ULORIC Drug Patent Profile

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 1^st, 2019.

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:	634
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

See drug prices for ULORIC

See drug sales revenues for ULORIC

Recent Clinical Trials for ULORIC

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

Sponsor	Phase
Ai Peng	N/A
Covance Bioanalytical Services, LLC	Phase 2
Analytical Laboratory (Pharmacokinetic Sample Analysis): USA	Phase 2

See all ULORIC clinical trials

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.

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	9,107,912
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	8,372,872
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	8,372,872
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No	7,361,676		Y
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes	7,361,676		Y

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	5,614,520
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	5,614,520
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	6,225,474
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	7,361,676
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	6,225,474

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

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
Hungary	9202265
Slovenia	1956015
Iceland	2886
Spain	2505690

Supplementary Protection Certificates for ULORIC

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

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.