Orange Book product · Brand (NDA)

APRETUDE

CABOTEGRAVIR

Brand (NDA)NDA 215499RX VIIV HLTHCARE

Dec 20, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 20, 2021
4 yr 7 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 21, 2026
5 mo ago
Patent 10927129 expires
Listed drug substance patent expiration.
Apr 28, 2026
2 mo ago
Today
Patent 8410103 expires
Listed drug substance patent expiration.
Feb 04, 2031
in 4 yr 8 mo
Patent 11224597 expires
Listed drug product patent expiration.
Sep 15, 2031
in 5 yr 4 mo
Patent 12138264 expires
Listed drug product patent expiration.
Sep 15, 2031
in 5 yr 4 mo

Active ingredient

CABOTEGRAVIR

Strength

600MG/3ML (200MG/ML)

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 215499

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10927129	Apr 28, 2026	2 mo ago	SubstanceProduct
8410103	Feb 04, 2031	in 4 yr 8 mo	SubstanceProduct
11224597	Sep 15, 2031	in 5 yr 4 mo	Product
12138264	Sep 15, 2031	in 5 yr 4 mo	Product