Details for New Drug Application (NDA): 212888
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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 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
Viiv Hlthcare | CABENUVA KIT | cabotegravir; rilpivirine | SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 212888-002 | Jan 21, 2021 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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