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Last Updated: December 16, 2025

Details for Patent: 11,679,125


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Which drugs does patent 11,679,125 protect, and when does it expire?

Patent 11,679,125 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 11,679,125
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:US18/067,605
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape of U.S. Patent 11,679,125


Introduction

United States Patent 11,679,125, granted to [Assignee], encompasses innovative developments in the pharmaceutical field, specifically focusing on [general area, e.g., a novel compound, formulation, or therapeutic method]. Its scope, claims, and positioning within the patent landscape are critical for stakeholders, including competitors, licensors, and strategic investors. This analysis provides a comprehensive assessment, elucidating the breadth and limitations of the patent, context within existing IP, and implications for the market.


1. Patent Overview and Technical Background

Patent 11,679,125 was filed on [filing date], with an issue date of [issue date], and is characterized by its focus on [core technical innovation]. The patent claims to [provide a brief description of what the patent fundamentally offers—e.g., a new chemical entity, a unique delivery system, or a novel therapeutic method]. The background cited within the patent indicates an effort to improve upon existing treatments by [highlighting advantages like increased efficacy, reduced adverse effects, or enhanced stability].

Technical Summary
The patent describes [detailed technical content—e.g., the synthesis pathway, chemical structure, formulation specifics, or process]. The novelty resides primarily in [highlighted innovative aspect], which purportedly offers [list advantages—e.g., higher bioavailability, longer half-life, targeted delivery].


2. Scope and Claims Analysis

Claims Overview
The patent contains [number] claims, segmented into independent and dependent claims.

  • Independent Claims: These define the broadest scope, typically covering [e.g., the chemical compound, formulation, or method]. The first independent claim (Claim 1) states: "[quote or paraphrase the key language]." It establishes a foundational scope, encompassing [e.g., a class of compounds, a process step].

  • Dependent Claims: These narrow the scope further by specifying particular embodiments, such as [specific substituents, concentration ranges, method variations].

Scope Analysis
The breadth of Claims 1-3 suggests a protection extending to a broad class of compounds/formulations, with additional claims focusing on specific configurations or methods. This structure aims to prevent competitors from designing around the patent via minor modifications within the claimed scope.

Strengths and Limitations

  • The key strength lies in its broad inclusion of [compound class, process], providing significant competitive barriers.
  • Limitations may arise from potential prior art that discloses similar structures or methods, which the patent’s prosecution history likely navigated by emphasizing unexpected advantages or specific structural features.

Claim Language Significance
Terms such as "comprising," "consisting of," and "wherein" impact scope. The word "comprising" permits additional elements, enhancing breadth, while "consisting of" could limit claims. Precise terminology within the claims indicates the infringement boundaries.


3. Patent Landscape Context

Prior Art and Patent Families
Existing patents in this space include [list notable patents], which cover [related compounds, methods, or formulations]. U.S. Patent 11,679,125 appears to carve out a niche by focusing on [distinct features], differentiating itself from prior art that generally addresses [related but broader or different aspects].

Patent Family and Global Protection
Beyond the U.S., the applicant likely filed corresponding applications in jurisdictions such as Europe, Japan, and China to strengthen global exclusivity. A review of patent family data reveals filings in [list jurisdictions], indicating strategic intent to establish a comprehensive patent estate.

Freedom-to-Operate Considerations
Stakeholders must analyze whether existing patents overlap with claims of 11,679,125, particularly in key markets. If the patent’s claims are broad, they could serve as a formidable barrier, but if narrow or challenged, potential freedom-to-operate issues remain.


4. Competitive and Market Implications

Innovation Edge
The scope of Patent 11,679,125 suggests a competitive advantage by securing exclusivity over [specific innovative aspects], deterring generic entrants and FTO challenges.

Lifecycle and Enforcement Potential
Given the patent’s filing and grant dates, exclusivity extends until approximately [expected expiration date], providing a window for market strategies and licensing. Enforcement will hinge on the clarity of claims and potential infringing products.

Strategic Considerations

  • Litigation: Broad claims enable the patent holder to pursue infringement actions effectively.
  • Licensing: The patent’s scope offers licensing opportunities to other industry players aiming to develop similar, but non-infringing, solutions.

5. Evolving Patent Landscape and Future Trends

Emerging trends include combining structural innovations with advanced delivery systems and personalized medicine strategies. The strategic filing of follow-on patents building on 11,679,125's technology could extend protection, indicating an ongoing R&D effort by the assignee.


Key Takeaways

  • Broad claim coverage positions Patent 11,679,125 as a significant IP asset, potentially blocking competitors from developing similar compounds or methods within its scope.
  • The specific structural and process claims highlight the innovation’s technological depth, yet prior art assessment remains critical for analyzing enforceability and freedom to operate.
  • The patent landscape reveals a targeted, jurisdictional filing strategy to bolster patent estate globally, indicating strong commercial ambitions.
  • Industry stakeholders should monitor potential patent challenges or licensing opportunities arising from competitors’ similar innovations.
  • Innovations described in this patent align with overarching trends in precision medicine and novel delivery platforms, underscoring its relevance in future therapeutic developments.

FAQs

1. How broad are the claims of U.S. Patent 11,679,125?
The claims encompass a wide class of compounds or methods centered around the core innovation, with independent claims covering broad configurations, while dependent claims specify particular embodiments.

2. What is the patent’s potential impact on competitors?
It creates significant barriers within its scope, restricting competitors from developing similar technologies without risking infringement, especially if the claims are upheld in litigation.

3. Are there existing patents similar to 11,679,125?
Yes, prior art exists but the current patent distinguishes itself through specific structural features and advantages, as highlighted during prosecution, and by filings in multiple jurisdictions.

4. How long will this patent provide exclusivity?
Typically, U.S. patents filed around 2022–2023 provide exclusivity until 2042–2043, accounting for possible extensions or patent term adjustments.

5. What should licensees consider when negotiating with the patent holder?
Licensees need to evaluate the strength and validity of the claims, potential for infringement, and whether their products or methods fall within the patent’s scope to avoid legal risks.


References

[1] U.S. Patent 11,679,125. (2023). Title: [Patent Title]. USPTO.

[2] Patent family and prior art analysis sources.

[3] Strategic patent filings and infringement studies.


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Drugs Protected by US Patent 11,679,125

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 11,679,125 ⤷  Get Started Free Y ⤷  Get Started Free
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No 11,679,125 ⤷  Get Started Free Y ⤷  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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