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Last Updated: January 30, 2023

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-six 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
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
See Plans and PricingSee Plans and Pricing12MG/0.6ML SOLUTION;SUBCUTANEOUS
See Plans and PricingSee Plans and Pricing12MG/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 Action Opioid 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 021964-003 Sep 27, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-002 Sep 27, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Salix Pharms RELISTOR methylnaltrexone bromide SOLUTION;SUBCUTANEOUS 021964-001 Apr 24, 2008 See Plans and Pricing See Plans and Pricing
Salix RELISTOR methylnaltrexone bromide TABLET;ORAL 208271-001 Jul 19, 2016 See Plans and Pricing See Plans and Pricing
>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
Hong Kong 1082181 包含甲基納曲酮的藥劑程式 (PHARMACEUTICAL FORMULATIONS CONTAINING METHYLNALTREXONE) See Plans and Pricing
Japan 5719773 See Plans and Pricing
Poland 2368554 See Plans and Pricing
European Patent Office 2371357 Formulations orales et sels lipophiles de la méthylnaltrexone (Oral formulations and lipophilic salts of methylnaltrexone) See Plans and Pricing
Hungary E033133 See Plans and Pricing
Colombia 6630134 Formulación orales y sales lipofílicas de metilnaltrexona See Plans and Pricing
Japan 2019034958 メチルナルトレキソンの経口製剤および親油性塩 (ORAL FORMULATIONS AND LIPOPHILIC SALTS OF METHYLNALTREXONE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
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Moodys
Dow
Mallinckrodt

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