Details for New Drug Application (NDA): 208271
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The generic ingredient in RELISTOR 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.
Summary for 208271
Tradename: | RELISTOR |
Applicant: | Salix |
Ingredient: | methylnaltrexone bromide |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208271
Generic Entry Date for 208271*:
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.
Pharmacology for NDA: 208271
Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 208271
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271 | NDA | Salix Pharmaceuticals, Inc. | 65649-150 | 65649-150-06 | 1 BOTTLE in 1 CARTON (65649-150-06) / 6 TABLET in 1 BOTTLE |
RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271 | NDA | Salix Pharmaceuticals, Inc. | 65649-150 | 65649-150-90 | 90 TABLET in 1 BOTTLE (65649-150-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
Approval Date: | Jul 19, 2016 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 10, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Sep 30, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION |
Expired US Patents for NDA 208271
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix | RELISTOR | methylnaltrexone bromide | TABLET;ORAL | 208271-001 | Jul 19, 2016 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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