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Last Updated: December 14, 2019

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Teriflunomide - Generic Drug Details

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What are the generic drug sources for teriflunomide and what is the scope of patent protection?

Teriflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Alembic Pharms Ltd, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms, Msn Labs Pvt Ltd, Sandoz Inc, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Teriflunomide has seventy-five patent family members in forty-four countries.

There are nineteen drug master file entries for teriflunomide. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for teriflunomide

International Patents:	75
US Patents:	3
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	19
Suppliers / Packagers:	3
Bulk Api Vendors:	77
Clinical Trials:	34
Patent Applications:	1,731
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teriflunomide
DailyMed Link:	teriflunomide at DailyMed

Recent Clinical Trials for teriflunomide

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

Sponsor	Phase
Jan Lycke	Phase 4
Biocad	Phase 2
Providence Health & Services	Early Phase 1

See all teriflunomide clinical trials

Recent Litigation for teriflunomide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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

Generic filers with tentative approvals for TERIFLUNOMIDE

Applicant	Application No.	Strength	Dosage Form
Start Trial	Start Trial	14MG	TABLET;ORAL
Start Trial	Start Trial	7MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for teriflunomide

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms Co	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209613-002	Sep 28, 2018		DISCN	No	No	Start Trial	Start Trial				Start Trial
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-001	Nov 15, 2018	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-002	Nov 15, 2018	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Apotex Inc	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

Expired US Patents for teriflunomide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	Start Trial	Start Trial
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	Start Trial	Start Trial
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	Start Trial	Start Trial
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for teriflunomide

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Country	Patent Number	Estimated Expiration
European Patent Office	2762135	Start Trial
Peru	14782012	Start Trial
Panama	8542901	Start Trial
Peru	20030562	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for teriflunomide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	122014000009	Germany	Start Trial	PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	2014C/008	Belgium	Start Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1381356	PA2014004	Lithuania	Start Trial	PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	92366	Luxembourg	Start Trial	PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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