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 and is included in two NDAs. It is available from one supplier. There are fourteen 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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for 208271

Generic Entry Date for 208271^: See Plans and Pricing* Constraining patent/regulatory exclusivity: See Plans and Pricing Dosage: TABLET;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: 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:	See Plans and Pricing	Patent Expiration:	Mar 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Mar 10, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	See Plans and Pricing	Patent Expiration:	Sep 30, 2029	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF OPIOID-INDUCED CONSTIPATION

Expired US Patents for NDA 208271

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix	RELISTOR	methylnaltrexone bromide	TABLET;ORAL	208271-001	Jul 19, 2016	See Plans and Pricing	See Plans and Pricing
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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