Details for New Drug Application (NDA): 021964
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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 021964
Tradename: | RELISTOR |
Applicant: | Salix Pharms |
Ingredient: | methylnaltrexone bromide |
Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021964
Generic Entry Date for 021964*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 021964
Mechanism of Action | Opioid Antagonists |
Suppliers and Packaging for NDA: 021964
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964 | NDA | Salix Pharmaceuticals, Inc. | 65649-551 | 65649-551-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (65649-551-02) / .6 mL in 1 VIAL, SINGLE-DOSE |
RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964 | NDA | Salix Pharmaceuticals, Inc. | 65649-551 | 65649-551-03 | 7 BLISTER PACK in 1 CARTON (65649-551-03) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 12MG/0.6ML (12MG/0.6ML) | ||||
Approval Date: | Apr 24, 2008 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 8, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 31, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Sep 30, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION |
Expired US Patents for NDA 021964
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
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