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Last Updated: March 19, 2024

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 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 021964
Tradename:RELISTOR
Applicant:Salix Pharms
Ingredient:methylnaltrexone bromide
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021964
Generic Entry Date for 021964*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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: 021964
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 65649-551-02 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE
RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964 NDA Salix Pharmaceuticals, Inc. 65649-551 65649-551-03 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

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:⤷  Try a TrialPatent Expiration:Apr 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:⤷  Try a TrialPatent Expiration:Dec 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:⤷  Try a TrialPatent Expiration:Sep 30, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION

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 ⤷  Try a Trial ⤷  Try a Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.