FEBUXOSTAT Drug Patent Profile
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When do Febuxostat patents expire, and what generic alternatives are available?
Febuxostat is a drug marketed by Alembic, Alkem Labs Ltd, Aurobindo Pharma Ltd, Dr Reddys, Hikma, Indoco, Lupin Ltd, Macleods Pharms Ltd, MSN, Mylan, Prinston Inc, Sun Pharm, Sunshine, Torrent, and Zydus Lifesciences. and is included in fifteen NDAs.
The generic ingredient in FEBUXOSTAT is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the febuxostat profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Febuxostat
A generic version of FEBUXOSTAT was approved as febuxostat by ALEMBIC on July 1st, 2019.
Summary for FEBUXOSTAT
Recent Clinical Trials for FEBUXOSTAT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| JW Pharmaceutical | Phase 3 |
| Chinese University of Hong Kong | Phase 2 |
| Tanta University | Phase 2 |
Pharmacology for FEBUXOSTAT
| Drug Class | Xanthine Oxidase Inhibitor |
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for FEBUXOSTAT
Anatomical Therapeutic Chemical (ATC) Classes for FEBUXOSTAT
Paragraph IV (Patent) Challenges for FEBUXOSTAT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ULORIC | Tablets | febuxostat | 40 mg and 80 mg | 021856 | 10 | 2013-02-13 |
US Patents and Regulatory Information for FEBUXOSTAT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Torrent | FEBUXOSTAT | febuxostat | TABLET;ORAL | 211837-002 | Dec 19, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Zydus Lifesciences | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205443-001 | Jan 9, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alembic | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205421-001 | Jul 1, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Msn | FEBUXOSTAT | febuxostat | TABLET;ORAL | 210461-002 | Dec 30, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Sun Pharm | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205467-002 | Jul 1, 2019 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205374-001 | Oct 22, 2020 | 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 FEBUXOSTAT
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Krka, d.d., Novo mesto | Febuxostat Krka | febuxostat | EMEA/H/C/004773 Febuxostat Krka is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Krka is indicated in adults. |
Authorised | yes | no | no | 2019-03-28 | |
| Mylan Pharmaceuticals Limited | Febuxostat Mylan | febuxostat | EMEA/H/C/004374 Febuxostat Mylan is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Febuxostat Mylan is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Febuxostat Mylan is indicated in adults. |
Authorised | yes | no | no | 2017-06-15 | |
| Menarini International Operations Luxembourg S.A. (MIOL) | Adenuric | febuxostat | EMEA/H/C/000777 80 mg strength:Treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Adenuric is indicated in adults.120 mg strength:Adenuric is indicated for the treatment of chronic hyperuricaemia in conditions where urate deposition has already occurred (including a history, or presence of, tophus and/or gouty arthritis).Adenuric is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).Adenuric is indicated in adults. |
Authorised | no | no | no | 2008-04-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
