METHYLNALTREXONE BROMIDE Drug Patent Profile
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When do Methylnaltrexone Bromide patents expire, and when can generic versions of Methylnaltrexone Bromide launch?
Methylnaltrexone Bromide is a drug marketed by Actavis Llc and is included in one NDA.
The generic ingredient in METHYLNALTREXONE BROMIDE is methylnaltrexone bromide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the methylnaltrexone bromide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Methylnaltrexone Bromide
A generic version of METHYLNALTREXONE BROMIDE was approved as methylnaltrexone bromide by ACTAVIS LLC on August 26th, 2024.
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Summary for METHYLNALTREXONE BROMIDE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 17 |
| Patent Applications: | 1,174 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for METHYLNALTREXONE BROMIDE |
| 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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Llc | METHYLNALTREXONE BROMIDE | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 208112-001 | Aug 26, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Actavis Llc | METHYLNALTREXONE BROMIDE | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 208112-002 | Aug 26, 2024 | AP | RX | No | No | ⤷ 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 |
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 |
