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Last Updated: November 21, 2024

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.
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:RXDosage:SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength400MG/2ML (200MG/ML);600MG/2ML (300MG/ML)
Approval Date:Jan 21, 2021TE: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.