Details for Patent: 8,084,483

Which drugs does patent 8,084,483 protect, and when does it expire?

Patent 8,084,483 protects DUZALLO and ZURAMPIC and is included in two NDAs.

This patent has ninety-one patent family members in thirty-seven countries.

Summary for Patent: 8,084,483

Title:	Compounds and compositions and methods of use
Abstract:	Described herein are compounds useful in the modulation of blood uric acid levels, formulations containing them and methods of using them. In some embodiments, the compounds described herein are used in the treatment or prevention of disorders related to aberrant levels of uric acid.
Inventor(s):	Quart; Barry D. (Encinitas, CA), Girardet; Jean-Luc (San Diego, CA), Gunic; Esmir (San Diego, CA), Yeh; Li-Tain (Irvine, CA)
Assignee:	Ardea Biosciences, Inc. (San Diego, CA)
Application Number:	12/324,764
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 8,084,483

Introduction

United States Patent 8,084,483, along with several other related patents, is a crucial component of the intellectual property portfolio for ZURAMPIC (lesinurad), a drug developed by Ardea Biosciences, Inc. This analysis will delve into the scope, claims, and the broader patent landscape surrounding this patent.

Background of ZURAMPIC

ZURAMPIC (lesinurad) is a uric acid reabsorption inhibitor used in the treatment of gout. It was approved by the FDA on December 22, 2015, as part of new drug application (NDA) 207988[2][4][5].

Patent Overview

Patent Number and Filing Dates

The patent in question, U.S. Patent No. 8,084,483, is one of several patents associated with ZURAMPIC. It was filed on November 26, 2008, and claims the benefit of priority from earlier provisional patent applications[1][2].

Claims and Scope

The patent claims cover the composition and method of use of lesinurad, specifically its role in inhibiting uric acid reabsorption in the kidneys. The claims are detailed and include various aspects such as the chemical structure of lesinurad, its pharmaceutical formulations, and the methods for its administration and use in treating gout and other hyperuricemia-related conditions[2].

Regulatory Review Period and Patent Term Extension

Regulatory Review Period

The regulatory review period for ZURAMPIC, which includes both the testing and approval phases, was a significant factor in determining the patent term extension. The testing phase began with the effective date of the earliest IND (Investigational New Drug) application, October 31, 2009, and ended with the submission of the NDA on December 29, 2014. The approval phase spanned from the NDA submission to the FDA approval on December 22, 2015. This period totaled 2,245 days[1][4].

Patent Term Extension

Under 35 U.S.C. § 156, the patent term can be extended to compensate for the time spent in regulatory review. For U.S. Patent No. 8,084,483, the extension was calculated based on the regulatory review period, minus certain deductions for periods before patent issuance and lack of due diligence. The maximum extension possible was subject to statutory limitations, including a maximum of five years and a cap of 14 years after the date of FDA approval[1][4].

Statutory Limitations and Calculations

Maximum Extension

The calculated extension period was subject to a maximum of five years under 35 U.S.C. §156(g)(6)(A), and it could not exceed 14 years after the FDA approval date under 35 U.S.C. §156(c)(3). For U.S. Patent No. 8,084,483, the extension did not exceed these limits, resulting in an extended patent term[1][4].

Due Diligence

The FDA verified that no petitions were filed challenging the applicant's due diligence during the regulatory review period. This ensured that the full calculated extension could be applied without further reductions[2][4].

Patent Landscape

Related Patents

U.S. Patent No. 8,084,483 is part of a suite of patents that cover various aspects of ZURAMPIC, including U.S. Patent Nos. 8,003,681, 8,283,369, 8,357,713, and 8,546,437. These patents collectively protect the drug's composition, method of use, and other related intellectual property[2][4][5].

Industry Impact

The patents surrounding ZURAMPIC are critical for Ardea Biosciences, Inc., and its successors in maintaining market exclusivity for the drug. This exclusivity is essential for recouping the significant investments made in research, development, and regulatory approvals.

Key Takeaways

• Patent Scope: U.S. Patent No. 8,084,483 covers the composition and method of use of lesinurad, a uric acid reabsorption inhibitor.
• Regulatory Review: The patent term extension was based on a regulatory review period of 2,245 days.
• Statutory Limitations: The extension was subject to maximum limits of five years and 14 years after FDA approval.
• Due Diligence: No petitions were filed challenging the applicant's due diligence.
• Patent Landscape: The patent is part of a suite of patents protecting ZURAMPIC, ensuring market exclusivity.

FAQs

What is the primary use of ZURAMPIC (lesinurad)?

ZURAMPIC (lesinurad) is used in the treatment of gout by inhibiting uric acid reabsorption in the kidneys.

When was ZURAMPIC approved by the FDA?

ZURAMPIC was approved by the FDA on December 22, 2015.

What is the significance of the regulatory review period in patent term extension?

The regulatory review period determines the maximum potential length of a patent extension under 35 U.S.C. § 156.

How is the patent term extension calculated?

The extension is calculated by subtracting certain periods from the total regulatory review period, including periods before patent issuance and lack of due diligence.

What are the statutory limitations on patent term extensions?

The extension cannot exceed five years or 14 years after the FDA approval date.

Sources

1. Regulations.gov: FEB 16 2016 - Regulations.gov
2. FDA U.S. FOOD & DRUG: FDA U.S. FOOD & DRUG OCT 1 0 MR Re: ZURAMPIC Patent Nos ...
3. USPTO: Patent Claims Research Dataset - USPTO
4. Federal Register: 4164-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES ...
5. Regulations.gov: (···~ II u.s. FOOD & DRUG - Regulations.gov

Drugs Protected by US Patent 8,084,483

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-001	Aug 18, 2017		DISCN	Yes	No						TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No						TREATMENT OF HYPERURICEMIA ASSOCIATED WITH GOUT IN PATIENTS WHO HAVE NOT ACHIEVED TARGET SERUM URIC ACID LEVELS WITH A MEDICALLY APPROPRIATE DAILY DOSE OF ALLOPURINOL ALONE
Ironwood Pharms Inc	ZURAMPIC	lesinurad	TABLET;ORAL	207988-001	Dec 22, 2015		DISCN	Yes	No						REDUCTION OF SERUM URIC ACID LEVELS

International Family Members for US Patent 8,084,483

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2217577		2016016	Norway
European Patent Office	2217577		CA 2019 00003	Denmark
European Patent Office	2217577		PA2019003	Lithuania
European Patent Office	2217577		300970	Netherlands
European Patent Office	2217577		2019C/502	Belgium
European Patent Office	2217577		122019000008	Germany