Details for Patent: 10,154,963

Which drugs does patent 10,154,963 protect, and when does it expire?

Patent 10,154,963 protects SOAANZ and is included in one NDA.

This patent has two patent family members in two countries.

Summary for Patent: 10,154,963

Title:	Controlled-release formulations comprising Torsemide
Abstract:	Disclosed herein are controlled-release (GR, e.g., extended-release (ER) or prolonged-release (PR)) oral dosage formulation comprising an effective amount of Torsemide or a pharmaceutically acceptable salt thereof and at least one sustained release excipient comprising a polymer, wherein the at least one matrix component is selected from the group consisting of: hydroxy propyl cellulose (HPC), hydroxpropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. Torsemide may be present in the formulation in a range of about 1 wt % to about 20 wt %, or about 5 wt % to about 10 wt % and the matrix component is present in the formulation in a range of about 5 wt % to about 50 wt %, or about 15 wt % to about 35 wt %. The formulation may further comprise at least one binder, lactose, talc and magnesium stearate. Methods of making and using the controlled-release oral dosage Torsemide formulation are also disclosed. A novel mechanism for Torsemide action in diuresis is further disclosed.
Inventor(s):	Shah; Salim (Vienna, VA)
Assignee:	SARFEZ PHARMACEUTICALS, INC. (Vienna, VA)
Application Number:	15/027,355
Patent Claim Types: see list of patent claims	Use; Formulation; Compound; Delivery; Dosage form;

Detailed Analysis of the Scope and Claims of United States Patent 10,154,963

Introduction

United States Patent 10,154,963, titled "Controlled-release formulations comprising Torsemide," is a significant patent in the pharmaceutical industry, particularly in the treatment of conditions such as heart failure and edema. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent, issued on December 18, 2018, to Salim Shah and assigned to Sarfez Pharmaceuticals, Inc., describes an extended-release oral dosage formulation of Torsemide, a loop diuretic used to treat fluid retention (edema) and swelling that is caused by congestive heart failure, liver disease, or a kidney disorder[4][5].

Scope of the Patent

The patent focuses on the development of a controlled-release formulation that enhances the therapeutic efficacy and patient compliance of Torsemide.

Key Components

• Active Ingredient: The formulation includes a therapeutically effective amount of Torsemide or a pharmaceutically acceptable salt thereof.
• Matrix Components: The formulation incorporates at least one matrix component selected from hydroxypropyl cellulose (HPC), hydroxypropyl methyl cellulose (HPMC), glyceryl behenate, and a polyethylene glycol glyceride. These components are crucial for the controlled-release mechanism[4].

Formulation Details

• Torsemide Concentration: The active ingredient is present in the formulation in a range of about 1 wt% to about 20 wt%, or more specifically, about 5 wt% to about 10 wt%.
• Matrix Component Concentration: The matrix component is present in a range of about 5 wt% to about 50 wt%, or more specifically, about 15 wt% to about 35 wt%[4].

Claims of the Patent

The patent includes several claims that define the scope of the invention:

Independent Claims

• Claim 1 describes the extended-release oral dosage formulation comprising Torsemide and at least one matrix component.
• Claim 2 specifies the types of matrix components used.
• Claim 3 details the weight percentages of Torsemide and the matrix components in the formulation[4].

Dependent Claims

These claims further elaborate on the specific characteristics and variations of the formulation, such as the types of excipients, the method of manufacture (e.g., wet granulation), and the physical form of the dosage (e.g., tablets)[4].

Patent Landscape

Understanding the patent landscape is crucial for assessing the exclusivity and potential market entry points for generic versions.

Patent Exclusivity

• The patent is currently active and is estimated to expire on October 6, 2033, based on the filing date and standard patent term. However, this date can be subject to change due to legal activities such as term extensions or amendments to the claims[2][5].

International Protection

While the patent provides exclusivity within the United States, it is important to note that Soaanz, the drug associated with this patent, is also protected by patents in multiple countries. Analyzing the global patent landscape helps in identifying markets with weaker patent protection, which could be ideal for generic entry[2].

Legal Activities

Recent legal activities on the patent include payments of maintenance fees, changes in power of attorney, and correspondence address changes. These activities are critical in maintaining the patent's validity and exclusivity period[2].

Strategic Implications

For pharmaceutical companies and generic manufacturers, understanding the scope and claims of this patent is essential for several reasons:

Market Entry

• The estimated generic launch date of October 6, 2033, provides a clear timeline for potential generic entrants. However, tracking ongoing legal activities on the patent can offer insights into any potential changes in this timeline[2][5].

Patent Analytics

Using tools like ClaimScape® software, companies can analyze the claim coverage and identify gaps or opportunities in their current patent portfolio. This helps in determining whether a particular scope concept is applicable to a target product or method, thereby guiding future development strategies[3].

Competitive Advantage

The exclusive rights granted by this patent to Sarfez Pharmaceuticals, Inc. provide a significant competitive advantage in the market. Other companies must either wait for the patent to expire or develop alternative formulations that do not infringe on the existing claims[5].

Conclusion

United States Patent 10,154,963 is a critical patent in the pharmaceutical industry, particularly for the treatment of heart failure and edema. The controlled-release formulation of Torsemide described in this patent enhances patient compliance and therapeutic efficacy. Understanding the scope, claims, and the broader patent landscape is essential for both the patent holder and potential generic manufacturers.

Key Takeaways

• Patent Scope: The patent covers an extended-release oral dosage formulation of Torsemide with specific matrix components.
• Claims: The patent includes independent and dependent claims defining the formulation, its components, and their concentrations.
• Exclusivity: The patent is active until October 6, 2033, with potential for changes based on legal activities.
• Global Protection: The drug is protected by patents in multiple countries.
• Strategic Implications: Understanding the patent landscape is crucial for market entry, patent analytics, and maintaining a competitive advantage.

FAQs

1. What is the main subject of United States Patent 10,154,963?

   • The main subject is an extended-release oral dosage formulation of Torsemide.

2. Who is the assignee of this patent?

   • The assignee is Sarfez Pharmaceuticals, Inc.

3. What are the key components of the formulation described in the patent?

   • The key components include Torsemide and at least one matrix component such as HPC, HPMC, glyceryl behenate, or a polyethylene glycol glyceride.

4. When is the estimated generic launch date for Soaanz?

   • The estimated generic launch date is October 6, 2033.

5. How can companies track changes in the patent's exclusivity period?

   • Companies can track recent legal activities on the patent, such as payments of maintenance fees, changes in power of attorney, and other critical events.

Sources

1. United States Patent and Trademark Office. US11007203.pdf.
2. Pharsight. Soaanz patent expiration.
3. SLWIP. Patent Analytics.
4. Google Patents. US10154963B2 - Controlled-release formulations comprising Torsemide.
5. Drugs.com. Generic Soaanz Availability.

Drugs Protected by US Patent 10,154,963

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-001	Jun 14, 2021		DISCN	Yes	No			Y
Sarfe Pharms	SOAANZ	torsemide	TABLET;ORAL	213218-002	Jun 14, 2021		DISCN	Yes	No			Y

Foreign Priority and PCT Information for Patent: 10,154,963

PCT Information
PCT Filed	December 26, 2013	PCT Application Number:	PCT/US2013/077732
PCT Publication Date:	April 09, 2015	PCT Publication Number:	WO2015/050570

International Family Members for US Patent 10,154,963

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	3065718
World Intellectual Property Organization (WIPO)	2015050570