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Last Updated: July 21, 2024

METHYLNALTREXONE BROMIDE - Generic Drug Details


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What are the generic sources for methylnaltrexone bromide and what is the scope of patent protection?

Methylnaltrexone bromide is the generic ingredient in one branded drug marketed by Salix Pharms and Salix, and is included in two NDAs. There are fourteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Methylnaltrexone bromide has one hundred and thirty-seven patent family members in thirty-eight countries.

There are three drug master file entries for methylnaltrexone bromide. One supplier is listed for this compound. There are two tentative approvals for this compound.

Summary for METHYLNALTREXONE BROMIDE
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for METHYLNALTREXONE BROMIDE
Generic Entry Dates for METHYLNALTREXONE BROMIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS
Generic Entry Dates for METHYLNALTREXONE BROMIDE*:
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.

Recent Clinical Trials for METHYLNALTREXONE BROMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Alabama at BirminghamN/A
Bausch Health Americas, Inc.Phase 2/Phase 3
Karolinska University HospitalPhase 4

See all METHYLNALTREXONE BROMIDE clinical trials

Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up12MG/0.6ML SOLUTION;SUBCUTANEOUS
⤷  Sign Up⤷  Sign Up12MG/0.6MLINJECTABLE;SUBCUTANEOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for METHYLNALTREXONE BROMIDE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Paragraph IV (Patent) Challenges for METHYLNALTREXONE BROMIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RELISTOR Tablets methylnaltrexone bromide 150 mg 208271 1 2016-09-06
RELISTOR Injection methylnaltrexone bromide 8 mg/0.4 mL 021964 1 2015-09-08
RELISTOR Injection methylnaltrexone bromide 12 mg/0.6 mL 021964 1 2015-07-22

US Patents and Regulatory Information for METHYLNALTREXONE BROMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for METHYLNALTREXONE BROMIDE

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

EU/EMA Drug Approvals for METHYLNALTREXONE BROMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Bausch Health Ireland Limited Relistor methylnaltrexone bromide EMEA/H/C/000870
Treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
Authorised no no no 2008-07-01
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for METHYLNALTREXONE BROMIDE

Country Patent Number Title Estimated Expiration
Israel 211865 אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof) ⤷  Sign Up
Spain 2528669 ⤷  Sign Up
Chile 2012002192 Sal de metilnaltrexona cuyo anión es un excipiente anfifílico; composición farmacéutica para administración oral que comprende esta sal y un excipiente anfifílico; método de preparación de la composición farmaceutica; método para reducir efectos secundarios de la terapia opioide; producto; y paquete multidía. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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