicants:1
NDAs:5
Suppliers / Packagers: see list1

Clinical Trials for: LUPRON DEPOT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020708-001Mar 7, 1997RXYes6,036,976<disabled> <disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-003Jun 17, 2011RXNo6,036,976<disabled>Y <disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-001Dec 22, 1995RXYes6,036,976<disabled> <disabled>
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Expired Patents for Tradename: LUPRON DEPOT

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020517-001Dec 22, 19955,631,020<disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 19905,575,987<disabled>
Abbvie Endocrine Inc
LUPRON DEPOT
leuprolide acetate
INJECTABLE;INJECTION020011-001Oct 22, 19905,716,640<disabled>
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Non-Orange Book Patents for Tradename: LUPRON DEPOT

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
5,851,451 Production of microspheres<disabled in preview>
8,246,987Controlled release composition and method of producing the same<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 Tradename: LUPRON DEPOT

Country Document Number Estimated Expiration
Norway20092662<disabled in preview>
Georgia, Republic ofP20125597<disabled in preview>
Japan2009167203<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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