Last Updated: September 24, 2026

Details for New Drug Application (NDA): 215499

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NDA 215499 describes APRETUDE, which is a drug marketed by Viiv Hlthcare and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the APRETUDE profile page.

The generic ingredient in APRETUDE is cabotegravir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cabotegravir profile page.

Summary for 215499

Tradename:	APRETUDE
Applicant:	Viiv Hlthcare
Ingredient:	cabotegravir
Patents:	4

Suppliers and Packaging for NDA: 215499

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499	NDA	ViiV Healthcare Company	49702-264	49702-264-23	1 KIT in 1 CARTON (49702-264-23) * 3 mL in 1 VIAL (49702-238-03)
APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499	NDA	ViiV Healthcare Company	49702-280	49702-280-63	1 KIT in 1 CARTON (49702-280-63) * 3 mL in 1 VIAL (49702-238-61)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	600MG/3ML (200MG/ML)
Approval Date:	Dec 20, 2021	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jan 21, 2026
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:	⤷ Start Trial	Patent Expiration:	Apr 28, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:	⤷ Start Trial	Patent Expiration:	Sep 15, 2031	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 215499

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	APRETUDE	cabotegravir	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	215499-001	Dec 20, 2021	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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