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, 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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Questions you can ask:
- What is the 5 year forecast for LEFLUNOMIDE?
- What are the global sales for LEFLUNOMIDE?
- What is Average Wholesale Price for LEFLUNOMIDE?
Summary for LEFLUNOMIDE
| US Patents: | 0 |
| Applicants: | 12 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 16 |
| Raw Ingredient (Bulk) Api Vendors: | 142 |
| Clinical Trials: | 100 |
| Patent Applications: | 4,420 |
| Drug Prices: | Drug price information for LEFLUNOMIDE |
| Drug Sales Revenues: | Drug sales revenues for LEFLUNOMIDE |
| What excipients (inactive ingredients) are in LEFLUNOMIDE? | LEFLUNOMIDE excipients list |
| DailyMed Link: | LEFLUNOMIDE at DailyMed |
See drug prices for LEFLUNOMIDE
Recent Clinical Trials for LEFLUNOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Basel, Switzerland | N/A |
| Ain Shams University | Phase 2/Phase 3 |
| Misr International University | Phase 2/Phase 3 |
Pharmacology for LEFLUNOMIDE
| Drug Class | Antirheumatic Agent |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
