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 two branded drugs marketed by Actavis Llc, Salix Pharms, and Salix, and is included in three 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
International Patents: | 137 |
US Patents: | 14 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 51 |
Clinical Trials: | 17 |
Patent Applications: | 428 |
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
Sponsor | Phase |
---|---|
University of Alabama at Birmingham | N/A |
Bausch Health Americas, Inc. | Phase 2/Phase 3 |
Karolinska University Hospital | Phase 4 |
Generic filers with tentative approvals for METHYLNALTREXONE BROMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 12MG/0.6ML | SOLUTION;SUBCUTANEOUS |
⤷ Sign Up | ⤷ Sign Up | 12MG/0.6ML | INJECTABLE;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 Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for methylnaltrexone bromide
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, Single Dose Prefilled Syringe | 021964 | 1 | 2015-09-08 |
RELISTOR | Injection | methylnaltrexone bromide | 12 mg/0.6 mL, Single Dose Vial | 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 | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | 021964-002 | Sep 27, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-003 | Sep 27, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | ⤷ 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 |
---|---|---|---|
Japan | 6647368 | ⤷ Sign Up | |
Colombia | 6630134 | Formulación orales y sales lipofílicas de metilnaltrexona | ⤷ Sign Up |
Poland | 3608322 | ⤷ Sign Up | |
Australia | 2009298500 | Peripheral opioid receptor antagonists and uses thereof | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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