Details for New Drug Application (NDA): 210136
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NDA 210136 describes BRIXADI, which is a drug marketed by Braeburn and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the BRIXADI profile page.
The generic ingredient in BRIXADI is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
The generic ingredient in BRIXADI is buprenorphine. There are twenty-nine drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 210136
| Tradename: | BRIXADI |
| Applicant: | Braeburn |
| Ingredient: | buprenorphine |
| Patents: | 7 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210136
| Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 210136
Suppliers and Packaging for NDA: 210136
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136 | NDA | Braeburn Inc. | 58284-208 | 58284-208-01 | 1 SYRINGE, GLASS in 1 CARTON (58284-208-01) / .16 mL in 1 SYRINGE, GLASS |
| BRIXADI | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 210136 | NDA | Braeburn Inc. | 58284-216 | 58284-216-01 | 1 SYRINGE, GLASS in 1 CARTON (58284-216-01) / .32 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 8MG/0.16ML (50MG/ML) | ||||
| Approval Date: | May 23, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 23, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 26, 2032 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE. A METHOD OF TREATING OPIOID WITHDRAWAL USING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 26, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | A METHOD OF ADMINISTERING AN OPIOID MAINTENANCE TREATMENT COMPRISING BUPRENORPHINE | ||||||||
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