FDA Orange Book

Generic for Edurant

Edurant contains rilpivirine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

Yes. The generic name for Edurant is rilpivirine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

Run it in Rivvi

Map Edurant and your other top fills to their generics

Every strength in RxNorm, with brands that have no generic flagged.

Build the map

Free to start. Opens Rivvi, the AI workspace for healthcare teams.

Edurant products in the Orange Book

Edurant products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 25MG BASE	Marketed (Rx)	AB	2	AB

NDA 202022, held by JANSSEN PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic rilpivirine

Approved generic versions of Edurant
Company	ANDA	TE code	Approved	Strengths
SOMERSET THERAPEUTICS LLC	218798	AB (A-rated, therapeutically equivalent)	January 29, 2026	EQ 25MG BASE
LAURUS LABS LTD	219788	AB (A-rated, therapeutically equivalent)	July 10, 2026	EQ 25MG BASE

Edurant exclusivity

Exclusivity listed for Edurant
Code	Meaning	Expires	NDA
NPP	New patient population	March 15, 2027	202022
PED	Pediatric exclusivity	September 15, 2027	202022

Edurant NDC codes

59676-278

Questions

Is there a generic for Edurant?

Yes. The generic name for Edurant is rilpivirine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Edurant?

The active ingredient in Edurant is rilpivirine, per the FDA Orange Book.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.