Details for New Drug Application (NDA): 212888
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NDA 212888 describes CABENUVA KIT, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the CABENUVA KIT profile page.
The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. One supplier is listed for this compound. Additional details are available on the cabotegravir; rilpivirine profile page.
The generic ingredient in CABENUVA KIT is cabotegravir; rilpivirine. One supplier is listed for this compound. Additional details are available on the cabotegravir; rilpivirine profile page.
Summary for 212888
| Tradename: | CABENUVA KIT |
| Applicant: | Viiv Hlthcare |
| Ingredient: | cabotegravir; rilpivirine |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 212888
Generic Entry Date for 212888*:
Constraining patent/regulatory exclusivity:
Dosage:
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 212888
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888 | NDA | ViiV Healthcare Company | 49702-240 | 49702-240-15 | 1 KIT in 1 CARTON (49702-240-15) * 3 mL in 1 VIAL (49702-238-01) * 3 mL in 1 VIAL (49702-243-02) |
| CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888 | NDA | ViiV Healthcare Company | 49702-253 | 49702-253-15 | 1 KIT in 1 CARTON (49702-253-15) * 2 mL in 1 VIAL (49702-245-01) * 2 mL in 1 VIAL (49702-249-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) | ||||
| Approval Date: | Jan 21, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 21, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 31, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW DOSING SCHEDULE FOR CABOTEGRAVIR/RILPIVRINE INJECTION EVERY 2 MONTHS | ||||||||
| Regulatory Exclusivity Expiration: | Mar 29, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Expired US Patents for NDA 212888
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-001 | Jan 21, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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