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ENTEREG Drug Profile

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Entereg is a drug marketed by Cubist Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug.

This drug has fifty patent family members in twenty-eight countries.

The generic ingredient in ENTEREG is alvimopan. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alvimopan profile page.

Summary for Tradename: ENTEREG

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

Pharmacology for Tradename: ENTEREG

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

Clinical Trials for: ENTEREG

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYes5,250,542<disabled>YY <disabled>
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYes8,112,290<disabled> <disabled>
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYes6,469,030<disabled> <disabled>
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Expired Patents for Tradename: ENTEREG

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 20085,250,542<disabled>
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 20085,434,171<disabled>
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Non-Orange Book Patents for Tradename: ENTEREG

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
7,696,220Methods for the treatment or inhibition of ileus<disabled in preview>
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International Patent Family for Tradename: ENTEREG

Country Document Number Estimated Expiration
New Zealand518684<disabled in preview>
European Patent Office1244448<disabled in preview>
Israel101382<disabled in preview>
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