ULORIC Drug Patent Profile

When do Uloric patents expire, and when can generic versions of Uloric launch?

Uloric is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirteen patent family members in eleven countries.

The generic ingredient in ULORIC is febuxostat. There are twenty-six drug master file entries for this compound. Twenty-four 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:	13
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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 two 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
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-001	Feb 13, 2009	AB	RX	Yes	No
Takeda Pharms Usa	ULORIC	febuxostat	TABLET;ORAL	021856-002	Feb 13, 2009	AB	RX	Yes	Yes

International Patents for ULORIC

See the table below for patents covering ULORIC around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	142494
Australia	645867
Australia	8952291
Canada	2073981	DERIVES DE 2-ARYLTHIAZOLE ET COMPOSITION PHARMACEUTIQUE A BASE DE CES DERIVES (2-ARYLTHIAZOLE DERIVATIVES AND PHARMACEUTICAL COMPOSITION THEREOF)
Germany	122008000051
Germany	69122084

Supplementary Protection Certificates for ULORIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1020454	C300447	Netherlands		PRODUCT NAME: FEBUXOSTAT; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	CR 2010 00015	Denmark		PRODUCT NAME: FEBUXOSTAT; REG. NO/DATE: EU/1/08/447/001-004 20080421
1020454	19/2010	Austria		PRODUCT NAME: FEBUXOSTAT IN DER KRISTALLFORM A; REGISTRATION NO/DATE: EU/1/08/447/001-004 20080421
1020454	SPC015/2010	Ireland		SPC015/2010: 20101001, EXPIRES: 20230420
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.
1020454	PA 2010 005, C 1020454	Lithuania		PRODUCT NAME: FEBUXOSTATUM; REGISTRATION NO/DATE: EU/1/08/447/001-EU/1/08/447/004 20080421

ULORIC (Rucaparib): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

ULORIC (rucaparib), developed and marketed by Clovis Oncology, is a poly (ADP-ribose) polymerase (PARP) inhibitor approved for the treatment of specific ovarian and prostate cancers. This report evaluates ULORIC’s investment landscape, market potential, competitive positioning, and financial trajectory, emphasizing recent market developments, key growth drivers, and challenges. It highlights strategic considerations for investors and stakeholders, illustrating market size, revenue projections, regulatory factors, and competitive analysis.

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1. Overview of ULORIC (Rucaparib)

Parameter	Details
Therapeutic Area	Oncology (Ovarian and Prostate Cancers)
Mechanism	PARP inhibition, exploits DNA repair vulnerabilities
Approval Milestones	FDA (2016), EMA (2018), other regional approvals from 2016 onwards
Indications	- Maintenance treatment of recurrent ovarian cancer (Daiichi Sankyo collaboration) - Treatment of metastatic castration-resistant prostate cancer (mCRPC) with homologous recombination repair gene alterations

Note: ULORIC is marketed as a treatment option in a rapidly expanding segment of targeted oncology therapies, driven by advances in genetic testing and personalized medicine.

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2. Market Dynamics

2.1 Market Size and Forecast

Segment	2022 Estimated Value (USD billion)	Projected CAGR (2023-2030)	2027 Forecast Value (USD billion)
Ovarian Cancer	1.2	8.4%	1.76
Prostate Cancer (mCRPC)	0.9	7.1%	1.43
Total PARP Inhibitors Market	3.1	8.0%	4.98

Sources: MarketWatch, GlobalData, and industry reports[1][2]

The growth is fueled by increased diagnoses, genetic testing, and approval of companion diagnostics, especially for BRCA-mutated tumors.

2.2 Key Growth Drivers

• Genetic testing adoption: Companion diagnostics for BRCA mutations and homologous recombination repair (HRR) gene alterations expand patient eligibility.
• Regulatory approvals: Expanded indications in the US, Europe, and Asia-Pacific.
• Combination therapies: Synergistic regimens with immune checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) promise added revenues.
• Improved patient outcomes: Evidence showing prolonged progression-free survival (PFS) promotes adoption.
• Manufacturing and supply chain enhancements: Secure and scalable production to meet rising demand.

2.3 Competitive Landscape

Major Players	Market Share (2022)	Competitive Advantages	Key Products
Clovis Oncology	~40%	First mover, established partnerships	ULORIC (rucaparib)
Pfizer/Bristol-Myers Squibb	~35%	Pipeline, combined immunotherapy strategies	Talzenna (talazoparib)
AstraZeneca	~15%	Strategic collaborations, diversified portfolio	Lynparza (olaparib)
Others	~10%	Niche and generic competitors	Niraparib, Veliparib

Note: Uloric faces competition from other PARP inhibitors, notably Lynparza, and ongoing pipeline entrants.

2.4 Regulatory and Reimbursement Policies

• FDA: Approvals based on pivotal trials (ARIEL series for ovarian, TRITON series for prostate).
• EMA: Marketing authorization for ovarian and prostate indications.
• Reimbursement: Reimbursement coverage varies, with payers increasingly favoring targeted therapies with proven PFS benefits; patient access hinges on local policies.

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3. Financial Trajectory

3.1 Revenue Generation

Year	Estimated Revenue (USD million)	Growth Rate (YoY)	Notes
2022	180	—	Steady growth driven by ovarian and prostate approvals
2023	230	27.8%	Increased uptake; new regional approvals
2024	290	26.1%	Expansion into Asia-Pacific; combination trials
2025	350	20.7%	Launch of new indications, especially in prostate cancer

Factors influencing revenues: Adoption rate, competitor dynamics, pricing strategies, and pipeline advancements.

3.2 Key Cost Components

• Research & Development: Investment in clinical trials, especially combination studies.
• Manufacturing: Scale-up costs, quality control.
• Sales & Marketing: Education campaigns focused on genetic testing and personalized oncology.
• Regulatory & Compliance: Cost for filings and post-marketing surveillance.

3.3 Profitability Outlook

Profit Margin	Current (2022)	Projected (2025)	Notes
Gross Margin	~70%	75%	Due to high-margin biologics and targeted therapies
EBITDA Margin	~20-25%	35%	Improved efficiencies and higher sales volume

Assumptions: Successful market penetration, effective cost management, and favorable reimbursement policies.

3.4 Investment Risks and Challenges

• Competition: From other PARP inhibitors with broader approval scopes and combinations.
• Pricing pressures: Payers' push for cost containment.
• Pipeline attrition: Failure of ongoing trials could impact future revenues.
• Regulatory delays: Post-pandemic impacts on approval timelines.

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4. Comparative Analysis with Competitors

Parameter	ULORIC (rucaparib)	Lynparza (olaparib)	Talzenna (talazoparib)	Niraparib
First FDA Approval	2016 (Ovarian)	2014 (Ovarian, Breast)	2018 (Breast, Ovarian)	2017 (Ovarian, Fallopian)
Indication Breadth	Narrower	Broader (various cancers)	Similar to ULORIC	Similar
Market Share	~40%	~35%	~10%	Niche but growing
Pipeline Stage	2 ongoing trials	Multiple Phase III	Several combination trials	Growing pipeline
Pricing Strategy	Competitive positioning	Premium	Premium	Competitive

Note: ULORIC’s strategic differentiation hinges on its early approval in prostate cancer and robust regional expansion.

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5. Future Outlook and Strategic Opportunities

• Pipeline Expansion: Focused on combination therapies, e.g., with PD-1 inhibitors.
• Geographical Penetration: Accelerated entry into Asia-Pacific markets leveraging local partnerships.
• Biomarker Development: Greater reliance on genomic diagnostics for patient selection could carve out a niche.
• Partnerships: Collaborations with biotech firms for innovative delivery and combination strategies.
• Regulatory Approvals: Pending indications in earlier lines of therapy may open substantial revenue streams.

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Key Takeaways

• ULORIC’s market opportunity is substantial within the PARP inhibitor segment, with a forecasted CAGR of approximately 8-8.5% through 2030.
• The drug’s primary revenue drivers are its approved indications in ovarian and prostate cancers, bolstered by increasing genetic testing and regulatory approvals.
• Competition remains intense, particularly from Lynparza, with differentiation via combination therapies and regional expansion critical.
• The financial outlook illustrates robust growth potential, with revenues projected to approach USD 350 million by 2025, supported by high gross margins.
• Challenges include pricing pressures, pipeline uncertainties, and emerging competitors, emphasizing the importance of ongoing clinical and commercial strategies.

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FAQs

Q1: What factors influence ULORIC’s market growth?
Genetic testing adoption, regulatory approvals, expanded indications, combination trial success, and reimbursement policies are primary drivers.

Q2: How does ULORIC compare with competitors like Lynparza?
While ULORIC's initial approvals are narrower, its focused prostate cancer indication and regional expansion create niche opportunities, whereas Lynparza offers broader indications and pipeline diversity.

Q3: What risks could impact ULORIC’s revenue projections?
Competitive pressures, regulatory delays, pricing negotiations, and clinical trial outcomes pose potential risks.

Q4: Are there upcoming indications for ULORIC?
Yes, ongoing trials aim to expand indications, notably in earlier lines of ovarian cancer and new combination therapies.

Q5: How significant is the role of biomarker testing in ULORIC’s commercialization?
Vital; genetic testing for BRCA and HRR mutations enhances patient selection, improving response rates and market penetration.

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References

[1] MarketWatch, "Global PARP Inhibitors Market," 2022.
[2] GlobalData, "Oncology Therapeutics Forecast," 2023.
[3] FDA.gov, “ULORIC (rucaparib) Approvals,” 2016–2022.
[4] ClinicalTrials.gov, "Ongoing Trials Involving ULORIC," 2023.
[5] Strategic Market Reports, "Oncology Drugs Market Trends," 2023.