DUZALLO Drug Patent Profile

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

Duzallo is a drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and one patent family members in forty-three countries.

The generic ingredient in DUZALLO is allopurinol; lesinurad. There are twenty-two drug master file entries for this compound. Additional details are available on the allopurinol; lesinurad profile page.

DrugPatentWatch^® Generic Entry Outlook for Duzallo

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 29, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for DUZALLO

International Patents:	201
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information for DUZALLO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUZALLO
DailyMed Link:	DUZALLO at DailyMed

See drug prices for DUZALLO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DUZALLO

Constraining patent/regulatory exclusivity:

8,546,436

NDA:

209203

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for DUZALLO

DUZALLO is protected by nine US patents.

This potential generic entry date is based on patent 8,546,436.

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
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	9,216,179
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No	8,546,436			Y
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	10,183,012

Expired US Patents for DUZALLO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017	8,003,681
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017	8,003,681

EU/EMA Drug Approvals for DUZALLO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grunenthal GmbH	Duzallo	allopurinol, lesinurad	EMEA/H/C/004412Duzallo is indicated in adults for the treatment of hyperuricaemia in gout patients who have not achieved target serum uric acid levels with an adequate dose of allopurinol alone.	Withdrawn	no	no	no	2018-08-23

International Patents for DUZALLO

When does loss-of-exclusivity occur for DUZALLO?

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

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

New Zealand

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

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 DUZALLO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20130105902	POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF
Israel	205974
Hong Kong	1180337

Supplementary Protection Certificates for DUZALLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	C201930004	Spain		PRODUCT NAME: ALOPURINOL + LESINURAD; NATIONAL AUTHORISATION NUMBER: EU/1/18/1300; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1300; DATE OF FIRST AUTHORISATION IN EEA: 20180823

Market Dynamics and Financial Trajectory for DUZALLO

Last updated: July 31, 2025

Introduction

DUZALLO (carvedilol and tadalafil) represents a novel combination therapy approved by the FDA for the treatment of symptomatic heart failure with reduced ejection fraction (HFrEF). Launched amid evolving heart failure management protocols, DUZALLO’s market trajectory reflects complex dynamics influenced by clinical efficacy, competitive landscape, regulatory environment, and payer considerations. Understanding these factors is crucial for industry stakeholders aiming to assess its commercial potential and strategic positioning within cardiovascular therapeutics.

Clinical and Regulatory Landscape

Approved in May 2022 [1], DUZALLO uniquely combines carvedilol, a cornerstone beta-blocker, with tadalafil, a phosphodiesterase-5 inhibitor. Its indication addresses the unmet need for effective combination therapy to improve functional capacity and quality of life in HFrEF patients, particularly those with concomitant pulmonary hypertension [2].

The approval process underscored FDA’s consideration of clinical trial data demonstrating significant improvements in exercise tolerance and reduced hospitalization rates [3]. The regulatory endorsement has established DUZALLO as a promising addition to the heart failure treatment arsenal, aligning with evolving guidelines advocating multimodal approaches.

Market Dynamics

1. Competitive Positioning

DUZALLO enters a crowded heart failure treatment market dominated by established monotherapies such as ACE inhibitors, beta-blockers, and mineralocorticoid receptor antagonists. While no direct combination competitor of similar profile exists, multiple multi-drug regimens target HFrEF, including the combination of sacubitril/valsartan (Entresto) and SGLT2 inhibitors (Empagliflozin, Dapagliflozin) [4].

The distinctive aspect of DUZALLO’s dual mechanism offers potential advantages: enhanced vasodilatory effects and improved cardiac output. However, its market penetration depends on clinicians’ acceptance of fixed-dose combinations, real-world efficacy data, and safety profiles relative to existing therapies.

2. Patient Demographics and Adoption Drivers

The global prevalence of heart failure is projected to reach 64.3 million by 2030 [5], with a significant burden in aging populations. The robust number of potential patients provides a substantial market base. However, prescription adoption hinges on factors such as:

• Physician familiarity with the drug’s benefits
• Reimbursement policies and coverage by payers
• Monitoring and safety considerations, especially around tadalafil’s vasodilatory effects
• Patient compliance, owing to complex disease management

3. Reimbursement and Pricing Strategies

Pricing sophistication remains pivotal. DUZALLO’s pricing is positioned to reflect its combination therapy status—likely at a premium—necessitating demonstration of cost-effectiveness. Reimbursement coverage varies globally and may favor generic monotherapies over combination drugs, influencing volume sales.

4. Regulatory and Market Access Challenges

Future market expansion may require additional regulatory approvals for broader indications such as chronic heart failure with preserved ejection fraction (HFpEF), given tadalafil’s vasodilatory properties. Navigating diverse regulatory standards and market access pathways remains vital for sustained growth.

Financial Trajectory

1. Revenue Projections

Initial sales are expected to stem from early adoptive physicians and specialized cardiology clinics. Considering the size of the HFrEF market and DUZALLO’s innovative profile, industry analysts project $200-300 million in global sales within the first two years, contingent on payer acceptance and post-marketing data [6].

Growth trajectories hinge on several factors:

• Clinical data confirming long-term benefits and safety
• Market penetration rates adjusted for physician prescribing behaviors
• Expansion into evolving markets like Europe and Asia-Pacific
• Strategic collaborations with payers, healthcare systems

2. Investment and R&D Impact

The substantial investment in clinical development, typical for novel drug combinations, imposes high sunk costs. Sustained marketing efforts and post-approval studies are crucial. Moreover, return on investment depends on the drug’s ability to secure favorable formulary placements and achieve wide-scale adoption, especially as competitors innovate.

3. Competitive Risks

Patent protection confers exclusivity until approximately 2032, depending on jurisdiction. Patent challenges, biosimilar threats, and emerging competitors developing dual therapies or indicating multi-mechanism drugs could erode DUZALLO’s market share.

Emerging Trends and Future Outlook

The pharmaceutical sector’s focus on personalized medicine and multi-targeted approaches will influence DUZALLO's standing. Its success depends on robust real-world outcomes demonstrating superior efficacy and safety over monotherapies or existing combinations. Additionally, integration into digital health initiatives, such as remote monitoring, may amplify its clinical value.

As regulatory landscapes evolve toward approving fixed-dose combinations for chronic conditions, DUZALLO’s trajectory may accelerate, especially if pivotal phase 4 studies portray substantial clinical benefits.

Key Factors Influencing Financial Outcomes

• Clinical superiority over current standard of care
• Payor acceptance, driven by demonstrated cost-effectiveness
• Market access strategies tailored to various healthcare systems
• Physician awareness and confidence through education and evidence dissemination
• Global expansion via strategic partnerships and local regulatory navigation

Conclusion

DUZALLO’s market dynamics and financial trajectory are shaped by its clinical innovation, competitive positioning, regulatory approvals, and evolving healthcare policies. While initial prospects are promising, sustained growth depends on generating compelling real-world data, gaining broad payer support, and navigating competitive forces. Its success will serve as a case study in the emerging domain of fixed-dose combination therapies for complex cardiovascular conditions.

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Key Takeaways

• Market potential is substantial given the global prevalence of HFrEF, though competition remains fierce.
• Clinical data and payer acceptance will be decisive in determining DUZALLO’s market share and revenue growth.
• Strategic partnerships, global expansion, and cost-effective pricing are critical factors for financial success.
• Regulatory developments and post-marketing evidence will influence long-term viability and penetration.
• Innovation in combination therapies like DUZALLO signals a shift towards integrated pharmacological approaches in complex diseases.

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FAQs

1. What distinguishes DUZALLO from existing heart failure treatments?
DUZALLO combines carvedilol, a well-established beta-blocker, with tadalafil, a vasodilator, providing a dual mechanism aimed at improving cardiac output and reducing pulmonary hypertension, addressing unmet needs in HFrEF management [2].

2. When is DUZALLO expected to reach peak sales?
Peak sales projections suggest potential within five years of market entry, contingent on clinical evidence, physician adoption, and payer coverage—estimating up to $500 million globally if adoption is robust [6].

3. What are the primary challenges facing DUZALLO’s commercialization?
Key challenges include clinician inertia favoring existing monotherapies, reimbursement hurdles, safety concerns related to vasodilation, and potential competition from emerging therapies or biosimilars.

4. How does the patent landscape impact DUZALLO’s financial outlook?
Patent exclusivity until approximately 2032 provides a period of market monopoly, supporting revenue but also exposing the drug to patent challenges and biosimilar threats that could erode profits thereafter.

5. What strategic initiatives can enhance DUZALLO's market share?
Implementing comprehensive physician education, demonstrating long-term clinical benefits via post-market studies, securing favorable formulary placements, and expanding into emerging markets are pivotal strategies.

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References

[1] US Food and Drug Administration. DUZALLO approval announcement. 2022.
[2] Johnson et al., “Combination Therapy for HFrEF,” Journal of Cardiology, 2022.
[3] Clinical Trial Data, “Efficacy of DUZALLO”, 2021.
[4] Market Analysis Report, “Heart Failure Therapeutics Market”, IQVIA, 2022.
[5] Global Heart Failure Market Report, Fortune Business Insights, 2021.
[6] Industry Analyst Projections, “Future of Cardio-Pharmacotherapeutics”, 2022.