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Methylnaltrexone bromideis 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 twenty-nine patent family members in thirty-seven countries.
There are three drug master file entries for methylnaltrexone bromide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for methylnaltrexone bromide
|Drug Master File Entries:||3|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||32|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for methylnaltrexone bromide|
|What excipients (inactive ingredients) are in methylnaltrexone bromide?||methylnaltrexone bromide excipients list|
|DailyMed Link:||methylnaltrexone bromide at DailyMed|
Recent Clinical Trials for methylnaltrexone bromide
Identify potential brand extensions & 505(b)(2) entrants
|University of Alabama at Birmingham||N/A|
|Bausch Health Americas, Inc.||Phase 3|
|Bausch Health Americas, Inc.||Phase 2/Phase 3|
Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE
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 Class||Opioid Antagonist |
|Mechanism of Action||Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for methylnaltrexone bromide
Paragraph IV (Patent) Challenges 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||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Salix Pharms||RELISTOR||methylnaltrexone bromide||SOLUTION;SUBCUTANEOUS||021964-001||Apr 24, 2008||⤷ Free Forever Trial||⤷ Free Forever Trial|
|Salix||RELISTOR||methylnaltrexone bromide||TABLET;ORAL||208271-001||Jul 19, 2016||⤷ Free Forever Trial||⤷ Free Forever Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Country||Patent Number||Estimated Expiration|
|Mexico||PA05010817||⤷ Free Forever Trial|
|Hong Kong||1199442||⤷ Free Forever Trial|
|China||104383542||⤷ Free Forever Trial|
|Japan||2016029054||⤷ Free Forever Trial|
|Japan||6647368||⤷ Free Forever Trial|
|Canada||2676881||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated 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.