ZURAMPIC Drug Patent Profile

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

Zurampic 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 ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurampic

Zurampic was eligible for patent challenges on December 22, 2019.

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 ZURAMPIC

International Patents:	200
US Patents:	9
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Patent Applications:	188
Drug Prices:	Drug price information for ZURAMPIC
DailyMed Link:	ZURAMPIC at DailyMed

See drug prices for ZURAMPIC

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

NDA:

207988

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 ZURAMPIC

ZURAMPIC is protected by twelve US patents.

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	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No				Y
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No

EU/EMA Drug Approvals for ZURAMPIC

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Grünenthal GmbH	Zurampic	lesinurad	EMEA/H/C/003932 Zurampic, in combination with a xanthine oxidase inhibitor, is indicated in adults for the adjunctive treatment of hyperuricaemia in gout patients (with or without tophi) who have not achieved target serum uric acid levels with an adequate dose of a xanthine oxidase inhibitor alone.,	Withdrawn	no	no	no	2016-02-18

International Patents for ZURAMPIC

When does loss-of-exclusivity occur for ZURAMPIC?

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 ZURAMPIC 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 ZURAMPIC

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

ZURAMPIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Zurampic

Introduction to Zurampic

Zurampic, also known as lesinurad, is a medication developed for the treatment of hyperuricemia (excess uric acid in the blood) in adult patients with uncontrolled gout. Here, we will delve into the market dynamics and financial trajectory of this drug.

Development and Approval

Zurampic was approved by the FDA in 2015 and by the European Medicines Agency (EMA) in 2016, in combination with a xanthine oxidase inhibitor (XOI), for the adjunctive treatment of hyperuricemia in adult patients with uncontrolled gout[1][4].

Initial Market Expectations

When Zurampic was first approved, analysts had high hopes for its market performance, predicting peak sales of $500 million or more. However, the drug faced several challenges from the outset, including missing primary endpoints in all three of its late-stage trials and carrying a black-box warning for kidney failure[1].

Licensing and Partnership Dynamics

AstraZeneca initially acquired the rights to Zurampic as part of its $1.3 billion acquisition of Ardea Biosciences in 2012. In 2016, AstraZeneca licensed the exclusive rights to Zurampic in Europe and Latin America to Grünenthal GmbH. This agreement included the fixed-dose combination of lesinurad and allopurinol and involved significant milestone and royalty payments[4].

Ironwood Pharmaceuticals' Involvement

In 2016, Ironwood Pharmaceuticals entered into a licensing agreement with AstraZeneca to market Zurampic in the U.S. Ironwood paid $100 million upfront and committed to up to $165 million in milestones and royalties. However, after conducting market tests, Ironwood decided to terminate the agreement in 2018, citing that the data did not meet expectations. This decision led to the layoff of 125 employees and saved Ironwood between $75 million and $100 million in expenses for 2019[1].

Financial Impact on AstraZeneca

The termination of the licensing agreement by Ironwood Pharmaceuticals left AstraZeneca to reassess its strategy for Zurampic. The drug had been a significant investment for AstraZeneca, but its performance did not meet the anticipated levels. The financial burden of this drug, combined with the costs associated with its development and marketing, contributed to AstraZeneca's decision to focus on other strategic priorities[1].

Grünenthal GmbH's Role

Grünenthal GmbH, which acquired the exclusive rights to Zurampic in Europe and Latin America, committed to submitting the fixed-dose combination for regulatory review and paying up to $230 million in sales and other related milestones. Grünenthal also agreed to pay tiered, low double-digit royalties on annual product sales. This partnership allowed AstraZeneca to focus on its core business while leveraging Grünenthal's expertise in inflammatory diseases and chronic pain[4].

Market Performance and Challenges

Despite the initial optimism, Zurampic faced significant market challenges. The drug's safety profile, including the risk of kidney failure, and its failure to meet primary endpoints in clinical trials, contributed to its underperformance. These factors, combined with the competitive landscape in the gout treatment market, made it difficult for Zurampic to achieve the predicted sales figures[1].

Current Market Status

As of the latest updates, Zurampic's market presence is largely managed by Grünenthal GmbH in Europe and Latin America. The drug continues to be available for patients, but its overall market impact has been muted compared to initial expectations. AstraZeneca has shifted its focus to other products and therapeutic areas, reflecting the dynamic nature of the pharmaceutical market where companies continually reassess and adjust their portfolios based on performance and market conditions[4].

Key Takeaways

• Challenging Market Entry: Despite FDA and EMA approvals, Zurampic faced significant challenges, including safety concerns and missed clinical trial endpoints.
• Licensing and Partnerships: The drug was licensed to various companies, including Ironwood Pharmaceuticals and Grünenthal GmbH, reflecting the complex nature of pharmaceutical partnerships.
• Financial Implications: The underperformance of Zurampic led to significant financial adjustments for AstraZeneca and Ironwood Pharmaceuticals.
• Market Dynamics: The competitive gout treatment market and safety concerns hindered Zurampic's ability to achieve predicted sales figures.

FAQs

Q: What is Zurampic used for?

A: Zurampic (lesinurad) is used for the adjunctive treatment of hyperuricemia (excess uric acid in the blood) in adult patients with uncontrolled gout.

Q: Who initially developed and approved Zurampic?

A: AstraZeneca developed Zurampic, and it was approved by the FDA in 2015 and by the EMA in 2016.

Q: Why did Ironwood Pharmaceuticals terminate its licensing agreement for Zurampic?

A: Ironwood Pharmaceuticals terminated the agreement due to market test data that did not meet expectations.

Q: What are the safety concerns associated with Zurampic?

A: Zurampic carries a black-box warning for kidney failure and has other safety concerns that have impacted its market performance.

Q: Who currently holds the exclusive rights to market Zurampic in Europe and Latin America?

A: Grünenthal GmbH holds the exclusive rights to market Zurampic in these regions.

Cited Sources

1. FiercePharma: "Ironwood dumps AstraZeneca gout drug Zurampic—and lays off 125 in process"[1]
2. StockTitan: "Zura Bio Reports Third Quarter 2024 Financial Results and Recent Corporate Updates"[2]
3. Ironwood Pharmaceuticals: "UNITED STATES SECURITIES AND EXCHANGE COMMISSION"[3]
4. AstraZeneca: "AstraZeneca licenses Zurampic to Grünenthal GmbH in Europe and Latin America"[4]