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 patent family members in forty-two 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.

Indicators of Generic Entry

Summary for DUZALLO

International Patents:	200
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Drug Prices:	Drug price information 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
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No	8,283,369

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/004412 Duzallo 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
Japan	2015172053	２−（５−ブロモ−４−（４−シクロプロピルナフタレン−１−イル）−４Ｈ−１，２，４−トリアゾル−３−イルチオ）酢酸の多形形態およびその使用 (POLYMORPHIC FORMS OF 2-(5-BROMO-4-(4-CYCLOPROPYLNAPHTHALEN-1-YL)-4H-1,2,4-TRIAZOL-3-YLTHIO)ACETIC ACID AND USES THEREOF)
Hungary	E038265
South Korea	20090111357	S-TRIAZOLYL ?-MERCAPTOACETANILIDES AS INHIBITORS OF HIV REVERSE TRANSCRIPTASE
Brazil	PI0918584	compostos, composicoes e metodos de uso dos mesmos para modulacao dos niveis de acido urico

Supplementary Protection Certificates for DUZALLO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	PA2019003	Lithuania		PRODUCT NAME: ALOPURINOLIS/LESINURADAS ARBA JO FRAMACINIU POZIURIU PRIIMTINA DRUSKA ARBA DRUSKOS; REGISTRATION NO/DATE: EU/1/18/1300 20180823
2217577	CA 2019 00003	Denmark		PRODUCT NAME: DUZALLO - ALLOPURINOL/LESINURAD OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SALTS THEREOF; REG. NO/DATE: EU/1/18/1300 20180827
2135608	CA 2016 00034	Denmark		PRODUCT NAME: LESINURAD ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU1/15/1080 20160222
2135608	C 2016 027	Romania		PRODUCT NAME: LESINURAD SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1080; DATE OF NATIONAL AUTHORISATION: 20160218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1080; DATE OF FIRST AUTHORISATION IN EEA: 20160218

DUZALLO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DUZALLO

Introduction to DUZALLO

DUZALLO, a groundbreaking drug developed by Ironwood Pharmaceuticals, is the first FDA-approved fixed-dose combination treatment for hyperuricemia associated with gout. It combines lesinurad and allopurinol, addressing both the overproduction and underexcretion of serum uric acid, the underlying causes of hyperuricemia[1][4].

Market Need and Target Population

Gout is a highly symptomatic and painful form of inflammatory arthritis, affecting a significant population. DUZALLO is specifically designed for patients whose serum uric acid levels are not adequately controlled with allopurinol or other xanthine oxidase inhibitors alone. This patient population is estimated to be around two million in the U.S., highlighting a substantial unmet need in the market[1][4].

Mechanism of Action and Clinical Efficacy

DUZALLO's dual mechanism of action sets it apart from other treatments. Allopurinol, a xanthine oxidase inhibitor, reduces the production of uric acid, while lesinurad, a uricosuric agent, increases the excretion of uric acid. Clinical trials, including the CLEAR 1 and CLEAR 2 studies, demonstrated that nearly twice as many patients achieved target serum uric acid levels with DUZALLO compared to those taking allopurinol alone[1][4].

FDA Approval and Commercial Availability

DUZALLO received FDA approval in August 2017 and was expected to be commercially available in the fourth quarter of the same year. The approval was based on the clinical program supporting the ZURAMPIC (lesinurad) new drug application and a pharmacokinetic study that evaluated the bioequivalence of the fixed-dose combination[1][4].

Financial Projections and Market Impact

Ironwood Pharmaceuticals anticipated that DUZALLO would be a critical driver of its gout franchise, with projected peak U.S. sales exceeding $300 million annually. This projection was based on the significant unmet need in the gout treatment market and the drug's unique dual-action mechanism[1][4].

Revenue Potential

The financial trajectory of DUZALLO is closely tied to its market performance. Given its unique position as a fixed-dose combination treatment, DUZALLO is expected to capture a substantial share of the gout treatment market. The drug's ability to nearly double the number of patients achieving target serum uric acid levels compared to allopurinol alone is a key factor in its revenue potential[1].

Competitive Landscape

The gout treatment market is competitive, with various treatments available, including xanthine oxidase inhibitors like allopurinol and uricosuric agents like lesinurad. However, DUZALLO's fixed-dose combination offers a unique advantage, making it a preferred option for patients and healthcare providers seeking a more effective and convenient treatment[1][4].

Black Box Warning and Safety Considerations

DUZALLO carries a black box warning for the risk of acute renal failure associated with the use of lesinurad. This safety consideration is crucial and may influence prescribing decisions, although the overall efficacy and safety profile of DUZALLO have been demonstrated in clinical trials[4].

Strategic Partnerships and Licensing Agreements

Ironwood Pharmaceuticals acquired the U.S. rights to lesinurad (ZURAMPIC) from AstraZeneca in a deal that included an upfront payment of $100 million and potential additional sales milestones up to $265 million. This partnership underscores the strategic importance of DUZALLO in Ironwood's portfolio and its commitment to expanding its gout franchise[4].

Market Performance and Sales Growth

While specific sales figures for DUZALLO post-launch are not detailed in the provided sources, the drug's market performance is expected to be robust given its unique positioning and the significant unmet need it addresses. The success of DUZALLO is likely to contribute substantially to Ironwood Pharmaceuticals' revenue growth and reinforce its position in the gout treatment market.

Conclusion

DUZALLO represents a significant advancement in the treatment of hyperuricemia associated with gout, offering a dual-mechanism approach that addresses both the overproduction and underexcretion of serum uric acid. With its FDA approval, commercial availability, and strong clinical efficacy, DUZALLO is poised to make a substantial impact on the market and contribute significantly to Ironwood Pharmaceuticals' financial trajectory.

Key Takeaways

• Unique Mechanism: DUZALLO combines lesinurad and allopurinol, addressing both causes of hyperuricemia.
• Market Need: Targets patients with uncontrolled gout, a population of approximately two million in the U.S.
• Clinical Efficacy: Nearly doubles the number of patients achieving target serum uric acid levels compared to allopurinol alone.
• Financial Projections: Expected to generate over $300 million in peak U.S. sales annually.
• Safety Considerations: Carries a black box warning for the risk of acute renal failure.
• Strategic Partnerships: Acquired U.S. rights to lesinurad from AstraZeneca with significant upfront and milestone payments.

FAQs

What is DUZALLO and how does it work?

DUZALLO is a fixed-dose combination drug that combines lesinurad and allopurinol to treat hyperuricemia associated with gout. It addresses both the overproduction and underexcretion of serum uric acid.

Who is the target population for DUZALLO?

The target population for DUZALLO includes patients with gout whose serum uric acid levels are not adequately controlled with allopurinol or other xanthine oxidase inhibitors alone.

What are the clinical benefits of DUZALLO?

DUZALLO has been shown to nearly double the number of patients achieving target serum uric acid levels compared to those taking allopurinol alone, based on clinical trials like CLEAR 1 and CLEAR 2.

What is the financial projection for DUZALLO?

Ironwood Pharmaceuticals expects DUZALLO to generate over $300 million in peak U.S. sales annually, making it a critical driver of its gout franchise.

Does DUZALLO have any safety warnings?

Yes, DUZALLO carries a black box warning for the risk of acute renal failure associated with the use of lesinurad.

How did Ironwood Pharmaceuticals acquire the rights to lesinurad?

Ironwood Pharmaceuticals acquired the U.S. rights to lesinurad from AstraZeneca in a deal that included an upfront payment of $100 million and potential additional sales milestones up to $265 million.

Sources

1. Ironwood Pharmaceuticals Announces FDA Approval of DUZALLO (lesinurad and allopurinol) for the Treatment of Hyperuricemia in Patients with Uncontrolled Gout. Ironwood Pharmaceuticals. August 21, 2017.
2. AstraZeneca's 2018 annual report. AstraZeneca. February 14, 2019.
3. AstraZeneca Strategic Report 2018. AstraZeneca. February 14, 2019.
4. Ironwood wins FDA approval for combo gout drug. BioPharma Dive. August 21, 2017.