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Details for New Drug Application (NDA): 202992
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NDA 202992 describes AUBAGIO, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AUBAGIO profile page.
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.
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 202992
| Tradename: | AUBAGIO |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | teriflunomide |
| Patents: | 3 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202992
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Suppliers and Packaging for NDA: 202992
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AUBAGIO | teriflunomide | TABLET;ORAL | 202992 | NDA | Genzyme Corporation | 58468-0210 | 58468-0210-1 | 1 BLISTER PACK in 1 CARTON (58468-0210-1) > 5 TABLET, FILM COATED in 1 BLISTER PACK |
| AUBAGIO | teriflunomide | TABLET;ORAL | 202992 | NDA | Genzyme Corporation | 58468-0210 | 58468-0210-2 | 2 BLISTER PACK in 1 CARTON (58468-0210-2) > 14 TABLET, FILM COATED in 1 BLISTER PACK |
Paragraph IV (Patent) Challenges for 202992
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AUBAGIO | TABLET;ORAL | teriflunomide | 202992 | 2016-09-12 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 7MG | ||||
| Approval Date: | Sep 12, 2012 | TE: | AB | RLD: | Yes | ||||
| Patent: | Start Trial | Patent Expiration: | Sep 12, 2026 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 14, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | Patent Expiration: | Feb 4, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE | ||||||||
Expired US Patents for NDA 202992
| 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 |
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