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Last Updated: January 28, 2020

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TERIFLUNOMIDE Drug Profile

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When do Teriflunomide patents expire, and what generic alternatives are available?

Teriflunomide is a drug marketed by Accord Hlthcare, Alembic Pharms Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma Ltd, Glenmark Pharms, Msn Labs Pvt Ltd, Sandoz Inc, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

US ANDA Litigation and Generic Entry Outlook for Teriflunomide

A generic version of TERIFLUNOMIDE was approved as teriflunomide by GLENMARK PHARMS on January 28th, 2020.

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Drug patent expirations by year for TERIFLUNOMIDE
Recent Clinical Trials for TERIFLUNOMIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Jan LyckePhase 4
BiocadPhase 2
Providence Health & ServicesEarly Phase 1

See all TERIFLUNOMIDE clinical trials

Recent Litigation for TERIFLUNOMIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sanofi-Aventis U.S. LLC v. Hetero USA Inc.2017-01-11
Sanofi-Aventis U.S. LLC v. Zydus Pharmaceuticals (USA) Inc.2017-01-11
Sanofi-Aventis U.S. LLC v. Mylan Pharmaceuticals Inc.2017-01-10

See all TERIFLUNOMIDE litigation

Pharmacology for TERIFLUNOMIDE
Synonyms for TERIFLUNOMIDE
(2E)-2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
(2Z)-2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
(2z)-2-Cyano-3-Hydroxy-N-[4-(Trifluoromethyl)phenyl]but-2-Enamide
(2Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide (Teriflunomide)
(2Z)-3-oxidanylidene-2-[oxidanyl-[[4-(trifluoromethyl)phenyl]amino]methylidene]butanenitrile
(Z)-2-Cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide
(Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-butenamide
(Z)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide
(Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide
(Z)-2-Cyano-alpha'alpha'alpha-trifluoro-3-hydroxy-p-crotonotoluidide
108605-62-5
1185240-22-5
163451-81-8
1C058IKG3B
2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
2-Butenamide, 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-
2-Butenamide, 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-, (Z)-
2-Butenamide, 2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-
2-Butenamide, 2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-, (2Z)-
2-Cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-butenamide
2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide
2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2-butenamide
2-Cyano-3-OH-N-(4-trifluoromethylphenyl)croton amide
2-hydroxyethylidene-cyanoacetic acid-4-trifluoromethyl anilide
210165-52-9
A 1726
A 77-1726
A 771726
A-771726
A77 1726
A77-1726
A771726
A801897
AB01565775_02
AC-26446
AC1L1GYH
AC1L9H6I
AC1NUIOH
Active metabolite of leflunomide
AJ-63994
AK116138
AK144826
AKOS015994773
API0000341
Aubagio
Aubagio (TN)
BDBM50018011
C-16971
CC-10329
CHEBI:68540
CS-1031
D10172
DB08880
EN300-189832
Flucyamide
GTPL6844
HMR 1726
HMR-1726
HMR1726
HY-15405
J-010046
KB-80843
LE-0275
Leflunomide Impurity B
Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard
Leflunomide-d4 Metabolite (Teriflunomide-d4)
LS-46899
Malononitrilamide
MolPort-005-943-824
MolPort-035-386-190
N-(4-Trifluoromethylphenyl)-2-cyano-2-hydroxycrotonamide
N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide
N-(4-Trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide, 2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-beuteamide, LEF-M
N-[4-(Trifluoromethyl)phenyl]-2-cyano-3-hydroxycrotonamide
RS 61980
RS-61980
RT-011141
s4169
SB16822
SC-90977
SCHEMBL22661
ST24036515
SU 20
SU-0020
SW219377-1
Teriflunamide
teriflunomida
Teriflunomide (USAN)
Teriflunomide [INN]
Teriflunomide [USAN:INN]
Teriflunomide, A77 1726
Teriflunomide(A-771726)
Teriflunomide(Random Configuration)
teriflunomidum
UNII-1C058IKG3B
UTNUDOFZCWSZMS-YFHOEESVSA-N
ZINC13512456
Paragraph IV (Patent) Challenges for TERIFLUNOMIDE
Tradename Dosage Ingredient NDA Submissiondate
AUBAGIO TABLET;ORAL teriflunomide 202992 2016-09-12

US Patents and Regulatory Information for TERIFLUNOMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare TERIFLUNOMIDE teriflunomide TABLET;ORAL 209690-001 Jan 7, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa TERIFLUNOMIDE teriflunomide TABLET;ORAL 209700-002 Sep 4, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex TERIFLUNOMIDE teriflunomide TABLET;ORAL 209601-001 Nov 2, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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