Details for New Drug Application (NDA): 212887
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The generic ingredient in VOCABRIA is cabotegravir sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabotegravir sodium profile page.
Summary for 212887
| Tradename: | VOCABRIA |
| Applicant: | Viiv Hlthcare |
| Ingredient: | cabotegravir sodium |
| Patents: | 2 |
Suppliers and Packaging for NDA: 212887
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887 | NDA | ViiV Healthcare Company | 49702-248 | 49702-248-13 | 30 TABLET, FILM COATED in 1 BOTTLE (49702-248-13) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
| Approval Date: | Jan 21, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,927,129 | Patent Expiration: | Apr 28, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,410,103 | Patent Expiration: | Feb 4, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV-1 INFECTION IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 35 KG | ||||||||
Expired US Patents for NDA 212887
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | VOCABRIA | cabotegravir sodium | TABLET;ORAL | 212887-001 | Jan 21, 2021 | 10,927,129 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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