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ELIGARD Drug Profile

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Eligard is a drug marketed by Tolmar Therap and is included in four NDAs. It is available from one supplier. There are four patents protecting this drug.

This drug has sixty-one patent family members in twenty-six countries.

The generic ingredient in ELIGARD 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: ELIGARD

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

Clinical Trials for: ELIGARD

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;SUBCUTANEOUS021731-001Dec 14, 2004RXYes6,565,874<disabled>Y <disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RXYes6,626,870<disabled>Y <disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 2004RXYes9,283,282<disabled>YY <disabled>
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Expired Patents for Tradename: ELIGARD

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021731-001Dec 14, 20045,278,201<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 20025,733,950<disabled>
Tolmar Therap
ELIGARD
leuprolide acetate
INJECTABLE;SUBCUTANEOUS021343-001Jan 23, 2002RE37950<disabled>
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Non-Orange Book Patents for Tradename: ELIGARD

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
9,254,307Polymeric delivery formulations of leuprolide with improved efficacy<disabled in preview>
6,143,314 Controlled release liquid delivery compositions with low initial drug burst<disabled in preview>
8,470,359Sustained release polymer<disabled in preview>
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International Patent Family for Tradename: ELIGARD

Country Document Number Estimated Expiration
Canada2348016<disabled in preview>
New Zealand525210<disabled in preview>
Denmark1267965<disabled in preview>
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