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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Colorcon
Mallinckrodt
Covington
Cipla
Cantor Fitzgerald
Daiichi Sankyo
Chubb
AstraZeneca

Generated: June 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208271

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NDA 208271 describes RELISTOR, which is a drug marketed by Salix Pharms and Salix Pharms Inc and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and three Paragraph IV challenges. Additional details are available on the RELISTOR profile page.

The generic ingredient in RELISTOR is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.
Summary for 208271
Tradename:RELISTOR
Applicant:Salix Pharms Inc
Ingredient:methylnaltrexone bromide
Patents:7
Pharmacology for NDA: 208271
Ingredient-typeQuaternary Ammonium Compounds
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 208271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RELISTOR methylnaltrexone bromide TABLET;ORAL 208271 NDA Salix Pharmaceuticals, Inc. 65649-150 N 65649-150-06
RELISTOR methylnaltrexone bromide TABLET;ORAL 208271 NDA Salix Pharmaceuticals, Inc. 65649-150 N 65649-150-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 19, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Try a Free TrialPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:➤ Try a Free TrialPatent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

McKinsey
Harvard Business School
Johnson and Johnson
Covington
Daiichi Sankyo
Fuji
McKesson
Healthtrust
Cantor Fitzgerald

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