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ENTEREG Drug Profile

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Which patents cover Entereg, and what substitute generic drugs are available?

Entereg is a drug marketed by Cubist Pharms and is included in one NDA. There are four patents protecting this drug.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in ENTEREG is alvimopan. There are four 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:4
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list75
Clinical Trials: see list11
Patent Applications: see list317
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ENTEREG at DailyMed

Pharmacology for Tradename: ENTEREG

Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes6,469,030► Subscribe ► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes8,946,262► Subscribe ► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes8,645,160► Subscribe ► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes8,112,290► Subscribe ► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008RXYesYes► Subscribe► Subscribe
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Expired Patents for Tradename: ENTEREG

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 20085,250,542► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 20085,434,171► Subscribe
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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► 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 Tradename: ENTEREG

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2005055953► Subscribe
Japan5460771► Subscribe
Portugal1244448► Subscribe
Canada2393141► Subscribe
MexicoPA02005336► 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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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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