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Febuxostat - Generic Drug Details
What are the generic sources for febuxostat and what is the scope of freedom to operate?
Febuxostat
is the generic ingredient in two branded drugs marketed by Alembic Pharms Ltd, Mylan, Sun Pharm, and Takeda Pharms Usa, and is included in four NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Febuxostat has one hundred and five patent family members in thirty-five countries.
There are twenty-six drug master file entries for febuxostat. Seven suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for febuxostat
| International Patents: | 105 |
| US Patents: | 5 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 7 |
| Bulk Api Vendors: | 115 |
| Clinical Trials: | 65 |
| Patent Applications: | 366 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for febuxostat |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for febuxostat |
| DailyMed Link: | febuxostat at DailyMed |
Recent Clinical Trials for febuxostat
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Instituto Nacional de Cardiologia Ignacio Chavez | Phase 3 |
| Instituto Nacional de Rehabilitacion | Phase 3 |
| Altasciences Company Inc. | Phase 1 |
Recent Litigation for febuxostat
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teijin Limited v. Alkem Laboratories Limited | 2019-04-26 |
| Teijin Limited v. Torrent Pharmaceuticals Ltd. | 2018-07-02 |
| Teijin Limited v. MSN Laboratories Private Ltd. | 2018-06-14 |
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
Synonyms for febuxostat
| 060F537 |
| 101V0R1N2E |
| 111GE013 |
| 144060-53-7 |
| 2-(3-Cyano-4-(2-methylpropoxy)phenyl)-4-methylthiazole-5-carboxylic acid |
| 2-(3-CYANO-4-ISOBUTOXY-PHENYL)-4-METHYL-5-THIAZOLE-CARBOXYLIC ACID |
| 2-(3-cyano-4-isobutoxy-phenyl)-4-methyl-thiazole-5-carboxylic acid |
| 2-(3-cyano-4-isobutoxyphenyl)-4-methyl- 1,3-thiazole-5-carboxylic acid |
| 2-(3-Cyano-4-isobutoxyphenyl)-4-methyl-5-thiazolecarboxylic acid |
| 2-(3-cyano-4-isobutoxyphenyl)-4-methylthiazole-5-carboxylic acid |
| 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-1,3-thiazole-5-carboxylic acid |
| 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl-5-thiazolecarboxylic acid |
| 2-[3-Cyano-4-isobutoxyphenyl]-4-methylthiazole-5-carboxylic acid |
| 5-Thiazolecarboxylic acid, 2-(3-cyano-4-(2-methylpropoxy)phenyl)-4-methyl- |
| 5-Thiazolecarboxylic acid, 2-[3-cyano-4-(2-methylpropoxy)phenyl]-4-methyl- |
| AB0005158 |
| AB01274796_02 |
| AB01274796_03 |
| AB01274796-01 |
| AB2000143 |
| ABP000399 |
| AC-425 |
| AC1L33UC |
| ACT06289 |
| Adenuric |
| Adenuric, Uloric , Febutaz |
| AK-83533 |
| AKOS015841695 |
| AM20090760 |
| AN-608 |
| ANW-46040 |
| API0004334 |
| BB_SC-12106 |
| BC220527 |
| BCP02342 |
| BCP9000679 |
| BCPP000233 |
| BDBM50320491 |
| BQSJTQLCZDPROO-UHFFFAOYSA-N |
| BRD-K48367671-001-01-8 |
| BS-1018 |
| C-23827 |
| C16H16N2O3S |
| CAS-144060-53-7 |
| CC-28363 |
| CCG-213303 |
| CHEBI:31596 |
| CHEMBL1164729 |
| CS-0403 |
| CTK8B4748 |
| D01206 |
| DB04854 |
| DSSTox_CID_28576 |
| DSSTox_GSID_48650 |
| DSSTox_RID_82848 |
| DTXSID8048650 |
| EN300-122360 |
| F0847 |
| FC0017 |
| FD7322 |
| Febric |
| Feburic |
| Feburic (TN) |
| Febuxostat (JAN/USAN/INN) |
| Febuxostat (Uloric) |
| Febuxostat [USAN:INN:BAN] |
| Febuxostat [USAN] |
| Febuxostat, >=98% (HPLC) |
| Febuxostat,Uloric, TMX-67 |
| Febuxostat; |
| Febuxostat(TEI 6720) |
| Febuxostat(Uloric) / |
| Febuxostatum |
| FT-0081351 |
| FT-0601639 |
| GTPL6817 |
| HMS3264C20 |
| HMS3655C03 |
| HY-14268 |
| J10392 |
| KS-00000G8Y |
| LS-173202 |
| MCULE-6974079178 |
| MLS004774136 |
| MLS006011568 |
| MolPort-005-940-740 |
| MX-67 |
| NCGC00182059-02 |
| NCGC00182059-03 |
| NSC-758874 |
| NSC758874 |
| PB33929 |
| Pharmakon1600-01504286 |
| Q-100164 |
| Q-4339 |
| RP17652 |
| RTC-070914 |
| S033 |
| S1547 |
| SC-20178 |
| SCHEMBL249339 |
| SMR002529566 |
| SR-01000940023 |
| SR-01000940023-2 |
| ST24027508 |
| SW219283-1 |
| TC-070914 |
| TEI |
| Tei 6720 |
| Tei-6720 |
| TMX 67 |
| TMX-67 |
| TMX-67;Adenuric;Uloric |
| Tox21_113004 |
| Tox21_113004_1 |
| Uloric |
| Uloric (TN) |
| UNII-101V0R1N2E |
| Z1550648761 |
| ZINC5423 |
| Zurig |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | AB | RX | 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 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 |
|---|---|---|
| Brazil | 112013005792 | Start Trial |
| Hungary | 9202265 | Start Trial |
| China | 1642546 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for febuxostat
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1020454 | CR 2010 00015 | Denmark | Start Trial | PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421 |
| 1020454 | SPC/GB10/019 | United Kingdom | Start Trial | SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB10/019 GRANTED TO TEIJIN LIMITED IN RESPECT OF THE PRODUCT FEBUXOSTAT, THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6408 DATED 14/03/2012 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 22/04/2023. |
| 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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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. thinkBiotech performs no independent verifification 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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DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.