Details for New Drug Application (NDA): 021964
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NDA 021964 describes RELISTOR, which is a drug marketed by Salix Pharms and Salix and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug and three Paragraph IV challenges. Additional details are available on the RELISTOR profile page.
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.
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: | 6 |
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: | 12,303,592 | Patent Expiration: | Aug 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF OIC IN ADULTS WITH ADVANCED ILLNESS OR PAIN CAUSED BY ACTIVE CANCER WHO REQUIRE OPIOID DOSAGE ESCALATION FOR PALLIATIVE CARE | ||||||||
| Patent: | 12,303,592 | Patent Expiration: | Aug 3, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC NON-CANCER PAIN, INCLUDING PATIENTS WITH CHRONIC PAIN RELATED TO PRIOR CANCER OR ITS TREATMENT WHO DO NOT REQUIRE FREQUENT (E.G., WEEKLY) OPIOID DOSAGE ESCALATION | ||||||||
| Patent: | 8,247,425 | Patent Expiration: | Dec 31, 2030 | 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 | 021964-003 | Sep 27, 2010 | 9,669,096 | ⤷ Get Started Free |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-002 | Sep 27, 2010 | 10,376,584 | ⤷ Get Started Free |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 8,552,025 | ⤷ Get Started Free |
| Salix Pharms | RELISTOR | methylnaltrexone bromide | SOLUTION;SUBCUTANEOUS | 021964-001 | Apr 24, 2008 | 9,669,096 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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