ARAVA Drug Patent Profile
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When do Arava patents expire, and what generic alternatives are available?
Arava is a drug marketed by Sanofi Aventis Us and is included in one NDA.
The generic ingredient in ARAVA is leflunomide. There is one drug master file entry 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 on September 13th, 2005.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ARAVA?
- What are the global sales for ARAVA?
- What is Average Wholesale Price for ARAVA?
Summary for ARAVA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 112 |
| Patent Applications: | 4,999 |
| Drug Prices: | Drug price information for ARAVA |
| What excipients (inactive ingredients) are in ARAVA? | ARAVA excipients list |
| DailyMed Link: | ARAVA at DailyMed |
Pharmacology for ARAVA
| Drug Class | Antirheumatic Agent |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905-002 | Sep 10, 1998 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905-003 | Sep 10, 1998 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | 020905-002 | Sep 10, 1998 | 4,284,786 | ⤷ Start Trial |
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905-003 | Sep 10, 1998 | 4,351,841 | ⤷ Start Trial |
| Sanofi Aventis Us | ARAVA | leflunomide | TABLET;ORAL | 020905-001 | Sep 10, 1998 | 4,284,786 | ⤷ Start 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/001129Leflunomide 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/002035Leflunomide 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/001227Leflunomide 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 |
|---|---|---|---|
| Argentina | 222680 | PROCEDIMIENTO PARA LA PREPARACION DE (4-TRIFLUOR-METIL)-ANILIDA DE ACIDO 5-METILISOXAZOL-4-CARBOXILICO | ⤷ Start Trial |
| Argentina | 226894 | PROCEDIMIENTO PARA OBTENER(4-TRIFLUORMETIL ANILIDA DE ACIDO 5-METIL ISOXAZOL-4-CARBOXILICO | ⤷ Start Trial |
| Austria | 1067 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
DrugChatter Q&A for ARAVA
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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. 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.
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