You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 209668


✉ Email this page to a colleague

« Back to Dashboard


NDA 209668 describes TERIFLUNOMIDE, which is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Concord Biotech Ltd, Glenmark Speclt, Hetero Labs Ltd V, MSN, Natco, Sandoz, Sola Pharms, Somerset Theraps Llc, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen NDAs. It is available from eighteen suppliers. Additional details are available on the TERIFLUNOMIDE profile page.

The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
Summary for 209668
Tradename:TERIFLUNOMIDE
Applicant:Zydus Pharms
Ingredient:teriflunomide
Patents:0
Pharmacology for NDA: 209668
Mechanism of ActionDihydroorotate Dehydrogenase Inhibitors
Suppliers and Packaging for NDA: 209668
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209668 ANDA Zydus Pharmaceuticals USA Inc. 70710-1114 70710-1114-3 30 TABLET, FILM COATED in 1 BOTTLE (70710-1114-3)
TERIFLUNOMIDE teriflunomide TABLET;ORAL 209668 ANDA Zydus Pharmaceuticals USA Inc. 70710-1114 70710-1114-8 2 CARTON in 1 CARTON (70710-1114-8) / 1 BLISTER PACK in 1 CARTON (70710-1114-7) / 14 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7MG
Approval Date:Nov 30, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength14MG
Approval Date:Nov 30, 2018TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
© Copyright 2002-2025 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2025 - 2026
 NCE-1 Patent Challenge Dates 2025 - 2026
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links