Details for New Drug Application (NDA): 208271

✉ Email this page to a colleague

NDA 208271 describes RELISTOR, which is a drug marketed by Salix Pharms and Salix and is included in two NDAs. It is available from one supplier. There are twelve 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
Ingredient:	methylnaltrexone bromide
Patents:	9

Pharmacology for NDA: 208271

Mechanism of Action	Opioid 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	65649-150-06	1 BOTTLE in 1 CARTON (65649-150-06) / 6 TABLET in 1 BOTTLE
RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271	NDA	Salix Pharmaceuticals, Inc.	65649-150	65649-150-90	90 TABLET in 1 BOTTLE (65649-150-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	150MG
Approval Date:	Jul 19, 2016	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Get Started Free	Patent Expiration:	Sep 30, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 208271

Subscribe to access the full database, or Get Started Free
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.