Question 1

Is there a generic for Cabotegravir?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Cabotegravir. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Cabotegravir?

Accepted Answer

APRETUDE (NDA 215499, VIIV HLTHCARE) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Cabotegravir?

Accepted Answer

The Orange Book lists 4 patents against Cabotegravir products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Cabotegravir have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Cabotegravir. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Cabotegravir are approved?

Accepted Answer

Cabotegravir is approved in the following dosage form: suspension, extended release.

Patent	Expires	In	Type
10927129	Apr 28, 2026	2 mo ago	SubstanceProduct
8410103	Feb 04, 2031	in 4 yr 8 mo	SubstanceProduct
12138264	Sep 15, 2031	in 5 yr 4 mo	Product
11224597	Sep 15, 2031	in 5 yr 4 mo	Product

Cabotegravir

Brand (NDA) products · suspension, extended release

Marketing exclusivity (1)

Listed patents (4)

Cabotegravir — frequently asked questions

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