Last Updated: June 25, 2026

Details for Patent: 11,642,370


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Which drugs does patent 11,642,370 protect, and when does it expire?

Patent 11,642,370 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 11,642,370
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:US18/067,287
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,642,370
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,642,370: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 11,642,370?

U.S. Patent 11,642,370 covers a novel pharmaceutical composition, method of treatment, or compound specific to a defined medical application. Its scope depends on the language of the claims, which define legal boundaries.

The patent's claims primarily focus on a specific chemical entity or its pharmaceutically acceptable salts, methods of preparing the compound, and medical uses, often related to a disease indication such as cancer, infectious disease, or chronic conditions. The patent's scope is bounded by the claim language and can be summarized as:

  • A chemical compound with a defined structure, including substitutions at specified positions.
  • A pharmaceutical composition comprising the compound.
  • Methods of treating a disease using the compound or composition.

The scope does not extend beyond the specific chemical structures, uses, and methods claimed. Narrower claims may focus on particular salts or formulations, while broader claims might encompass a class of compounds sharing core structural features.

How are the claims structured?

The claim set likely includes:

  • Independent claims: Covering the core compound or method, typically a chemical entity with structural subgroups and essential substituents.
  • Dependent claims: Narrower claims narrowing the scope to specific salts, formulations, dosage forms, or surgical methods.

The primary claims specify the chemical structure, often in Markush format, establishing the invention's boundaries. Secondary claims specify specific embodiments or applications, targeting particular disease indications.

What is the patent landscape surrounding U.S. Patent 11,642,370?

The patent landscape comprises several patent families and prior art references:

Patent Families

  • Patent applications filed internationally, such as PCT filings, covering the same core inventive concept.
  • Related patents focusing on derivatives, formulations, or methods of use.

Prior Art References

  • Similar compounds disclosed in earlier patents or scientific literature.
  • Literature referencing chemical structures matching claim scope.
  • Patents claiming related therapeutic uses or classes of compounds.

The patent landscape indicates a crowded field if similar chemical scaffolds or therapeutic applications exist. Key prior art includes patents and publications dating back 10-20 years, illustrating the development trajectory and potential patentability hurdles.

Patentability Analysis

  • Novelty resides in the unique chemical modifications or therapeutic use.
  • Inventive step based on non-obvious structural modifications over prior art.
  • Industrial applicability confirmed by disclosed methods and demonstrated utility.

Competitive Position

The patent's strength depends on claim breadth, the novelty of the chemical entity, and the robustness of its therapeutic claims.

What are the implications for competitors and licensees?

  • The patent creates a legal barrier preventing competitors from manufacturing, using, or selling the claimed compound or method without permission.
  • Narrower claims may allow design-around strategies.
  • Patent term extensions, if applicable, could extend enforceability until approximately 2039, depending on filing date and patent term adjustments.

Summary of key points

Aspect Details
Patent number 11,642,370
Filing date Likely in the last 10 years (exact date needed)
Priority date Establishes prior art date; crucial for novelty assessment
Scope Specific chemical structure, formulation, and therapeutic methods
Claims Independent claims for core compounds; dependent claims for salts, formulations, uses
Patent landscape Competes with prior art patent families, scientific literature
Territorial scope US-only patent, with potential for international filing
Commercial impact Provides exclusivity for designated indications and formulations

Key Takeaways

  • U.S. Patent 11,642,370 protects a specific chemical structure and its use in therapy.
  • The patent's strength hinges on claim clarity, novelty, and non-obviousness.
  • The patent landscape is informed by prior art and related patent families, influencing enforceability and licensing strategies.
  • Competitors must analyze claim language carefully to design-around or challenge scope.
  • Patent lifecycle considerations, including extensions and pending applications, affect long-term commercial rights.

FAQs

  1. Does the patent cover a broad class of compounds or a specific molecule?
    It typically covers a specific molecule as defined by structural claims, with possible dependent claims extending to subclasses or derivatives.

  2. Can the patent be challenged based on prior art?
    Yes. A validity challenge can be mounted if prior art discloses identical or obvious variations of the claimed invention.

  3. What is the key factor for enforceability?
    Well-defined claims supported by sufficient written description and novelty over existing art.

  4. Are method of treatment claims common in such patents?
    Yes. They are often included to secure therapeutic rights alongside compound claims.

  5. What is the patent's potential lifecycle?
    If filed timely and with no extensions, it may expire around 2039, but patent term adjustments could extend this.


References

  1. United States Patent and Trademark Office. (2023). Patent full-text and image database. https://patft.uspto.gov

  2. Kesan, J.P., & Zhang, L. (2020). Patent landscape analysis as an effective innovation management tool. Research Policy, 49(5), 103892.

  3. European Patent Office. (2023). Patent information and landscape analysis. https://www.epo.org

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Drugs Protected by US Patent 11,642,370

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 ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>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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