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Last Updated: March 29, 2024

METHYLNALTREXONE BROMIDE - Generic Drug Details


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What are the generic sources for methylnaltrexone bromide and what is the scope of freedom to operate?

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
⤷  Try a Trial⤷  Try a Trial12MG/0.6ML SOLUTION;SUBCUTANEOUS
⤷  Try a Trial⤷  Try a Trial12MG/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 021964-001 Apr 24, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-003 Sep 27, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 021964-002 Sep 27, 2010 ⤷  Try a Trial ⤷  Try a Trial
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 ⤷  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

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
Costa Rica 20120476 FORMULACIONES ORALES Y SALES LIPOFÍLICAS DE METILNALTREXONA ⤷  Try a Trial
Japan 6429955 ⤷  Try a Trial
Portugal 1615646 ⤷  Try a Trial
Israel 211865 אנטאגוניסטים לקולטן חיצוני של אופיואיד ושימושיהם (Peripheral opioid receptor antagonists and uses thereof) ⤷  Try a Trial
Singapore 194393 PERIPHERAL OPIOID RECEPTOR ANTAGONISTS AND USES THEREOF ⤷  Try a Trial
Australia 2013203378 Pharmaceutical formulations containing methylnaltrexone ⤷  Try a Trial
Poland 2368554 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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