Is there a generic for Etravirine?

Yes. The FDA Orange Book lists 3 approved generic (ANDA) applications for Etravirine, referencing the brand INTELENCE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Etravirine?

INTELENCE (NDA 022187, JANSSEN R AND D) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Etravirine are approved?

Etravirine is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Etravirine

Etravirine is approved as 1 brand and 3 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:INTELENCE · NDA 022187

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
INTELENCERLD×3	JANSSEN R AND D	NDA 022187	—	Mar 26, 2012

Generic (ANDA) products (3)

Product	Applicant	Application	TE	Approved
ETRAVIRINE×2	BIONPHARMA	ANDA 219152	AB	Oct 02, 2025
ETRAVIRINE×2	CARNEGIE	ANDA 215402	AB	Apr 13, 2022
ETRAVIRINE×3	AMNEAL	ANDA 214196	—	Jun 14, 2021

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Etravirine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo