Is there a generic for Teriflunomide?

Yes. The FDA Orange Book lists 19 approved generic (ANDA) applications for Teriflunomide, referencing the brand AUBAGIO. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Teriflunomide?

AUBAGIO (NDA 202992, SANOFI AVENTIS US) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Teriflunomide?

The Orange Book lists 6 patents against Teriflunomide 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.

What dosage forms of Teriflunomide are approved?

Teriflunomide is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Teriflunomide

Teriflunomide is approved as 1 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AUBAGIO · NDA 202992

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · tablet

Product	Applicant	Application	TE	Approved
AUBAGIORLD×2	SANOFI AVENTIS US	NDA 202992	AB	Sep 12, 2012

Generic (ANDA) products (19)

Product	Applicant	Application	TE	Approved
TERIFLUNOMIDE×2	CONCORD BIOTECH LTD	ANDA 218663	AB	Apr 07, 2025
TERIFLUNOMIDE×2	TORRENT	ANDA 209697	—	Apr 04, 2024
TERIFLUNOMIDE×2	SOLA PHARMS	ANDA 209677	AB	Sep 28, 2023
TERIFLUNOMIDE×2	NATCO	ANDA 209555	AB	May 15, 2023
TERIFLUNOMIDE×2	BIOCON PHARMA	ANDA 209639	AB	Mar 13, 2023
TERIFLUNOMIDE×2	HETERO LABS LTD V	ANDA 209598	AB	Mar 13, 2023
TERIFLUNOMIDE×2	BRECKENRIDGE	ANDA 209583	—	Sep 24, 2021
TERIFLUNOMIDE×2	SOMERSET THERAPS LLC	ANDA 209702	—	Feb 28, 2020
TERIFLUNOMIDE×2	MSN	ANDA 209623	AB	Apr 24, 2019
TERIFLUNOMIDE×2	ALEMBIC	ANDA 209572	AB	Apr 19, 2019
TERIFLUNOMIDE×2	ACCORD HLTHCARE	ANDA 209690	AB	Jan 07, 2019
TERIFLUNOMIDE×2	SANDOZ	ANDA 209710	AB	Jan 03, 2019
TERIFLUNOMIDE×2	ZYDUS PHARMS	ANDA 209668	AB	Nov 30, 2018
TERIFLUNOMIDE×2	GLENMARK SPECLT	ANDA 209663	AB	Nov 15, 2018
TERIFLUNOMIDE×2	APOTEX	ANDA 209601	—	Nov 02, 2018
TERIFLUNOMIDE×2	AUROBINDO PHARMA	ANDA 209638	AB	Oct 26, 2018
TERIFLUNOMIDE×2	AMNEAL PHARMS CO	ANDA 209613	—	Sep 28, 2018
TERIFLUNOMIDE×2	TEVA PHARMS USA	ANDA 209700	AB	Sep 04, 2018
TERIFLUNOMIDE×2	WATSON LABS TEVA	ANDA 209549	—	Jul 27, 2018

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
6794410	Sep 12, 2026	in 3 mo	U-1285
6794410*PED	Mar 12, 2027	in 9 mo
8802735	Sep 14, 2030	in 4 yr 4 mo	Product
8802735*PED	Mar 14, 2031	in 4 yr 10 mo
9186346	Feb 04, 2034	in 7 yr 9 mo	U-1786
9186346*PED	Aug 04, 2034	in 8 yr 3 mo

Teriflunomide — frequently asked questions

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

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