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Serving leading biopharmaceutical companies globally:

Accenture
Cantor Fitzgerald
UBS
Johnson and Johnson
US Department of Justice
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Federal Trade Commission
Cerilliant
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Generated: November 18, 2017

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:
1
Applicant:
1
Ingredient:
1
Patents:4
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
Regulatory Exclusivity Expiration:Oct 18, 2016
Regulatory Exclusivity Use:CLINICAL TRIAL STUDY RESULTS
Patent:► SubscribePatent Expiration:Nov 29, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING OR PREVENTING ILEUS
Patent:► SubscribePatent Expiration:Jul 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS

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, 2008► Subscribe► Subscribe
Cubist Pharms
ENTEREG
alvimopan
CAPSULE;ORAL021775-001May 20, 2008► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
QuintilesIMS
UBS
Covington
Baxter
Chinese Patent Office
Fish and Richardson
Accenture
Federal Trade Commission
Medtronic

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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