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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 021775

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NDA 021775 describes ENTEREG, which is a drug marketed by Cubist Pharms and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ENTEREG profile page.

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

Summary for 021775

Tradename:	ENTEREG
Applicant:	Cubist Pharms
Ingredient:	alvimopan
Patents:	1
Formulation / Manufacturing:	see details

Pharmacology for NDA: 021775

Mechanism of Action	Opioid Antagonists

Suppliers and Packaging for NDA: 021775

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ENTEREG	alvimopan	CAPSULE;ORAL	021775	NDA	Merck Sharp & Dohme LLC	67919-020	67919-020-10	6 BLISTER PACK in 1 CARTON (67919-020-10) / 5 CAPSULE in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	12MG
Approval Date:	May 20, 2008	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Feb 12, 2030	Product Flag?		Substance Flag?		Delist Request?
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

Expired US Patents for NDA 021775

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

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