Details for Patent: 10,493,028

Which drugs does patent 10,493,028 protect, and when does it expire?

Patent 10,493,028 protects FIRVANQ KIT and is included in one NDA.

This patent has nine patent family members in seven countries.

Summary for Patent: 10,493,028

Title:	Composition and method for vancomycin oral liquid
Abstract:	The invention relates to stable vancomycin hydrochloride powder for oral liquid formulations. Also provided herein are methods of using vancomycin oral liquid formulations for the treatment of certain diseases such as Clostridium difficile pseudomembranous colitis and Staphylococcal enterocolitis as well as kits and related products thereof.
Inventor(s):	Indu Muni, Peter Mione, Anisa Gandhi, Cristina LeChiara
Assignee:	Azurity Pharmaceuticals Inc
Application Number:	US15/791,717
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,493,028
Patent Claim Types: see list of patent claims

Detailed Analysis of the Scope and Claims of United States Patent 10,493,028

Introduction

United States Patent 10,493,028, titled "Composition and Method for Vancomycin Oral Liquid," is a significant patent in the pharmaceutical industry, particularly in the development and formulation of vancomycin hydrochloride for oral administration. This patent, assigned to Azurity Pharmaceuticals, Inc., addresses the stability and efficacy of vancomycin oral liquid formulations.

Background and Context

Vancomycin is a potent antibiotic used to treat various bacterial infections, including those caused by Clostridioides difficile. The development of an oral liquid formulation is crucial for patient compliance and effectiveness, especially in pediatric and geriatric populations.

Inventors and Assignee

The patent was invented by Indu Muni, Peter Mione, Anisa Gandhi, and Cristina LeChiara, and is assigned to Azurity Pharmaceuticals, Inc.[2][4].

Patent Scope and Claims

The patent encompasses several key aspects:

Composition

The patent describes a stable vancomycin hydrochloride powder for oral liquid formulations. The composition includes vancomycin hydrochloride, along with various excipients such as sweeteners (e.g., sucralose), tonicity agents, and chelating agents. The formulation is designed to improve the stability and palatability of the oral liquid[1][4].

Method of Preparation

The method involves mixing a powder form of vancomycin hydrochloride with a liquid solution (diluent) to create the compounded oral liquid. The liquid solution can include water and other ingredients that enhance the stability and taste of the final product[4].

Stability

The patent highlights the stability of the vancomycin hydrochloride in the formulated oral liquid. The stability data show that the formulation remains effective under various storage conditions, ensuring the potency of the antibiotic over its shelf life[4].

Claims

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

Independent Claims

• Claim 1 typically describes the composition of the vancomycin hydrochloride powder and the method of preparing the oral liquid formulation.
• Subsequent claims detail specific concentrations of ingredients, such as anhydrous citric acid, sucralose, and other excipients[4].

Dependent Claims

• These claims further specify the characteristics of the composition, such as the pH range, tonicity, and the presence of additional ingredients like flavoring agents and preservatives[4].

Patent Landscape

The patent landscape surrounding US 10,493,028 is complex and involves several related patents and legal actions:

Related Patents

• The patent is part of a series of related patents, including US 10,688,046, US 10,959,946, US 10,959,947, US 10,959,948, and US 10,959,949, all of which pertain to similar compositions and methods for vancomycin oral liquids[2][4].
• These patents collectively cover various aspects of the formulation, including different excipients and stability enhancements.

Litigation

• Azurity Pharmaceuticals, Inc. has been involved in several patent infringement lawsuits related to these patents. For example, the company has sued Annora Pharma Private Ltd. and Alkem Labs., Ltd. for allegedly infringing on these patents[2][5].

Impact on the Pharmaceutical Industry

The patent has significant implications for the pharmaceutical industry:

Patient Compliance

• The development of a stable and palatable oral liquid formulation of vancomycin enhances patient compliance, particularly in populations that have difficulty with traditional solid dosage forms[1].

Market Competition

• The patent and related litigation shape the competitive landscape in the market for vancomycin products. Companies must navigate these intellectual property rights to develop and market their own vancomycin formulations[2][5].

Key Takeaways

• Stable Formulation: The patent provides a stable vancomycin hydrochloride powder for oral liquid formulations.
• Method of Preparation: The method involves mixing the powder with a liquid solution to create the compounded oral liquid.
• Excipients: The formulation includes various excipients to enhance stability and palatability.
• Patent Landscape: The patent is part of a series of related patents and has been involved in several litigation cases.
• Industry Impact: The patent affects patient compliance and market competition in the pharmaceutical industry.

FAQs

1. What is the main focus of United States Patent 10,493,028?

   • The main focus is on the composition and method for creating a stable vancomycin hydrochloride oral liquid formulation.

2. Who are the inventors of this patent?

   • The inventors are Indu Muni, Peter Mione, Anisa Gandhi, and Cristina LeChiara.

3. Which company is assigned this patent?

   • The patent is assigned to Azurity Pharmaceuticals, Inc.

4. What are some of the key excipients in the formulation?

   • Key excipients include sucralose, anhydrous citric acid, tonicity agents, and chelating agents.

5. Has this patent been involved in any litigation?

   • Yes, Azurity Pharmaceuticals, Inc. has been involved in several patent infringement lawsuits related to this and related patents.

Citations

1. US10493028B2 - Composition and method for vancomycin oral liquid - Google Patents
2. Complaint for Patent Infringement - Insight.RPXcorp
3. Patent Claims and Patent Scope - SSRN
4. United States Patent - Google APIs
5. Azurity Pharms., Inc. v. Alkem Labs., Ltd. - Robins Kaplan LLP

Drugs Protected by US Patent 10,493,028

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes			Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes			Y

International Family Members for US Patent 10,493,028

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015229069
Canada	2941867
China	106573037
European Patent Office	3145527
European Patent Office	4000628
Spain	2903419
Japan	2017508807