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Last Updated: March 19, 2024

ARAVA Drug Patent Profile


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Which patents cover Arava, and when can generic versions of Arava launch?

Arava is a drug marketed by Sanofi Aventis Us and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Arava

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

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US Patents and Regulatory Information for ARAVA

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 020905-001 Sep 10, 1998 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-002 Sep 10, 1998 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us ARAVA leflunomide TABLET;ORAL 020905-003 Sep 10, 1998 RX Yes Yes ⤷  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 ARAVA

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for ARAVA

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ARAVA

See the table below for patents covering ARAVA around the world.

Country Patent Number Title Estimated Expiration
Cyprus 2033 New derivative of cyano crotonamide as medicament with immunomodulating properties ⤷  Try a Trial
European Patent Office 0217206 Médicament contre les maladies chroniques de rejet de greffe ainsi que contre les maladies de l'auto-immunité, notamment le lupus érythémateux systémique. (Medicament against chronic graft-versus-host diseases, as well as against autoimmune diseases, particularly systemic lupus erythematodes.) ⤷  Try a Trial
Israel 80149 PHARMACEUTICAL COMPOSITIONS CONTAINING TOLUIDIDE DERIVATIVES AGAINST GRAFT-VERSUS-HOST DISEASES AND AUTOIMMUNE DISEASES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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. 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.