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AUBAGIO Drug Profile
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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-seven patent family members in forty-five 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.
US ANDA Litigation and Generic Entry Outlook for Aubagio
A generic version of AUBAGIO was approved as teriflunomide by GLENMARK PHARMS on January 27th, 2020.
Summary for AUBAGIO
| International Patents: | 77 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 76 |
| Clinical Trials: | 9 |
| Patent Applications: | 1,001 |
| 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 |
| Centre hospitalier de l'Université de Montréal (CHUM) | Phase 4 |
| Genzyme, a Sanofi Company | Phase 4 |
Recent Litigation for AUBAGIO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Sanofi-Aventis U.S. LLC v. Zydus Pharmaceuticals (USA) Inc. | 2017-01-11 |
| Sanofi-Aventis U.S. LLC v. Hetero 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 |
Paragraph IV (Patent) Challenges for AUBAGIO
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AUBAGIO | TABLET;ORAL | teriflunomide | 202992 | 2016-09-12 |
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 | |||
| >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 | 202992-001 | Sep 12, 2012 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AUBAGIO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | 112012006184 | Start Trial |
| Japan | 2013505213 | 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 | 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 | 1490010-4 | Sweden | Start Trial | PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826 |
| 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 |
