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Last Updated: December 22, 2024

ULORIC Drug Patent Profile


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When do Uloric patents expire, 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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Drug patent expirations by year for ULORIC
Drug Prices for ULORIC

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Drug Sales Revenue Trends for ULORIC

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Recent Clinical Trials for ULORIC

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ai PengN/A
Harbor Hospital LaboratoryPhase 2
Contract Research Organization: USAPhase 2

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Pharmacology 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.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 AB RX Yes No ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 021856-002 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-001 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ULORIC febuxostat TABLET;ORAL 021856-002 Feb 13, 2009 ⤷  Subscribe ⤷  Subscribe
>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
China 103298466 Methods for concomitant treatment of theophylline and febuxostat ⤷  Subscribe
Hungary 9202265 ⤷  Subscribe
Slovenia 1956015 ⤷  Subscribe
Iceland 2886 ⤷  Subscribe
Spain 2505690 ⤷  Subscribe
Hungary 218942 2-Fenil-tiazol-származékok, az ezeket tartalmazó gyógyászati készítmények, valamint eljárás a vegyületek előállítására (2-PHENYLTHIAZOLE DERIVATIVES, PHARMACEUTICAL COMPOSITIONS CONTAINING THEM, AND PROCESS FOR THE PREPARATION OF THE COMPOUNDS) ⤷  Subscribe
Canada 2073981 DERIVES DE 2-ARYLTHIAZOLE ET COMPOSITION PHARMACEUTIQUE A BASE DE CES DERIVES (2-ARYLTHIAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITION THEREOF) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ULORIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1020454 91682 Luxembourg ⤷  Subscribe 91682, EXPIRES: 20230421
1488790 C20140037 00152 Estonia ⤷  Subscribe PRODUCT NAME: FEBUKSOSTAAT;REG NO/DATE: EU/1/08/447 23.04.2008
1020454 SPC015/2010 Ireland ⤷  Subscribe SPC015/2010: 20101001, EXPIRES: 20230420
1020454 PA2010005 Lithuania ⤷  Subscribe PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421
1020454 SPC/GB10/019 United Kingdom ⤷  Subscribe 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 10C0022 France ⤷  Subscribe PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454 CR 2010 00015 Denmark ⤷  Subscribe PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

ULORIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Uloric (Febuxostat)

Introduction

Uloric, also known as febuxostat, is a medication developed by Takeda Pharmaceuticals to treat gout in adults. Since its approval in 2009, Uloric has navigated a complex landscape of market dynamics and financial performance, significantly influenced by safety concerns and regulatory actions.

Approval and Initial Market Performance

Uloric was approved by the FDA in 2009 after two previous failed attempts in 2005 and 2006 due to cardiovascular safety issues. Despite these initial hurdles, Uloric quickly gained traction in the market, particularly in the U.S., where it was one of the growing drugs in Takeda’s portfolio. In the nine months ending in December 2018, Uloric generated 40.5 billion Japanese yen ($366 million), a 15.7% increase year over year[1].

Safety Concerns and Regulatory Actions

A significant turning point in Uloric's market dynamics came with the results of a large postmarketing safety study known as the CARES trial. This trial, which involved over 6,000 patients, revealed an increased risk of cardiovascular deaths and deaths from all causes associated with Uloric compared to allopurinol, a traditional gout medication[2][3][4].

In response to these findings, the FDA added a boxed warning to Uloric's label in February 2019, highlighting the increased risk of death. The agency also limited the approved use of Uloric to patients who have failed or do not tolerate allopurinol. This decision significantly impacted Uloric's market position, restricting its use to a smaller patient population[3][4].

Impact on Sales and Market Share

The FDA's actions had a profound impact on Uloric's sales and market share. Prior to the boxed warning, Uloric was a first-line treatment option for gout patients. However, with the new restrictions, its use was relegated to second-line treatment, which reduced its potential market size. The drug's growth, which had been robust, was put in jeopardy as a result of these regulatory changes[1].

Generic Competition

Another factor affecting Uloric's market dynamics is the introduction of generic versions. Dr. Reddy's Laboratories, for example, launched a generic version of febuxostat in the U.S. market in January 2021. This competition further eroded Uloric's market share and revenue. The Uloric brand and generic had U.S. sales of approximately $108 million for the twelve months ending in October 2020, indicating a decline from its peak[5].

Financial Trajectory

Uloric's financial performance has been closely tied to its market dynamics. Before the FDA's safety warnings, Uloric was a significant contributor to Takeda's revenue, especially in the U.S. market. However, following the regulatory actions, the drug's sales began to decline.

  • Pre-2019: Uloric was experiencing growth, with sales increasing by 15.7% year over year in the nine months ending in December 2018[1].
  • Post-2019: The imposition of the boxed warning and the restriction to second-line use led to a decline in sales. The exact financial impact is evident in the reduced market share and the introduction of generic competition, which further diminished Uloric's revenue.

Market Need and Competition

Despite the challenges, there remains an unmet need for effective gout treatments. Gout affects approximately 8.3 million adults in the U.S., and the number of available treatments is limited. However, Uloric now faces stiff competition from both allopurinol and generic versions of febuxostat, making it harder to regain its previous market position[4].

Expert Insights and Public Reaction

The safety concerns surrounding Uloric have been a subject of discussion among healthcare professionals and consumer advocacy groups. For instance, William White of the University of Connecticut School of Medicine, the lead investigator of the postmarket study, noted that the imbalance in cardiovascular deaths between Uloric and allopurinol was unexpected and warranted further analysis[1].

Public Citizen, a nonprofit consumer advocacy group, called for the FDA to pull Uloric’s approval due to the increased risk of death associated with the drug[1].

Key Statistics

  • Sales: Uloric generated 40.5 billion Japanese yen ($366 million) in the nine months ending in December 2018[1].
  • Patient Population: Uloric is now limited to a smaller population of gout patients who have failed or do not tolerate allopurinol, out of approximately 8.3 million adult gout patients in the U.S.[1][4].
  • Mortality Rates: Uloric showed an increased risk of heart-related deaths (15 deaths per 1,000 patients per year) and deaths from all causes (26 deaths per 1,000 patients per year) compared to allopurinol (11 heart-related deaths and 22 deaths from all causes per 1,000 patients per year)[3].

Conclusion

The market dynamics and financial trajectory of Uloric have been significantly impacted by safety concerns and regulatory actions. From a promising growth trajectory to a restricted market position, Uloric's story highlights the critical importance of safety data and regulatory compliance in the pharmaceutical industry.

Key Takeaways

  • Uloric's approval and initial success were followed by significant safety concerns.
  • The FDA's boxed warning and restriction to second-line use severely impacted Uloric's market share and revenue.
  • Generic competition has further eroded Uloric's market position.
  • Despite challenges, there remains an unmet need for effective gout treatments.
  • Safety data and regulatory compliance are crucial for pharmaceutical market success.

FAQs

Q: What is Uloric, and how is it used? A: Uloric, also known as febuxostat, is a medication used to treat gout in adults by lowering uric acid levels in the blood.

Q: Why did the FDA add a boxed warning to Uloric's label? A: The FDA added a boxed warning due to an increased risk of heart-related deaths and deaths from all causes associated with Uloric compared to allopurinol, as revealed by a postmarketing safety study.

Q: How has the boxed warning affected Uloric's market position? A: The boxed warning has restricted Uloric's use to patients who have failed or do not tolerate allopurinol, significantly reducing its market share and revenue.

Q: What is the current market competition for Uloric? A: Uloric faces competition from allopurinol and generic versions of febuxostat, which have further diminished its market share.

Q: What are the implications of Uloric's safety concerns for patients? A: Patients should be counseled about the cardiovascular risk associated with Uloric and advised to seek medical attention immediately if they experience symptoms. Health care professionals should reserve Uloric for use only in patients who have failed or do not tolerate allopurinol.

Sources

  1. FiercePharma: Takeda gout drug Uloric loses first-line approval after FDA confirms safety risks.
  2. Takeda: Takeda Announces Results from Uloric® (febuxostat) Cardiovascular Outcomes Trial.
  3. FDA: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat).
  4. FDA: FDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat) - Podcast.
  5. Biospace: Dr. Reddy's Laboratories announces the launch of Febuxostat Tablets in the U.S. market.

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