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Last Updated: November 2, 2024

LEFLUNOMIDE Drug Patent Profile


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When do Leflunomide patents expire, and what generic alternatives are available?

Leflunomide is a drug marketed by Abhai Llc, Aet Pharma, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Barr, Heritage Pharms, Lupin Ltd, Sandoz, Teva Pharms, Wanbang Biopharms, and Zydus Lifesciences. and is included in twelve NDAs.

The generic ingredient in LEFLUNOMIDE is leflunomide. There are seven drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the leflunomide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Leflunomide

A generic version of LEFLUNOMIDE was approved as leflunomide by APOTEX INC on September 13th, 2005.

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Drug patent expirations by year for LEFLUNOMIDE
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Recent Clinical Trials for LEFLUNOMIDE

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SponsorPhase
University Hospital, Basel, SwitzerlandN/A
Ain Shams UniversityPhase 2/Phase 3
Misr International UniversityPhase 2/Phase 3

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
Abhai Llc LEFLUNOMIDE leflunomide TABLET;ORAL 212453-001 Jun 3, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sandoz LEFLUNOMIDE leflunomide TABLET;ORAL 077085-002 Sep 13, 2005 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences LEFLUNOMIDE leflunomide TABLET;ORAL 212308-002 Apr 24, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex Inc LEFLUNOMIDE leflunomide TABLET;ORAL 077090-001 Sep 13, 2005 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aet Pharma LEFLUNOMIDE leflunomide TABLET;ORAL 213497-002 May 10, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for LEFLUNOMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Zentiva k.s. Leflunomide Zentiva (previously Leflunomide Winthrop) leflunomide EMEA/H/C/001129
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Authorised no no no 2010-01-08
Ratiopharm GmbH Leflunomide ratiopharm leflunomide EMEA/H/C/002035
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Authorised yes no no 2010-11-28
medac Gesellschaft für klinische Spezialpräparate mbH Leflunomide medac leflunomide EMEA/H/C/001227
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD).Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions, therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Authorised yes no no 2010-07-27
Sanofi-aventis Deutschland GmbH Arava leflunomide EMEA/H/C/000235
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Authorised no no no 1999-09-02
Teva B.V. Repso leflunomide EMEA/H/C/001222
Leflunomide is indicated for the treatment of adult patients with:active rheumatoid arthritis as a ‘disease-modifying antirheumatic drug’ (DMARD);active psoriatic arthritis.Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects.Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.
Withdrawn yes no no 2011-03-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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