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Last Updated: March 19, 2024

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 Loss of Exclusivity (LOE) Date for 208271
Generic Entry Date for 208271*:
Constraining patent/regulatory exclusivity:
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 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
Patent:⤷  Try a TrialPatent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Mar 10, 2031Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION

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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 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.