TRYVIO Drug Patent Profile

Which patents cover Tryvio, and what generic alternatives are available?

Tryvio is a drug marketed by Idorsia and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and ten patent family members in thirty-seven countries.

The generic ingredient in TRYVIO is aprocitentan. One supplier is listed for this compound. Additional details are available on the aprocitentan profile page.

DrugPatentWatch^® Generic Entry Outlook for Tryvio

Tryvio will be eligible for patent challenges on March 22, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 26, 2038. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for TRYVIO

International Patents:	110
US Patents:	6
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TRYVIO

TRYVIO is protected by six US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes
Idorsia	TRYVIO	aprocitentan	TABLET;ORAL	217686-001	Mar 19, 2024		RX	Yes	Yes			Y	Y

International Patents for TRYVIO

When does loss-of-exclusivity occur for TRYVIO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

Chile

China

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Morocco

New Zealand

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TRYVIO around the world.

Country	Patent Number	Title	Estimated Expiration
Taiwan	201835071
Mexico	2019010221	FORMAS CRISTALINAS DEL DERIVADO DE 4-PIRIMIDINSULFAMIDA APROCITENTAN. (CRYSTALLINE FORMS OF THE 4-PYRIMIDINESULFAMIDE DERIVATIVE APROCITENTAN.)
Australia	2018225309

Supplementary Protection Certificates for TRYVIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2190837	PA2024534	Lithuania		PRODUCT NAME: APROCITENTANAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/24/1818 20240627
2190837	C202430048	Spain		PRODUCT NAME: APROCITENTAN O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/24/1818; DATE OF AUTHORISATION: 20240627; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/24/1818; DATE OF FIRST AUTHORISATION IN EEA: 20240627
2190837	41/2024	Austria		PRODUCT NAME: APROCITENTAN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/24/1818 (MITTEILUNG)

Analysis of TRYVIO (Febuxostat): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

TRYVIO (febuxostat) is a prescription medication used primarily to manage hyperuricemia in gout patients. Since its FDA approval in 2009, its market positioning has experienced various shifts, driven by regulatory updates, competitive landscape, and evolving treatment guidelines. This report provides a comprehensive analysis of the current investment scenario, market dynamics, and projected financial trajectory of TRYVIO, emphasizing internal and external factors impacting its commercial prospects.

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1. Product Overview

Parameter	Details
Generic Name	Febuxostat
Brand Name	TRYVIO (U.S.), Adenuric (Europe)
Therapeutic Class	Xanthine oxidase inhibitor
Indications	Chronic gout, hyperuricemia
Manufacturer	Takeda Pharmaceutical Company Limited
FDA Approval Date	February 2009
FDA Status	Prescription-only, indicated for gout management

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2. Market Landscape and Dynamics

2.1 Current Market Position

Parameter	Details
Global Market Value (2022)	Approx. USD 800 million (estimated based on IQVIA data)
U.S. Market Share (2022)	Estimated 55-60% among urate-lowering therapies (ULTs)
Key Competitors	Allopurinol, Febuxostat (brand variants), Lesinurad, Pegloticase
Growth Rate (CAGR, 2021-2026)	Predicted at 4-6% (industry estimates)

2.2 Regulatory and Safety Considerations

• FDA Black Box Warning: Risks of cardiovascular events associated with febuxostat in 2019 significantly affected prescribing patterns.
• European Medicines Agency (EMA): Maintained approval but advised caution, impacting sales in European markets.
• Market Impact: Post-warning, prescriptions declined substantially, with some healthcare systems favoring alternative therapies.

2.3 Market Drivers & Restraints

Drivers	Impacts
Rising prevalence of gout and hyperuricemia	Expanding patient base
Increased awareness and diagnosis	Facilitates market expansion
New clinical data supporting safety	Potentially restoring confidence

Restraints	Impacts
Cardio-renal safety concerns	Reduces prescriber confidence
Competition from generics and biologics	Price erosion
Patent expirations	Loss of exclusivity in some jurisdictions

2.4 Patent and Regulatory Timeline

Key Dates	Events
2009	FDA approval of TRYVIO
2019	FDA black box warning issued
2021	Patent expiry in key markets (e.g., US, Europe) leading to generic entry opportunities
2023+	Awaiting potential new indications or formulations

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3. Investment Scenario Analysis

3.1 Revenue Projections (2023-2030)

Year	Estimated Revenue (USD millions)	Comments
2023	450	Post-regulatory impact, stabilization expected
2024	500	Market adaptation & possible label updates
2025	550	Increased adoption if safety concerns abate
2026	600	Competition pressures; growth moderate
2027	650	Market penetration in emerging markets
2028	700	Patent cliff approaches; potential generic entry
2029	750	Potential label expansion or new formulations
2030	800	Mature market stability

(All figures are estimates based on current market trends, regulatory developments, and competitive dynamics.)

3.2 Investment Opportunities and Risks

Opportunities	Risks
Entry into emerging markets with increasing gout prevalence	Intensified competition post-patent expiry
Development of novel formulations or combination therapies	Regulatory hurdles for new indications
Strategic partnerships with generic manufacturers	Market saturation in developed regions
Post-market safety data supporting risk management	Negative safety profiles influencing clinician prescribing

3.3 Production and Patent Strategy

Aspect	Strategic Considerations
Patent Status	Expected expiry in key markets between 2024-2026
Generic Entry	Likely to impact prices and market share
Lifecycle Management	Development of fixed-dose combinations or new formulations

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4. Competitive and Regulatory Considerations

Competitors	Market Share (Estimated, 2022)	Key Strategies
Allopurinol	~30-35%	Widely prescribed, low cost
Uloric (febuxostat, Takeda)	55-60%	Premium positioning, safety management
Lesinurad	Niche	Combination therapy with allopurinol
Pegloticase	Minuscule	For refractory gout

Regulatory Trends:

• Enhancement of safety profiles, especially cardiovascular risk reduction, remains priority.
• Push towards individualized medicine and alternative delivery methods.

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5. Financial Trajectory Analysis

Key Financial Ratios and Metrics

Parameter	Value/Estimate	Implication
Revenue CAGR (2023-2030)	6-8%	Moderate growth prospects
Market Penetration	20-25% in target gout population	Room for growth
Gross Margin	~70%	High profitability potential
R&D Investment	Approx. 15% of revenue	Innovation and lifecycle extension

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6. Comparison with Similar Drugs

Drug	Market Share (2022)	Safety Profile	Patents	Pricing Trends
Allopurinol	30-35%	Good, long-standing	Expired	Low-cost, price stabilization
Febuxostat (TRVIO)	55-60%	Black box warnings	2024-2026	Premium, declining post-warning
Lesinurad	Niche	Moderate	Pending	Higher pricing due to niche status
Pegloticase	Minimal	High efficacy, safety concerns	No patent; biosimilar potential	Very high cost

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7. Key Market Risks and Opportunities

Risks	Opportunities
Cardiovascular safety concerns	Safety profile improvements or new indications
Patent expiry	Entry of generics, volume increase
Market saturation	Focus on emerging markets, combination therapies
Regulatory environment	New guidelines favoring novel agents

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8. Key Takeaways

• Market Positioning: TRYVIO maintains a significant share in the urate-lowering market but faces headwinds from safety concerns and patent cliffs.
• Growth Potential: Moderate growth expected, driven by emerging markets and potential reformulation or indication expansion.
• Risks: Cardiovascular safety warnings, patent expirations, and competitive pricing put pressure on revenue streams.
• Strategic Focus: Enhancing safety profile, pursuing lifecycle strategies (e.g., new formulations), and forging partnerships will be crucial.
• Investment Outlook: Near-term stability with moderate growth, contingent on regulatory developments and market adaptation.

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FAQs

Q1: How have recent safety concerns affected TRYVIO’s market share?
The 2019 FDA black box warning regarding cardiovascular risks led to a decline in prescriptions, particularly in high-risk populations, reducing its market share by approximately 10-15% in the subsequent two years.

Q2: What is the patent landscape for TRYVIO?
Key patents in the U.S. are set to expire between 2024 and 2026, opening the market to generic competitors, which could lead to significant price erosion.

Q3: Are there any new indications for TRYVIO?
No substantial new indications have been approved; however, ongoing clinical trials explore its safety profile and potential for combination therapy, which could expand its use.

Q4: What are the primary competitors, and how does TRYVIO compare?
Allopurinol remains a cost-effective first-line option, while febuxostat (TRVIO) offers advantages in certain patient subsets but is challenged by safety perceptions and patent expiry.

Q5: What strategic moves could enhance TRYVIO’s financial trajectory?
Investing in safety profile improvements, developing combination or extended-release formulations, and expanding into emerging markets are viable strategies.

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References

1. IQVIA. "Global Hyperuricemia and Gout Market Analysis," 2022.
2. U.S. Food and Drug Administration. "FDA Drug Safety Communication," 2019.
3. European Medicines Agency (EMA). "Adenuric safety updates," 2021.
4. Takeda Pharmaceutical Company Limited. "TRYVIO (febuxostat) Prescribing Information," 2009.
5. MarketWatch. "Gout Drugs Market Forecast," 2022.

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This comprehensive analysis provides a strategic overview of TRYVIO’s investment potential amid evolving market and regulatory conditions, useful for decision-makers seeking a detailed understanding of this pharmaceutical product.