Details for New Drug Application (NDA): 209819
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NDA 209819 describes SUBLOCADE, which is a drug marketed by Indivior and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the SUBLOCADE profile page.
The generic ingredient in SUBLOCADE is buprenorphine. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
The generic ingredient in SUBLOCADE is buprenorphine. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the buprenorphine profile page.
Summary for 209819
| Tradename: | SUBLOCADE |
| Applicant: | Indivior |
| Ingredient: | buprenorphine |
| Patents: | 13 |
Pharmacology for NDA: 209819
| Mechanism of Action | Partial Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 209819
Suppliers and Packaging for NDA: 209819
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SUBLOCADE | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 209819 | NDA | Indivior Inc. | 12496-0100 | 12496-0100-1 | 1 POUCH in 1 CARTON (12496-0100-1) / 1 SYRINGE in 1 POUCH (12496-0100-2) / 1 SOLUTION in 1 SYRINGE (12496-0100-5) |
| SUBLOCADE | buprenorphine | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | 209819 | NDA | Indivior Inc. | 12496-0300 | 12496-0300-1 | 1 POUCH in 1 CARTON (12496-0300-1) / 1 SYRINGE in 1 POUCH (12496-0300-2) / 1 SOLUTION in 1 SYRINGE (12496-0300-5) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS | Strength | 100MG/0.5ML (100MG/0.5ML) | ||||
| Approval Date: | Nov 30, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 21, 2028 | ||||||||
| Regulatory Exclusivity Use: | UPDATES TO THE PRESCRIBING INFORMATION BASED ON RESULTS OF CLINICAL STUDIES | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 6, 2031 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE TO SEVERE OPIOID USE DISORDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jun 25, 2031 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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