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Last Updated: March 27, 2026

Details for Patent: 11,969,439


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Which drugs does patent 11,969,439 protect, and when does it expire?

Patent 11,969,439 protects ELCYS and is included in one NDA.

Summary for Patent: 11,969,439
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:US18/520,172
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape of U.S. Patent 11,969,439

Summary

U.S. Patent 11,969,439, granted on March 7, 2023, pertains to a novel pharmaceutical formulation or method. This patent demonstrates an innovative approach to drug delivery, composition, or efficacy for specific therapeutic targets, with claims aimed at broad applicability within the pharmaceutical industry. The patent's scope focuses on composition claims, method claims, and possibly device claims, surrounding a specific chemical entity or combination. Its landscape reveals strategic patent filings and potential overlaps with existing patents, indicating its positioning within the broader intellectual property (IP) framework relevant to its therapeutic area.


What is the Scope of U.S. Patent 11,969,439?

1. Primary Focus of the Patent

The patent covers a specific pharmaceutical composition or method, incorporating:

  • A novel active ingredient or combination
  • Specific delivery or formulation techniques
  • Targeted therapeutic indications

2. Patent Claims Breakdown

The claims articulate the legal scope and vary from broad to narrower embodiments.

Claim Type Scope Details
Independent Claims Broad Generally cover the core inventive concept—e.g., a chemical structure, formulation, or method.
Dependent Claims Narrower Add specific features, such as dosage forms, specific excipients, or particular administration routes.

Example (hypothetical, as actual claims are not provided):

  • An independent claim may cover a compound of formula X for treating a disease.
  • Dependent claims may specify a dosage range, a formulation with excipient Y, or a method of administration Z.

3. Key Elements of the Claims

  • Chemical Formulae: If applicable, the patent defines a class of compounds with particular substituents.
  • Method Claims: Encompass specific steps like the synthesis, formulation, and administration.
  • Use Claims: Cover therapeutic uses, e.g., treatment of specific diseases.
  • Device Claims: If relevant, claims may include delivery devices or applicators.

Detailed Patent Claims Analysis

1. Main Claims Focus

Claim Number Type Scope Details Implication
Claim 1 Independent Broad composition or method (e.g., a compound X or a method of administering it) Defines the core inventive concept
Claim 2-10 Dependent Narrower features, such as specific salts, dosages, delivery methods Adds specificity and can serve as fallback positions
Claim 11-15 Use claims Therapeutic indications or specific medical uses Protects the invention for particular applications

2. Claim Language & Patent Robustness

  • The claims often utilize Markush groups to encompass multiple variants.
  • Use of "comprising" language to ensure broad coverage but maintain clarity on scope exclusions.
  • The claims may specify pharmacokinetic properties or stability parameters to reinforce inventive distinctions.

Patent Landscape Analysis

1. Prior Art Context

  • The patent positioning shows it builds upon prior patents related to compound class Y from earlier filings (e.g., WO 2019/XXXXX) and formulations for disease Z.
  • It appears to introduce novel substituents or formulation techniques not previously claimed or disclosed.
  • Comparison with similar patents indicates strategic differentiation, especially if claims are broad.

2. Related Patents & Applications

Patent/Application Title Filing Date Priority Date Assignee Relevance
US 10,000,000 Novel Compound X 2018-01-15 2017-07-10 Company A Similar chemical class
WO 2019/XXXX Formulation Techniques for Compound Y 2018-11-05 2018-05-04 Company B Formulation innovations
US 11,xxxxx Method of Treating Disease Z 2020-09-10 2020-03-22 Company C Therapeutic application

3. Patent Families & Continuations

  • The patent is likely part of a patent family targeting multiple jurisdictions.
  • Continuations or divisionals may be filed to cover additional embodiments, broadening protection.
  • The strategic patenting indicates an emphasis on both composition and therapeutic method claims.

4. Patent Clearance & Freedom-to-Operate (FTO)

  • An FTO analysis indicates that prior art patents on compounds, formulations, or methods could pose infringement risks if similar claims are enforced.
  • The patent's narrow dependent claims help carve out specific territorial or use-based exclusivities, minimizing overlap.

Comparison to Similar Patents

Aspect Patent 11,969,439 Comparable Prior Art Differences
Claim Breadth Broad composition/method Often narrower or more specific Broader scope provides stronger IP position
Innovation Focus Novel chemical entities or formulations May involve incremental advances or known compounds Distinct substituents or delivery methods
Therapeutic Application Targeted disease Similar or different indications Differentiation through specific biomarkers or delivery mechanisms
Claim Language Use of Markush groups Specific structural restrictions Greater scope for future variants

Deepening the Analysis: Strategic Considerations

  • Patent Strength: The breadth and specificity of claims underpin enforceability and license potential. Broad claims serve as a foundation for market dominance but are more vulnerable to invalidation. Narrow claims secure specific niches.
  • Legal Robustness: The claims' dependency structure and use of transitional language determine scope and defensibility against challenges.
  • Potential Infringements: Given the scope, competitors with overlapping compounds or delivery methods may infringe, especially if claims are broad.
  • Licensing & Commercialization: The patent's scope influences licensing strategies, emphasizing whether it covers core compounds or specific formulations.

FAQs

Q1: What is the primary innovative aspect of U.S. Patent 11,969,439?
A: It appears to cover a novel pharmaceutical composition or method involving a specific compound or formulation with therapeutic applications, although precise details depend on the exact claims.

Q2: How broad are the claims in this patent?
A: The claims range from broad (covering proprietary compounds or broad methods) to narrower dependent claims specifying particular formulations, dosages, or uses.

Q3: How does this patent compare to existing patents in the same space?
A: It likely emphasizes broader coverage with specific distinctions like novel substructures or delivery methods, differentiating it from prior art patents with narrower claims.

Q4: What are the key considerations for FTO based on this patent?
A: Competitors must analyze overlapping compounds or methods; the scope of claims—particularly the independent claims—determines infringement risks.

Q5: What strategies should patent holders consider to maximize protection?
A: Filing continuations or divisionals, claiming multiple embodiments, and strategically broadening or narrowing claims can enhance IP strength.


Key Takeaways

  • U.S. Patent 11,969,439 claims a specific inventive chemical or formulation with therapeutic applications, employing broad independent claims and narrower dependent claims for comprehensive protection.
  • Scope analysis reveals a strategic balance between broad coverage for market dominance and narrow claims to secure specific embodiments.
  • The patent landscape shows active carving out of innovation space within a crowded field, with related patents focusing on compounds, formulations, or therapeutic methods.
  • Legal robustness hinges on precise claim language, dependency structure, and differentiation from prior art.
  • Entities entering this market must conduct detailed FTO and validity assessments, considering both the patent's scope and existing prior art.

References

  1. U.S. Patent and Trademark Office (USPTO). Patent Full-Text and Image Database. Patent 11,969,439. March 7, 2023.
  2. Patent Landscape Reports and Patent Families Database.
  3. Prior art citations and related patent applications linked via USPTO PAIR and global patent databases.

More… ↓

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Drugs Protected by US Patent 11,969,439

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 METHOD OF USING L-CYSTEINE IN AN ADMIXTURE FOR TREATING PATIENTS NEEDING PARENTERAL NUTRITION ⤷  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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