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AUBAGIO Drug Profile
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When do Aubagio patents expire, and when can generic versions of Aubagio launch?
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.
The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for AUBAGIO
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 67 |
| Clinical Trials: | 9 |
| Patent Applications: | 786 |
| 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 |
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 |
| A77-1726 (monosodium salt) |
| 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 |
| D05LAR |
| D07QFP |
| D08TRA |
| D09PUR |
| D10172 |
| DB08880 |
| EN300-189832 |
| Flucyamide |
| GTPL6844 |
| HMR 1726 |
| HMR-1726 |
| HMR1726 |
| HY-15405 |
| J-010046 |
| KB-80843 |
| LE-0275 |
| Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard |
| Leflunomide-d4 Metabolite (Teriflunomide-d4) |
| LS-46899 |
| Malononitrilamide |
| MFCD00910058 |
| 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 |
| SC-90977 |
| SCHEMBL22661 |
| Simvistatin |
| ST24036515 |
| SU 20 |
| SU-0020 |
| Teriflunamide |
| teriflunomida |
| Teriflunomide |
| Teriflunomide (USAN) |
| Teriflunomide [INN] |
| Teriflunomide [USAN:INN] |
| Teriflunomide, A77 1726 |
| Teriflunomide(A-771726) |
| 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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | ➤ Sign Up | ||
| 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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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 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | ➤ Sign Up | ➤ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ➤ Sign Up | ➤ Sign Up |
| 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 | ➤ Sign Up |
Non-Orange Book US Patents for AUBAGIO
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,569,898 | United States Patent: 6569898 ( 1 | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for AUBAGIO
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Costa Rica | 20120116 | ➤ Sign Up |
| European Patent Office | 1935416 | ➤ Sign Up |
| Cyprus | 1119364 | ➤ Sign Up |
| Peru | 05622003 | ➤ Sign Up |
| Austria | 396719 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 6 | Finland | ➤ Sign Up | |
| 00644 | Netherlands | ➤ Sign Up | PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| 90010-4 | Sweden | ➤ Sign Up | PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826 |
| 1381356/01 | Switzerland | ➤ Sign Up | FUSION; FORMER OWNER: AVENTIS PHARMACEUTICALS INC., US |
| 2014004,C1381356 | Lithuania | ➤ Sign Up | PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
