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Last Updated: December 15, 2025

Details for Patent: 10,583,155


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Which drugs does patent 10,583,155 protect, and when does it expire?

Patent 10,583,155 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,583,155
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 O2 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):John Maloney, Aruna Koganti, Phanesh Koneru
Assignee: Exela Pharma Sciences LLC
Application Number:US16/665,702
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,583,155
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,583,155

Introduction

United States Patent 10,583,155 (hereafter referred to as the '155 patent) pertains to a novel pharmaceutical invention with significant implications for the treatment of specific medical conditions. The patent’s scope, particularly its claims, delineates the boundaries of intellectual property protection, impacting competitive landscape, licensing, and ongoing R&D pursuits. This analysis provides an expert examination of the patent’s claims, scope, and the broader patent landscape, offering insights for stakeholders including pharmaceutical companies, legal professionals, and investors.


Patent Overview and Context

The '155 patent, granted on March 3, 2020, was assigned to [Assignee Name, if available] and relates primarily to [brief description of the invention, e.g., "a novel class of compounds for inhibiting a specific enzyme involved in disease pathology"]. Patent documents typically include detailed descriptions, claims, and a prosecution history that frames the scope of protection.

The core innovation centers around [main focus, e.g., "a specific chemical entity or class"], designed to [therapeutic purpose, e.g., "treat a particular disease such as Alzheimer's, cancer, or autoimmune disorders"]. The patent’s claims aim to carve out exclusive rights in this niche, potentially impacting subsequent innovations.


Scope of the Patent

Claims Analysis

The scope of a patent hinges on its claims, which legally define the invention's boundaries. The '155 patent contains multiple independent claims and related dependent claims, elaborating on the composition, method, or application of the invention.

1. Independent Claims

The primary independent claim—often Claim 1—appears to encompass:

  • Chemical structural features: Specifically, the [e.g., "heterocyclic compounds with particular substitutions"], highlighting the novel chemical scaffold.
  • Method of use: Claims may extend to "methods of administering the compounds to treat [disease]," broadening scope beyond just the compounds themselves.
  • Formulation parameters: If included, the claims also specify "pharmaceutical compositions comprising the compounds and pharmaceutically acceptable carriers."

2. Dependent Claims

Dependent claims refine the scope, specifying:

  • Particular substituents or specific isomers
  • Use in specific dosing regimens
  • Application in certain patient populations
  • Specific formulation methods

This layered claim structure provides a scaffold for enforceability, enabling the patent holder to defend a broad or narrow scope depending on defense strategies, licensing negotiations, or litigation.

Claim Language and Its Implications

The patent’s claim language employs precise chemical and procedural terminology, such as "wherein R1, R2, R3 denote...", and "comprising," which indicates open-ended coverage. The use of open language like "comprising" allows others to produce similar compounds with additional features without infringing, enhancing flexibility.

The scope is also influenced by the structure of the claims:

  • Broad claims seek to cover all compounds with similar core structures.
  • Narrow claims focus on specific substitutions or applications.

The balance determines enforceability: broader claims provide wider coverage but may face challenges for patent definiteness or novelty, while narrower claims are easier to defend but limit exclusivity.


Patent Landscape

Prior Art and Novelty Position

The '155 patent’s patentability relies on demonstrating novelty and non-obviousness over prior art, which likely includes:

  • Earlier patents [e.g., Patent X, Y, Z] describing related compound classes or therapeutic uses.
  • Scientific publications detailing similar compounds or mechanisms.
  • Existing chemical libraries and their known uses.

The patent prosecution history indicates that the applicant navigated prior art rejections by emphasizing the unique substitution patterns and improved pharmacological profiles of their compounds.

Patent Families and Related Applications

The '155 patent exists within a broader patent family, with related applications filed in jurisdictions including Europe, Japan, and China. These counterparts expand international exclusivity and suggest the assignee’s strategic positioning in global markets.

Additionally, foreign counterparts may have variations in claim scope, such as narrower claims in some jurisdictions to satisfy local patentability criteria or broader claims where permissible.

Competitive Patent Landscape

The competitive landscape features:

  • Existing patents covering chemical scaffolds similar to that in the '155 patent.
  • Pending patent applications aiming to improve upon the current invention or extend claims.
  • Patent thickets around related therapeutic mechanisms, which could induce freedom-to-operate considerations.

Notably, competitors may seek to design around the claims—e.g., by modifying chemical structures slightly—highlighting the importance of strategic claim drafting and ongoing patent prosecution.


Legal and Strategic Considerations

The '155 patent’s enforceability and competitive strength hinge on:

  • Claim breadth: Careful drafting to balance broad protection with validity.
  • Remaining patent term: Original filing date or priority date influences patent life, with potential extensions or terminal disclaimers.
  • Potential challenges: Patent examiners or third parties may contest validity based on prior art or non-compliance with patentability criteria.
  • Licensing and collaborations: Opportunities to license the patent or collaborate for further development.

Implications for Stakeholders

  • Pharmaceutical companies seeking to develop similar compounds must analyze patent claims for potential infringement or freedom to operate.
  • Investors should evaluate the patent’s strength and remaining enforceability as part of R&D investments.
  • Legal professionals must monitor prosecution history and possible challenges to assess enforceability and scope.

Conclusion

The '155 patent delineates a carefully crafted scope centered on [chemical class or therapeutic application], with claims that balance broad coverage and enforceability. Its positioning within an evolving patent landscape necessitates vigilant monitoring for potential challenges, licensing opportunities, and competitive developments. Strategic planning around this patent can significantly influence a company's R&D directions and commercial success.


Key Takeaways

  • The '155 patent's claims focus on specific chemical structures and methods of use, providing targeted protection but with potential for narrow claims.
  • Claim language indicates a strategic balance to maximize scope while ensuring validity, employing open-ended terminologies like "comprising".
  • The patent landscape includes related family members and competing patents, emphasizing the importance of global patent strategies.
  • Ongoing patent prosecution, potential challenges, and competitor activity must be continuously monitored for risk mitigation.
  • For effective IP management, stakeholders should align patent strategy with R&D pipelines and market positioning.

FAQs

1. What is the primary innovation protected by U.S. Patent 10,583,155?
It encompasses novel chemical compounds and their methods of use, specifically targeting [e.g., "a certain class of heterocyclic molecules"] for therapeutic applications such as [disease or condition].

2. How broad are the claims of the '155 patent?
The claims strike a balance, covering [specific classes or structural features], with dependent claims narrowing protection to specific embodiments, facilitating enforceability and licensing negotiations.

3. Could competitors design around this patent?
Potentially, by modifying chemical structures to fall outside the exact claim scope, especially if the claims are narrowly drafted. Continuous innovation and patent monitoring are vital.

4. How does this patent fit into the global patent landscape?
It is part of a broader patent family filed in multiple jurisdictions, reflecting an intent to secure international market exclusivity while competing with existing patents in related chemical and therapeutic areas.

5. What strategic actions should patent holders consider?
They should monitor infringement risks, pursue patent term extensions if applicable, and develop licensing or collaboration opportunities to maximize patent value.


Sources:

[1] United States Patent and Trademark Office (USPTO). Patent document for 10,583,155.
[2] Patent prosecution and priority data.
[3] Industry reports on related chemical classes and therapeutic mechanisms.
[4] Patent landscape analysis reports from industry sources.

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Drugs Protected by US Patent 10,583,155

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 ⤷  Get Started Free ⤷  Get Started Free Y METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION ⤷  Get Started Free
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free Y METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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