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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Cerilliant
Boehringer Ingelheim
McKinsey
Citi
Farmers Insurance
Moodys
Queensland Health
Harvard Business School

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021964

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NDA 021964 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 021964
Tradename:RELISTOR
Applicant:Salix Pharms
Ingredient:methylnaltrexone bromide
Patents:7
Pharmacology for NDA: 021964
Ingredient-typeQuaternary Ammonium Compounds
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 021964
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964 NDA Salix Pharmaceuticals, Inc. 65649-551 N 65649-551-02
RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964 NDA Salix Pharmaceuticals, Inc. 65649-551 N 65649-551-07

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength12MG/0.6ML (12MG/0.6ML)
Approval Date:Apr 24, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:➤ Sign UpPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:➤ Sign UpPatent Expiration:Apr 8, 2024Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 021964

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 ➤ Sign Up ➤ Sign Up
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Daiichi Sankyo
Federal Trade Commission
Colorcon
Harvard Business School
Citi
UBS
Argus Health
Fish and Richardson

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