TERIFLUNOMIDE Drug Patent Profile
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Which patents cover Teriflunomide, and when can generic versions of Teriflunomide launch?
Teriflunomide is a drug marketed by Accord Hlthcare, Alembic, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Pharms, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms. and is included in seventeen NDAs.
The generic ingredient in TERIFLUNOMIDE is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Teriflunomide
A generic version of TERIFLUNOMIDE was approved as teriflunomide by TEVA PHARMS USA on September 4th, 2018.
Summary for TERIFLUNOMIDE
Recent Clinical Trials for TERIFLUNOMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1/Phase 2 |
| Novartis Pharmaceuticals | Phase 4 |
| Oslo University Hospital | Phase 1/Phase 2 |
Pharmacology for TERIFLUNOMIDE
| Drug Class | Pyrimidine Synthesis Inhibitor |
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TERIFLUNOMIDE
Paragraph IV (Patent) Challenges for TERIFLUNOMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| AUBAGIO | Tablets | teriflunomide | 7 mg and 14 mg | 202992 | 21 | 2016-09-12 |
US Patents and Regulatory Information for TERIFLUNOMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs Teva | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209549-002 | Jul 27, 2018 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Sola Pharms | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209677-001 | Jun 17, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Zydus Pharms | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209668-001 | Nov 30, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209700-001 | Sep 4, 2018 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Accord Hlthcare | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209690-001 | Jan 7, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hetero Labs Ltd V | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209598-002 | Mar 13, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Natco | TERIFLUNOMIDE | teriflunomide | TABLET;ORAL | 209555-002 | May 15, 2023 | 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 |
EU/EMA Drug Approvals for TERIFLUNOMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Winthrop Industrie | Aubagio | teriflunomide | EMEA/H/C/002514 AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). |
Authorised | no | no | no | 2013-08-26 | |
| Accord Healthcare S.L.U. | Teriflunomide Accord | teriflunomide | EMEA/H/C/005960 Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). |
Authorised | yes | no | no | 2022-11-09 | |
| Mylan Pharmaceuticals Limited | Teriflunomide Mylan | teriflunomide | EMEA/H/C/005962 Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established). |
Authorised | yes | no | no | 2022-11-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
