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Generated: November 21, 2018

DrugPatentWatch Database Preview

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 four patents 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. One supplier is listed for this compound. Additional details are available on the alvimopan profile page.
Summary for 021775
Tradename:ENTEREG
Applicant:Cubist Pharms
Ingredient:alvimopan
Patents:4
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021775
Generic Entry Date for 021775*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength12MG
Approval Date:May 20, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Nov 29, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING OR PREVENTING ILEUS
Patent:➤ Try a Free TrialPatent Expiration:Jul 31, 2030Product Flag?Substance Flag?Delist Request?Y
Patented Use:ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
Patent:➤ Try a Free TrialPatent Expiration:Jun 18, 2029Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS

Expired US Patents for NDA 021775

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

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Serving hundreds of leading biopharmaceutical companies globally:

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