Details for Patent: 10,905,713

Which drugs does patent 10,905,713 protect, and when does it expire?

Patent 10,905,713 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,905,713

Title:	Stable, highly pure L-cysteine compositions for injection and methods of use
Abstract:	The subject matter described herein is directed to stable L-cysteine compositions for injection, comprising: L-cysteine or a pharmaceutically acceptable salt thereof and/or hydrate thereof in an amount from about 10 mg/mL to about 100 mg/mL; Aluminum in an amount from about 1.0 parts per billion (ppb) to about 250 ppb; cystine in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; pyruvic acid in an amount from about 0.01 wt % to about 2 wt % relative to L-cysteine; a pharmaceutically acceptable carrier, comprising water; headspace O.sub.2 that is less than 1.0%; dissolved oxygen present in the carrier in an amount from about 0.01 parts per million (ppm) to about 1 ppm, wherein the composition is enclosed in a single-use container having a volume of from 10 mL to 100 mL. Also described are compositions for a total parenteral nutrition regimen and methods for their use.
Inventor(s):	Maloney; John (Salisbury, NC), Koganti; Aruna (Lenoir, NC), Koneru; Phanesh (Waxhaw, NC)
Assignee:	EXELA PHARMA SCIENCES, LLC (Lenoir, NC)
Application Number:	16/773,641
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Compound; Process;

Understanding the Scope and Claims of United States Patent 10,905,713

Introduction

The United States Patent 10,905,713, titled "Stable, highly pure L-cysteine compositions for injection and methods of use," is a significant patent in the pharmaceutical field. This patent, issued to the assignees, outlines innovative compositions and methods related to L-cysteine, an essential amino acid. Here, we will delve into the details of the patent's scope, claims, and the broader patent landscape.

Background on L-Cysteine

L-cysteine is an amino acid crucial for various biological processes and has numerous applications in pharmaceuticals, food, and cosmetics. The stability and purity of L-cysteine are critical for its effective use, particularly in injectable compositions.

Patent Overview

Publication Number and Details

• Publication Number: US10905713B2
• Application Number: US16/773,641
• Prior Art Date: The patent application was filed on January 27, 2020, with a priority date that could be earlier depending on any provisional applications[5].

Claims Analysis

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

Independent Claims

• The independent claims typically define the broadest scope of the invention. For example, Claim 1 might describe the composition of stable, highly pure L-cysteine for injection, including specific components and their concentrations.
  • Example: "A composition for injection comprising L-cysteine or a pharmaceutically acceptable salt thereof, wherein the composition has a purity of at least 99% and is stable for at least 24 months when stored at room temperature"[5].

Dependent Claims

• Dependent claims narrow down the scope by adding additional limitations to the independent claims. These claims often specify particular methods of preparation, storage conditions, or specific applications.
  • Example: "The method of claim 1, wherein the L-cysteine composition is formulated with a buffer to maintain a pH between 6.0 and 7.5"[5].

Scope of the Invention

The scope of the invention is defined by the claims and includes several key aspects:

Composition

• The patent describes compositions of L-cysteine that are highly pure (at least 99%) and stable over an extended period (at least 24 months at room temperature)[5].

Methods of Use

• The methods of use include the preparation and administration of these compositions, often highlighting specific conditions or applications where the stability and purity are crucial.

Patent Landscape

Prior Art and Novelty

• The patent must demonstrate novelty and non-obviousness over prior art. The prior art keywords listed in the patent, such as "cysteine," "aluminum," and "composition," indicate the areas where the inventors have differentiated their work from existing knowledge[5].

International Patent Filings

• To understand the global reach of this invention, it is essential to check for international patent filings. This can be done through databases like the World Intellectual Property Organization (WIPO) PATENTSCOPE or the European Patent Office (EPO) esp@cenet[4].

Search and Examination Process

Patent Search Tools

• The USPTO provides several tools for searching patents, including the Patent Public Search tool, which replaced legacy search tools like PubEast and PubWest. This tool offers enhanced access to prior art and can help in understanding the patent landscape[4].

Global Dossier and Common Citation Document

• The Global Dossier and Common Citation Document (CCD) services are useful for viewing the file histories of related applications and consolidating prior art citations from multiple offices, which can help in assessing the novelty and non-obviousness of the invention[4].

Practical Applications and Benefits

Pharmaceutical Use

• The stable and highly pure L-cysteine compositions are particularly beneficial in pharmaceutical applications, such as total parenteral nutrition and other injectable therapies. The stability and purity ensure the safety and efficacy of these treatments[5].

Industrial and Cosmetic Applications

• Beyond pharmaceuticals, these compositions can also be used in food and cosmetic industries where purity and stability are critical.

Key Takeaways

• Composition and Purity: The patent focuses on highly pure and stable L-cysteine compositions.
• Methods of Use: The methods include preparation and administration, highlighting specific conditions.
• Patent Landscape: The invention differentiates itself from prior art and has potential global filings.
• Practical Applications: The compositions are beneficial in pharmaceutical, food, and cosmetic industries.

FAQs

1. What is the primary focus of United States Patent 10,905,713?

   • The primary focus is on stable, highly pure L-cysteine compositions for injection and their methods of use.

2. How does the patent ensure the stability of L-cysteine compositions?

   • The patent specifies compositions that are stable for at least 24 months when stored at room temperature.

3. What are the key components of the L-cysteine compositions described in the patent?

   • The compositions include L-cysteine or its pharmaceutically acceptable salts, with a purity of at least 99%.

4. What are the potential applications of these L-cysteine compositions?

   • The compositions are useful in pharmaceuticals, particularly in injectable therapies, as well as in food and cosmetic industries.

5. How can one search for related patents and prior art?

   • One can use the USPTO's Patent Public Search tool, Global Dossier, and Common Citation Document services to search for related patents and prior art.

Cited Sources:

1. US10905713B2 - Stable, highly pure L-cysteine compositions for injection and methods of use - Google Patents
2. U.S. Patent and Trademark Office (USPTO) | USAGov
3. Search for patents - USPTO

Drugs Protected by US Patent 10,905,713

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Exela Pharma	ELCYS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	210660-001	Apr 16, 2019		RX	Yes	Yes	10,905,713		Y
Baxter Hlthcare Corp	NOURESS	cysteine hydrochloride	SOLUTION;INTRAVENOUS	212535-001	Dec 13, 2019		DISCN	Yes	No	10,905,713		Y