Details for New Drug Application (NDA): 212887
✉ Email this page to a colleague
The generic ingredient in VOCABRIA is cabotegravir sodium. 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 |
Complete Access Available with Subscription
