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Generated: January 22, 2019

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
Applicant:Salix Pharms Inc
Ingredient:methylnaltrexone bromide
Generic Entry Opportunity Date for 208271
Generic Entry Date for 208271*:
Constraining patent/regulatory exclusivity:

*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 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 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:RXDosage:TABLET;ORALStrength150MG
Approval Date:Jul 19, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 19, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?

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