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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 |
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 |
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
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
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
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
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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