FDA Orange Book

Generic for Aubagio

Aubagio contains teriflunomide. 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 Aubagio is teriflunomide. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Aubagio products in the Orange Book

Aubagio products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	14MG	Marketed (Rx)	AB	13	AB
tablet, oral	7MG	Marketed (Rx)	AB	13	AB

NDA 202992, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic teriflunomide

Approved generic versions of Aubagio
Company	ANDA	TE code	Approved	Strengths
TEVA PHARMACEUTICALS USA INC	209700	AB (A-rated, therapeutically equivalent)	September 4, 2018	14MG, 7MG
AUROBINDO PHARMA LTD	209638	AB (A-rated, therapeutically equivalent)	October 26, 2018	14MG, 7MG
GLENMARK SPECIALTY SA	209663	AB (A-rated, therapeutically equivalent)	November 15, 2018	14MG, 7MG
ZYDUS PHARMACEUTICALS USA INC	209668	AB (A-rated, therapeutically equivalent)	November 30, 2018	14MG, 7MG
SANDOZ INC	209710	AB (A-rated, therapeutically equivalent)	January 3, 2019	14MG, 7MG
ACCORD HEALTHCARE INC	209690	AB (A-rated, therapeutically equivalent)	January 7, 2019	14MG, 7MG
ALEMBIC PHARMACEUTICALS LTD	209572	AB (A-rated, therapeutically equivalent)	April 19, 2019	14MG, 7MG
MSN LABORATORIES PRIVATE LTD	209623	AB (A-rated, therapeutically equivalent)	April 24, 2019	14MG, 7MG
SOLA PHARMACEUTICALS	209677	AB (A-rated, therapeutically equivalent)	June 17, 2020	14MG, 7MG
BIOCON PHARMA LTD	209639	AB (A-rated, therapeutically equivalent)	March 13, 2023	14MG, 7MG
HETERO LABS LTD UNIT V	209598	AB (A-rated, therapeutically equivalent)	March 13, 2023	14MG, 7MG
NATCO PHARMA LTD	209555	AB (A-rated, therapeutically equivalent)	May 15, 2023	14MG, 7MG
NEOCUBES PHARMA LLP	218663	AB (A-rated, therapeutically equivalent)	April 7, 2025	14MG, 7MG

Aubagio patents

Patents listed for Aubagio
Patent	Expires	Covers	Use code	NDA
6794410	September 12, 2026	Method of use	U-1285	202992
6794410*PED	March 12, 2027	Method of use	None	202992
8802735	September 14, 2030	Drug product	None	202992
8802735*PED	March 14, 2031	Method of use	None	202992
9186346	February 4, 2034	Method of use	U-1786	202992
9186346*PED	August 4, 2034	Method of use	None	202992

Aubagio NDC codes

Questions

Is there a generic for Aubagio?

Yes. The generic name for Aubagio is teriflunomide. 13 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 Aubagio?

The active ingredient in Aubagio is teriflunomide, per the FDA Orange Book.

When does the Aubagio patent expire?

The last patent listed for Aubagio in the Orange Book expires August 4, 2034. A listed patent expiry date is not a generic launch date.

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.