Details for Patent: 9,156,795

Which drugs does patent 9,156,795 protect, and when does it expire?

Patent 9,156,795 protects KOSELUGO and is included in one NDA.

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

Summary for Patent: 9,156,795

Title:	Hydrogen sulfate salt
Abstract:	The present invention relates to Compound 1 hydrogen sulfate salt and solvates, crystalline forms and amorphous forms thereof, and to processes for their preparation. ##STR00001##
Inventor(s):	DeMattei; John (San Diego, CA), Chuang; Tsung-Hsun (Longmont, CO), Squire; Christopher John (Macclesfield, GB), Roberts; Ronald John (Macclesfield, GB), Sharma-Singh; Gorkhn (Macclesfield, GB), Pervez; Mohammed (Macclesfield, GB), Ford; James Gair (Macclesfield, GB), Storey; Richard Anthony (Macclesfield, GB), Dickinson; Paul Alfred (Macclesfield, GB)
Assignee:	Array BioPharma, Inc. (Boulder, CO) Astrazeneca AB (Sodertalje, SE)
Application Number:	13/463,499
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Understanding the Scope and Claims of United States Patent 9,156,795

Introduction

United States Patent 9,156,795, issued on October 13, 2015, is a significant patent in the pharmaceutical sector, particularly in the field of cancer treatment. This patent is associated with a novel salt form of a MEK inhibitor, which is crucial for treating proliferative disease states such as cancer.

Patent Overview

The patent, titled "Hydrogen sulfate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide," focuses on a specific compound known as Compound 1. This compound is a MEK (mitogen-activated protein kinase kinase) inhibitor, which plays a vital role in the treatment and prophylaxis of cancer and other proliferative diseases[1][2].

Scope of the Patent

The scope of this patent is broad and encompasses several key aspects:

Compound 1 and Its Derivatives

• The patent covers the hydrogen sulfate salt of Compound 1, including its solvates, crystalline forms, and amorphous forms. This includes various physical forms of the compound, which are important for pharmaceutical formulation and stability[1][2].

Preparation Processes

• The patent details processes for the preparation of the hydrogen sulfate salt of Compound 1. This includes methods for synthesizing the compound, purifying it, and forming different physical forms such as crystalline and amorphous forms[1].

Therapeutic Applications

• The patent highlights the therapeutic use of the hydrogen sulfate salt of Compound 1 in treating proliferative disease states, particularly cancer. It outlines the use of this compound in the manufacture of medicaments for human or animal treatment[1].

Claims of the Patent

The claims of the patent are detailed and specific, ensuring broad protection for the inventors and the assignee:

Independent Claims

• The patent includes independent claims that define the novel salt form of Compound 1, its solvates, and its various physical forms. These claims are crucial for establishing the novelty and non-obviousness of the invention[1].

Dependent Claims

• Dependent claims further specify the scope by detailing particular aspects of the compound, such as its crystalline forms, amorphous forms, and solvates. These claims provide additional protection by covering various embodiments of the invention[1].

Patent Landscape

The patent landscape surrounding US 9,156,795 is complex and involves several related patents and exclusivity periods:

Related Patents

• Other patents related to MEK inhibitors, such as Patent 8,178,693 and Patent 7,425,637, also cover aspects of Compound 1 and its derivatives. These patents expire on different dates, with some expiring as early as March 13, 2025[2].

Patent Expiration Dates

• The patent US 9,156,795 itself is set to expire on December 12, 2026. This expiration date is critical for understanding when generic versions of the drug could potentially enter the market[2].

Exclusivity Periods

• In addition to patent protection, the drug may also have exclusivity periods granted by the FDA. These periods can run concurrently with or independently of the patent terms, affecting the market entry of generic drugs[2].

Impact on Pharmaceutical Industry

The patent has significant implications for the pharmaceutical industry:

Innovation and Competition

• The patent encourages innovation by protecting the intellectual property of the inventors, allowing them to recoup their investment in research and development. However, it also limits competition by preventing other companies from manufacturing the same drug until the patent expires[3].

Generic Entry

• The expiration of this patent in 2026 will open the door for generic manufacturers to develop and market their own versions of the drug, potentially reducing costs and increasing accessibility for patients[2].

Conclusion and Key Takeaways

• Compound and Derivatives: The patent covers the hydrogen sulfate salt of Compound 1, including its solvates, crystalline forms, and amorphous forms.
• Preparation Processes: Detailed methods for synthesizing and purifying the compound are included.
• Therapeutic Applications: The compound is used in treating proliferative disease states, particularly cancer.
• Claims: Independent and dependent claims define the scope of the patent.
• Patent Landscape: Related patents and exclusivity periods are crucial for understanding the market dynamics.
• Impact: The patent affects innovation, competition, and the potential entry of generic drugs.

FAQs

1. What is the main compound covered by US Patent 9,156,795?

   • The main compound is the hydrogen sulfate salt of 6-(4-bromo-2-chloro-phenylamino)-7-fluoro-3-methyl-3H-benzoimidazole-5-carboxylic acid (2-hydroxy-ethoxy)-amide, known as Compound 1[1].

2. What are the therapeutic applications of Compound 1?

   • Compound 1 is used in the treatment and prophylaxis of proliferative disease states, such as cancer[1].

3. When does the patent US 9,156,795 expire?

   • The patent is set to expire on December 12, 2026[2].

4. What is the significance of solvates and crystalline forms in this patent?

   • Solvates and crystalline forms are important for the stability and formulation of the drug, ensuring its efficacy and shelf life[1].

5. How does this patent impact the pharmaceutical industry?

   • It protects the intellectual property of the inventors, encourages innovation, but also limits competition until the patent expires, after which generic versions can enter the market[2][3].

Sources

1. US9156795B2 - Hydrogen sulfate salt - Google Patents
2. Generic Koselugo Availability - Drugs.com
3. Patent Claims and Patent Scope - Hoover Institution

Drugs Protected by US Patent 9,156,795

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-001	Apr 10, 2020		RX	Yes	No	9,156,795		Y	Y
Astrazeneca	KOSELUGO	selumetinib sulfate	CAPSULE;ORAL	213756-002	Apr 10, 2020		RX	Yes	Yes	9,156,795		Y	Y

International Family Members for US Patent 9,156,795

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1968948		301139	Netherlands
European Patent Office	1968948		LUC00234	Luxembourg
European Patent Office	1968948		CA 2021 00044	Denmark
European Patent Office	1968948		PA2021530	Lithuania
European Patent Office	1968948		2021C/549	Belgium