Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 13, 2019

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 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
Generic Entry Opportunity 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
Paragraph IV (Patent) Challenges for 021964
Tradename Dosage Ingredient NDA Submissiondate
RELISTOR SOLUTION;SUBCUTANEOUS methylnaltrexone bromide 021964 2015-09-08

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:  Start TrialPatent Expiration:Apr 8, 2024Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:  Start TrialPatent Expiration:Dec 31, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF OPIOID-INDUCED CONSTIPATION
Patent:  Start 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   Start Trial   Start Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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