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Febuxostat - Generic Drug Details
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What are the generic drug sources for febuxostat and what is the scope of patent protection?
Febuxostat
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Dr Reddys Labs Ltd, Hikma, Indoco, MSN, Mylan, Sun Pharm, Sunshine, and Takeda Pharms Usa, and is included in nine NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Febuxostat has twenty-eight patent family members in fifteen countries.
There are twenty-six drug master file entries for febuxostat. Seventeen suppliers are listed for this compound. There are five tentative approvals for this compound.
Summary for febuxostat
International Patents: | 28 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 26 |
Suppliers / Packagers: | 17 |
Bulk Api Vendors: | 123 |
Clinical Trials: | 72 |
Patent Applications: | 1,533 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for febuxostat |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for febuxostat |
What excipients (inactive ingredients) are in febuxostat? | febuxostat excipients list |
DailyMed Link: | febuxostat at DailyMed |
Recent Clinical Trials for febuxostat
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Taiwan University Hospital, Yun-Lin Branch | N/A |
National Taiwan University Hospital | N/A |
Ai Peng | N/A |
Generic filers with tentative approvals for FEBUXOSTAT
Applicant | Application No. | Strength | Dosage Form |
Start Trial | Start Trial | 80MG | TABLET;ORAL |
Start Trial | Start Trial | 40MG | TABLET;ORAL |
Start Trial | Start Trial | 80MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for febuxostat
Drug Class | Xanthine Oxidase Inhibitor |
Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for febuxostat
Paragraph IV (Patent) Challenges for FEBUXOSTAT
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ULORIC | TABLET;ORAL | febuxostat | 021856 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205385-001 | Jul 1, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Hikma | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205414-002 | Oct 15, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Hikma | FEBUXOSTAT | febuxostat | TABLET;ORAL | 205414-001 | Oct 15, 2019 | AB | RX | No | 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 febuxostat
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | Start Trial | Start Trial |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | Start Trial | Start Trial |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for febuxostat
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2012033941 | Start Trial |
Japan | 2013539747 | Start Trial |
European Patent Office | 2613780 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for febuxostat
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1020454 | 10C0022 | France | Start Trial | PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
1020454 | 19/2010 | Austria | Start Trial | PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
1020454 | PA 2010 005, C 1020454 | Lithuania | Start Trial | PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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