ENTEREG Drug Patent Profile

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When do Entereg patents expire, and what generic alternatives are available?

Entereg is a drug marketed by Cubist Pharms and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has one patent family member in one country.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Entereg

A generic version of ENTEREG was approved as alvimopan by WATSON LABS TEVA on December 19^th, 2019.

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Summary for ENTEREG

International Patents:	1
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	16
Patent Applications:	818
Drug Prices:	Drug price information for ENTEREG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENTEREG
What excipients (inactive ingredients) are in ENTEREG?	ENTEREG excipients list
DailyMed Link:	ENTEREG at DailyMed

Drug patent expirations by year for ENTEREG

Recent Clinical Trials for ENTEREG

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
The Cleveland Clinic	Phase 4
Scott Steele	Phase 4
Brigham and Women's Hospital	Phase 3

See all ENTEREG clinical trials

Paragraph IV (Patent) Challenges for ENTEREG

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ENTEREG	Capsules	alvimopan	12 mg	021775	1	2017-06-16

US Patents and Regulatory Information for ENTEREG

ENTEREG is protected by one US patents.

Patents protecting ENTEREG

Methods of preventing and treating gastrointestinal dysfunction
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: A METHOD TO ACCELERATE THE TIME TO GASTROINTESTINAL RECOVERY BY ADMINISTERING ABOUT 12 MG OF ALVIMOPAN TO THE PATIENT FROM ABOUT 30 TO 60 MINUTES PRIOR TO SURGERY

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for ENTEREG

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	⤷ Sign Up	⤷ Sign Up
Cubist Pharms	ENTEREG	alvimopan	CAPSULE;ORAL	021775-001	May 20, 2008	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for ENTEREG

See the table below for patents covering ENTEREG around the world.

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2005055953		⤷ Sign Up
Japan	5460771		⤷ Sign Up
Hungary	T71489		⤷ Sign Up
European Patent Office	0506478	Dérivés de la pipéridine (Piperidine derivatives)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration