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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 are five patents protecting this drug. 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. One supplier is listed for this compound. Additional details are available on the alvimopan profile page.

Summary for NDA: 021775

Tradename:
ENTEREG
Applicant:
Cubist Pharms
Ingredient:
alvimopan
Patents:5
Formulation / Manufacturing:see details

Pharmacology for NDA: 021775

Mechanism of ActionOpioid 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 Corp. 67919-020 67919-020-10 6 BLISTER PACK in 1 CARTON (67919-020-10) > 5 CAPSULE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength12MG
Approval Date:May 20, 2008TE:RLD:Yes
Patent:5,250,542Patent Expiration:Mar 29, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR
Patent:6,469,030Patent Expiration:Nov 29, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING OR PREVENTING ILEUS
Patent:8,946,262Patent Expiration:Feb 12, 2030Product 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 Orange Book Patents for NDA: 021775

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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