You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 24, 2024

Details for Patent: 10,905,714


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,905,714 protect, and when does it expire?

Patent 10,905,714 protects ELCYS and NOURESS and is included in two NDAs.

Summary for Patent: 10,905,714
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:16/850,962
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 10,905,714

Introduction to Patent 10,905,714

United States Patent 10,905,714, titled "Stable, highly pure L-cysteine compositions for injection and methods of use," is a significant patent in the pharmaceutical field. This patent addresses the development and use of stable and highly pure L-cysteine compositions, which are crucial for various medical applications.

Overview of L-Cysteine

L-cysteine is an amino acid that plays a vital role in the synthesis of proteins and is used in numerous pharmaceutical and medical products. Its stability and purity are critical for ensuring the efficacy and safety of these products.

Scope of the Patent

Composition and Stability

The patent describes compositions of L-cysteine that are stable and highly pure, specifically designed for injection. These compositions are formulated to minimize degradation and ensure consistent quality, which is essential for medical use[1].

Pharmaceutical Acceptability

The patent emphasizes the use of pharmaceutically acceptable forms of L-cysteine, ensuring that the compositions meet the stringent standards required for medical applications. This includes considerations for solubility, pH stability, and compatibility with other pharmaceutical ingredients[1].

Claims of the Patent

Key Claims

  • Composition Claims: The patent claims cover specific compositions of L-cysteine that are stable and highly pure. These claims define the exact formulation and characteristics of the L-cysteine compositions, including the presence of specific additives or stabilizers[1].
  • Method Claims: The patent also includes method claims related to the preparation and use of these L-cysteine compositions. This includes methods for synthesizing, purifying, and administering the L-cysteine compositions[1].

Claim Specificity

The claims are detailed and specific, outlining the exact concentrations of L-cysteine, the types of solvents used, and any additional components that enhance stability. For example, the patent might specify the use of aluminum or other stabilizers to maintain the purity and stability of the L-cysteine solution[1].

Patent Landscape

Prior Art

To understand the novelty and non-obviousness of Patent 10,905,714, it is essential to review prior art in the field. This involves searching existing patents and publications related to L-cysteine compositions and their use in medical applications. The USPTO's patent database and the Patent Public Search tool are valuable resources for conducting such searches[5].

Competing Patents

The patent landscape includes other patents related to amino acid compositions and their medical applications. Analyzing these patents helps in identifying gaps and opportunities in the current intellectual property landscape. For instance, other patents might cover different methods of purification or stabilization, but the unique combination and formulation in Patent 10,905,714 distinguish it from existing patents[3].

Intellectual Property Protection

Claim Coverage

The claims in Patent 10,905,714 define the scope of protection for the invention. These claims are crucial for determining what aspects of the L-cysteine compositions are protected and what would constitute infringement. Using tools like Claim Coverage Matrix and Claim Charts can help in understanding the extent of this protection and identifying any gaps or opportunities for further innovation[3].

Enforcement and Litigation

The patent holder can enforce the rights granted by this patent by preventing others from making, using, offering for sale, or selling the specified L-cysteine compositions. Any infringement would need to be addressed through legal action, and the specificity of the claims would be pivotal in such proceedings[5].

Practical Applications

Medical Use

The stable and highly pure L-cysteine compositions described in the patent are designed for injection, making them suitable for various medical treatments. These compositions can be used in therapies requiring precise and reliable amino acid delivery, such as in the treatment of certain metabolic disorders or as part of parenteral nutrition[1].

Manufacturing Considerations

The methods described in the patent for preparing and purifying L-cysteine are critical for manufacturers. Ensuring the stability and purity of these compositions during the manufacturing process is essential for maintaining the quality and efficacy of the final product[1].

Future Directions and Opportunities

Research and Development

The patent opens up avenues for further research and development in the field of pharmaceutical amino acid compositions. Future innovations could focus on improving the stability and purity of L-cysteine compositions or exploring new applications for these compositions[3].

Market Impact

The unique formulations and methods described in the patent could have a significant impact on the market for pharmaceutical amino acid products. Companies holding this patent could leverage their intellectual property to dominate the market and set new standards for quality and efficacy[3].

Key Takeaways

  • Stable Compositions: The patent describes stable and highly pure L-cysteine compositions suitable for medical injection.
  • Specific Claims: The claims are detailed and specific, covering both the composition and methods of use.
  • Intellectual Property Protection: The patent provides strong intellectual property protection, defining the scope of protection and enforcement.
  • Practical Applications: The compositions have significant practical applications in medical treatments and manufacturing.
  • Future Directions: The patent offers opportunities for further research and development, potentially impacting the market for pharmaceutical amino acid products.

FAQs

Q: What is the main focus of United States Patent 10,905,714? A: The main focus is on stable and highly pure L-cysteine compositions for injection and their methods of use.

Q: Why is the stability and purity of L-cysteine important? A: Stability and purity are crucial for ensuring the efficacy and safety of L-cysteine compositions in medical applications.

Q: How do the claims in the patent define its scope of protection? A: The claims specify the exact formulation, characteristics, and methods related to the L-cysteine compositions, defining what is protected under the patent.

Q: What tools can be used to analyze the patent landscape for this invention? A: Tools such as Claim Coverage Matrix and Claim Charts, along with the USPTO's patent database and Patent Public Search tool, can be used to analyze the patent landscape.

Q: What are the potential future directions for research and development based on this patent? A: Future research could focus on improving the stability and purity of L-cysteine compositions or exploring new medical applications.

Sources

  1. US10905714B1 - Stable, highly pure L-cysteine compositions for injection and methods of use - Google Patents
  2. U.S. Patent and Trademark Office (USPTO) | USAGov
  3. Patent Analytics | Intellectual Property Law - Schwegman
  4. How to Search for an Historical U.S. Patent - NYPL Libguides
  5. Patents | The Maryland People's Law Library

More… ↓

⤷  Subscribe


Drugs Protected by US Patent 10,905,714

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 10,905,714 ⤷  Subscribe Y ⤷  Subscribe
Baxter Hlthcare Corp NOURESS cysteine hydrochloride SOLUTION;INTRAVENOUS 212535-001 Dec 13, 2019 DISCN Yes No 10,905,714 ⤷  Subscribe Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.