ULORIC Drug Patent Profile
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Which patents cover Uloric, and what generic alternatives are available?
Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-eight patent family members in fifteen countries.
The generic ingredient in ULORIC 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 Uloric
A generic version of ULORIC was approved as febuxostat by ALEMBIC on July 1st, 2019.
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Questions you can ask:
- What is the 5 year forecast for ULORIC?
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Summary for ULORIC
International Patents: | 28 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 139 |
Clinical Trials: | 27 |
Patent Applications: | 629 |
Drug Prices: | Drug price information for ULORIC |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ULORIC |
What excipients (inactive ingredients) are in ULORIC? | ULORIC excipients list |
DailyMed Link: | ULORIC at DailyMed |
Recent Clinical Trials for ULORIC
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ai Peng | N/A |
GenX Laboratories Inc. | Phase 2 |
Clinical Laboratory: USA | Phase 2 |
Pharmacology for ULORIC
Drug Class | Xanthine Oxidase Inhibitor |
Mechanism of Action | Xanthine Oxidase Inhibitors |
Paragraph IV (Patent) Challenges for ULORIC
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 ULORIC
ULORIC is protected by three US patents.
Patents protecting ULORIC
Solid preparation containing single crystal form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for concomitant treatment of theophylline and febuxostat
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE
Methods for concomitant treatment of theophylline and febuxostat
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE
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 | 021856-001 | Feb 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for ULORIC
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ULORIC
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 |
International Patents for ULORIC
See the table below for patents covering ULORIC around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Guatemala | 199900216 | POLIMORFOS DE ACIDO 2-(3-CIANO-4-ISOBUTILOXIFENIL)-4-METIL-5-TIAZOL CARBOXILICO Y METODO DE PRODUCCION DE LOS MISMOS. | ⤷ Sign Up |
Czech Republic | 20000582 | ⤷ Sign Up | |
South Korea | 20040101284 | ⤷ Sign Up | |
South Korea | 100221041 | ⤷ Sign Up | |
Japan | 2725886 | ⤷ Sign Up | |
Singapore | 86971 | 2-ARYLTHIAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITION THEREOF | ⤷ Sign Up |
China | 103298466 | Methods for concomitant treatment of theophylline and febuxostat | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULORIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1020454 | 19/2010 | Austria | ⤷ Sign Up | PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
1488790 | C20140037 00152 | Estonia | ⤷ Sign Up | PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008 |
1020454 | SPC015/2010 | Ireland | ⤷ Sign Up | SPC015/2010: 20101001, EXPIRES: 20230420 |
1020454 | C300447 | Netherlands | ⤷ Sign Up | PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
1020454 | 10C0022 | France | ⤷ Sign Up | PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
1020454 | CR 2010 00015 | Denmark | ⤷ Sign Up | PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421 |
1020454 | PA2010005,C1020454 | Lithuania | ⤷ Sign Up | PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004, 0080421 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |