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Last Updated: August 2, 2021

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Leflunomide - Generic Drug Details

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What are the generic drug sources for leflunomide and what is the scope of freedom to operate?

Leflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Abhai Llc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Axunio, Barr, Fosun Pharma, Heritage Pharms Inc, Lupin Ltd, Sandoz, Teva Pharms, and Zydus, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for leflunomide. Thirteen suppliers are listed for this compound.

Drug Prices for leflunomide

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Drug Sales Revenue Trends for leflunomide

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Recent Clinical Trials for leflunomide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Tata Memorial CentrePhase 2
Second Affiliated Hospital, School of Medicine, Zhejiang UniversityPhase 4
Second Affiliated Hospital of Nanchang UniversityN/A

See all leflunomide clinical trials

Pharmacology for leflunomide

US Patents and Regulatory Information for leflunomide

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 ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Axunio LEFLUNOMIDE leflunomide TABLET;ORAL 213497-001 May 10, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Barr LEFLUNOMIDE leflunomide TABLET;ORAL 077083-002 Sep 13, 2005 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Inc LEFLUNOMIDE leflunomide TABLET;ORAL 077090-001 Sep 13, 2005 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lupin Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 211863-002 Feb 4, 2020 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 leflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
McKesson
Johnson and Johnson
Moodys
McKinsey

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