Lesinurad - Generic Drug Details

What are the generic sources for lesinurad and what is the scope of patent protection?

Lesinurad is the generic ingredient in one branded drug marketed by Ironwood Pharms Inc and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lesinurad has two hundred patent family members in forty-two countries.

Summary for lesinurad

International Patents:	200
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	19
Patent Applications:	333
DailyMed Link:	lesinurad at DailyMed

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

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.

Recent Clinical Trials for lesinurad

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ironwood Pharmaceuticals, Inc.	Phase 4
Medpace, Inc.	Phase 4
Ardea Biosciences, Inc.	Phase 1

See all lesinurad clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for lesinurad

M04AB	Preparations increasing uric acid excretion
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

US Patents and Regulatory Information for lesinurad

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
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			Y

EU/EMA Drug Approvals for lesinurad

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 lesinurad

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
Denmark	2135608

Supplementary Protection Certificates for lesinurad

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
2217577	2016016	Norway		PRODUCT NAME: LESINURAD, ELLER ET; REG. NO/DATE: EU/1/15/1080 20160303

Lesinurad Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lesinurad

Introduction to Lesinurad

Lesinurad, marketed under the brand name ZURAMPIC, is a novel drug designed to treat hyperuricemia associated with gout. It works by inhibiting the urate transporter URAT1, thereby increasing the excretion of uric acid and lowering serum uric acid (sUA) levels when used in combination with xanthine oxidase inhibitors (XOIs) like allopurinol or febuxostat[4].

FDA Approval and Market Entry

Lesinurad was approved by the US FDA in December 2015 for use in patients who had not achieved target sUA levels with an XOI alone. This approval marked a significant milestone, offering a new treatment option for patients with inadequately controlled gout[4].

Clinical Efficacy and Safety

Clinical trials, such as the CLEAR 2 study, have demonstrated the efficacy and safety of lesinurad when combined with allopurinol. The study showed that lesinurad at 200 and 400 mg doses significantly increased the proportion of patients achieving target sUA levels compared to allopurinol alone. The 200 mg dose was particularly well-tolerated, with a safety profile comparable to allopurinol-alone therapy[1].

Market Need and Target Population

Gout is a chronic condition affecting millions worldwide, with more than 50% of patients not achieving sustained reductions in sUA levels with standard allopurinol therapy. Lesinurad addresses this unmet need by providing a dual mechanism of action to lower sUA levels, making it a valuable addition to the treatment arsenal for gout[1][4].

Commercial Performance and Revenue

Initially, lesinurad was licensed to Ironwood Pharmaceuticals for the U.S. market. However, Ironwood terminated this licensing agreement in 2018, citing the need to allocate capital to higher return opportunities. Despite this, lesinurad remained available for patients during the transition period[3].

The commercial performance of lesinurad has been influenced by several factors, including market competition, pricing strategies, and the overall demand for gout treatments. While specific revenue figures for lesinurad are not detailed in the available sources, its approval and integration into treatment guidelines have contributed to its market presence.

Financial Trajectory

Initial Projections and Forecasts

AstraZeneca, the original developer of lesinurad, had included it in their long-range plans and forecasts. However, the financial trajectory of lesinurad has been subject to various factors, including the termination of the licensing agreement with Ironwood Pharmaceuticals and the competitive landscape of gout treatments[2][3].

Impact of Licensing Agreement Termination

The termination of the licensing agreement with Ironwood Pharmaceuticals in 2018 had significant financial implications. Ironwood had to adjust its financial guidance and restructuring costs, which affected their overall financial performance for that year. This move also reflected the company's strategy to focus on higher return opportunities[3].

Current Market Position

Despite the challenges, lesinurad remains a valuable treatment option for gout patients. Its unique mechanism of action and clinical efficacy have established it as a part of the treatment paradigm for hyperuricemia associated with gout. The financial trajectory, while influenced by licensing and market dynamics, continues to be shaped by its clinical utility and market demand.

Competitive Landscape

The gout treatment market is competitive, with several XOIs and other urate-lowering therapies available. Lesinurad's differentiation lies in its ability to increase uric acid excretion when combined with XOIs, offering a dual mechanism of action that enhances treatment outcomes. This competitive advantage helps lesinurad maintain its market position despite the presence of other treatments[1][4].

Regulatory and Clinical Milestones

Lesinurad's approval by the FDA marked a significant regulatory milestone. Clinical trials, such as the CLEAR 2 study, have provided robust data supporting its efficacy and safety. These milestones are crucial for maintaining regulatory approvals and guiding clinical practice[1][4].

Patient and Physician Adoption

The adoption of lesinurad by patients and physicians is influenced by its clinical efficacy, safety profile, and ease of use. Positive outcomes from clinical trials and real-world evidence have contributed to its acceptance as a treatment option for patients with inadequately controlled gout.

Future Outlook

The future outlook for lesinurad is tied to its continued clinical utility and market demand. As gout remains a prevalent condition with significant unmet needs, lesinurad is likely to remain a relevant treatment option. Ongoing research and real-world studies will continue to shape its market dynamics and financial trajectory.

Key Takeaways

• Lesinurad is approved for treating hyperuricemia associated with gout in combination with XOIs.
• It offers a dual mechanism of action, enhancing uric acid excretion and reducing production.
• Clinical trials have demonstrated its efficacy and safety.
• The drug's market dynamics have been influenced by licensing agreements and competitive market factors.
• Despite challenges, lesinurad remains a valuable treatment option for gout patients.

Frequently Asked Questions (FAQs)

What is lesinurad used for?

Lesinurad is used to treat hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with xanthine oxidase inhibitors (XOIs) alone.

How does lesinurad work?

Lesinurad inhibits the urate transporter URAT1, increasing the excretion of uric acid and lowering serum uric acid levels when used in combination with XOIs.

What are the common side effects of lesinurad?

Common side effects include renal-related adverse events, such as serum creatinine elevation, and other treatment-emergent adverse events. However, the 200 mg dose has a safety profile comparable to allopurinol-alone therapy[1].

Is lesinurad approved by regulatory authorities?

Yes, lesinurad was approved by the US FDA in December 2015 for use in combination with XOIs for the treatment of hyperuricemia associated with gout[4].

What was the impact of the licensing agreement termination on lesinurad's market presence?

The termination of the licensing agreement with Ironwood Pharmaceuticals led to a reevaluation of financial guidance and restructuring costs but did not significantly impact the drug's availability or clinical utility[3].

Cited Sources:

1. Lesinurad Added to Allopurinol in Patients with Gout. Annals of the Rheumatic Diseases, 76(5), 811-819.
2. Delivering Value for Patients and Shareholders. AstraZeneca, May 2014.
3. Ironwood Pharmaceuticals Provides Second Quarter 2018 Investor Update. Ironwood Pharmaceuticals, August 6, 2018.
4. ZURAMPIC (lesinurad) approved by US FDA for patients with gout. AstraZeneca, December 22, 2015.