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-two 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.
Summary for ULORIC
| International Patents: | 28 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 139 |
| Clinical Trials: | 27 |
| Patent Applications: | 735 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ULORIC |
| Drug Sales Revenues: | Drug sales revenues 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 |
| Harbor Hospital Laboratory | Phase 2 |
| Contract Research Organization: USA | Phase 2 |
Pharmacology for ULORIC
| Drug Class | Xanthine Oxidase Inhibitor |
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ULORIC
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for concomitant treatment of theophylline and febuxostat
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-001 | Feb 13, 2009 | AB | RX | Yes | 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Takeda Pharms Usa | ULORIC | febuxostat | TABLET;ORAL | 021856-002 | Feb 13, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Hungary | 0004325 | ⤷ Try a Trial | |
| Norway | 321308 | ⤷ Try a Trial | |
| Austria | 522512 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULORIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1020454 | C300447 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421 |
| 1488790 | C20140037 00152 | Estonia | ⤷ Try a Trial | PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008 |
| 1020454 | PA2010005,C1020454 | Lithuania | ⤷ Try a Trial | 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 |
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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 verification 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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