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Last Updated: May 13, 2021

DrugPatentWatch Database Preview

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 Generic Entry Opportunity 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 * 3 mL in 1 VIAL
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 * 2 mL in 1 VIAL

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:
Patent:  Get Started for $10Patent Expiration:Apr 28, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:  Get Started for $10Patent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?YDelist Request?

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 212888-002 Jan 21, 2021   Get Started for $10   Get Started for $10
Viiv Hlthcare CABENUVA KIT cabotegravir; rilpivirine SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212888-001 Jan 21, 2021   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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