DrugPatentWatch Database Preview
AUBAGIO Drug Profile
When do Aubagio patents expire, and what generic alternatives are available?
Aubagio is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has seventy-five patent family members in forty-four countries.
The generic ingredient in AUBAGIO 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.
Summary for AUBAGIO
| International Patents: | 75 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 77 |
| Clinical Trials: | 9 |
| Patent Applications: | 974 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for AUBAGIO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AUBAGIO |
| DailyMed Link: | AUBAGIO at DailyMed |
Recent Clinical Trials for AUBAGIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Novartis Pharmaceuticals | Phase 3 |
| Genzyme, a Sanofi Company | Phase 4 |
| Montreal Neurological Institute and Hospital | Phase 4 |
Recent Litigation for AUBAGIO
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 |
Pharmacology for AUBAGIO
| Drug Class | Pyrimidine Synthesis Inhibitor |
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Synonyms for AUBAGIO
| (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 (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 |
| Teriflunomide (USAN) |
| Teriflunomide [INN] |
| Teriflunomide [USAN:INN] |
| Teriflunomide, A77 1726 |
| Teriflunomide(A-771726) |
| Teriflunomide(Random Configuration) |
| teriflunomidum |
| UNII-1C058IKG3B |
| UTNUDOFZCWSZMS-YFHOEESVSA-N |
| ZINC13512456 |
US Patents and Regulatory Information for AUBAGIO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | 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 AUBAGIO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 202992-002 | 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 |
Paragraph IV (Patent) Challenges for AUBAGIO
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 7 mg and 14 mg | ➤ Subscribe | Start Trial |
International Patents for AUBAGIO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 104666238 | Start Trial |
| Chile | 2015000047 | Start Trial |
| European Patent Office | 1935416 | Start Trial |
| Honduras | 2012000576 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1381356 | 486 | Finland | Start Trial | |
| 1381356 | 14C0010 | France | Start Trial | PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| 1381356 | C01381356/01 | Switzerland | Start Trial | FUSION; FORMER OWNER: AVENTIS PHARMACEUTICALS INC., US |
| 1381356 | C300644 | Netherlands | Start Trial | PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
