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Last Updated: March 19, 2024

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, Aet Pharma, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma, Barr, Heritage Pharms, Lupin Ltd, Sandoz, Teva Pharms, Wanbang Biopharms, 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. Seventeen suppliers are listed for this compound.

Drug Prices for leflunomide

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Recent Clinical Trials for leflunomide

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SponsorPhase
University Hospital, Basel, SwitzerlandN/A
Al-Azhar UniversityPhase 2/Phase 3
Ain Shams UniversityPhase 2/Phase 3

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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
Apotex Inc LEFLUNOMIDE leflunomide TABLET;ORAL 077090-001 Sep 13, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic Pharms Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 091369-002 Nov 21, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz LEFLUNOMIDE leflunomide TABLET;ORAL 077085-002 Sep 13, 2005 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic Pharms Ltd LEFLUNOMIDE leflunomide TABLET;ORAL 091369-001 Nov 21, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Apotex Inc LEFLUNOMIDE leflunomide TABLET;ORAL 077090-002 Sep 13, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wanbang Biopharms LEFLUNOMIDE leflunomide TABLET;ORAL 077087-002 Sep 13, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 020905-003 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-001 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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
Teva Pharma B.V. Leflunomide Teva leflunomide EMEA/H/C/002356
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.
Withdrawn yes no no 2011-03-10
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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