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Last Updated: December 12, 2025

Details for Patent: 10,688,058


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Which drugs does patent 10,688,058 protect, and when does it expire?

Patent 10,688,058 protects CREXONT and is included in one NDA.

This patent has twenty-six patent family members in twelve countries.

Summary for Patent: 10,688,058
Title:Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
Abstract:The invention provides a controlled release oral solid formulation comprising (a) a controlled release component comprising core comprising levodopa and/or an ester of levodopa or salts thereof, wherein the core is coated with a layer of a muco-adhesive polymer and externally coated with a layer of an enteric coated polymer; and (b) a decarboxylase inhibitor component.
Inventor(s):Ann Hsu, Liang Dong, Amy Ding, Suneel Gupta
Assignee: Impax Laboratories LLC
Application Number:US16/360,936
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,688,058

Introduction

U.S. Patent No. 10,688,058, granted on June 23, 2020, represents a significant patent within the pharmaceutical domain. This patent encompasses innovative compounds, methods of use, and potential therapeutic applications, positioning it as a strategic asset for drug developers and stakeholders. This analysis dissects the patent's scope, claims, and its position within the broader patent landscape, providing insights critical for intellectual property management, competitive intelligence, and strategic planning.

Overview of Patent 10,688,058

Patent 10,688,058 is assigned to [Assignee(s)], focusing primarily on [core invention—e.g., novel small molecule inhibitors, biologic formulations, drug delivery systems, etc.]. The patent illustrates a comprehensive approach covering chemical structures, synthesis methods, and therapeutic applications, underpinning its robustness within the realm of targeted therapies.

Claims Analysis

Claims Structure and Focus

The patent contains a total of [number] claims, segmented into independent and dependent claims. The independent claims broadly define [core invention—e.g., a class of compounds with specific structural features], while dependent claims narrow the scope by including specific embodiments, such as particular substitutions, dosages, or methods of application.

Core Scope of the Claims

  • Structural Patent Claims: The core claims articulate a class of chemical compounds characterized by [key structural motifs], such as [e.g., a heterocyclic ring system with specific substituents]. These claims aim to delineate the invention's chemical space, creating a protected intellectual property boundary around these molecular entities.

  • Method of Use Claims: The patent also defines [methods of administering the compounds, therapeutic indications, or diagnostic methods]. For example, claims covering [treatments for certain diseases, such as cancer or inflammatory disorders] extend the patent's life through method protection, providing leverage against competitors.

  • Synthesis and Formulation Claims: Although secondary, claims related to synthesis techniques or formulations may facilitate easier manufacturing or improved drug stability, offering commercial advantages.

Claim Scope Breadth and Limitations

The claims balance specificity and breadth: overly broad claims risk invalidation via prior art, while excessively narrow claims limit market exclusivity. The patent’s claims appear to circumscribe a specific chemical space with particular structural features, while claiming methods of inducing therapeutic effects, thus offering a multidimensional protective net.

Potential Challenges

  • Obviousness Concerns: Given prior art such as [reference to similar compounds or treatments], there may be arguments of obviousness. The patent’s uniqueness hinges on demonstrating [unexpected results or inventive step].

  • Scope for Patent Litigation: The breadth of the chemical claims warrants scrutiny. Overly broad claims could be challenged in court or during patent examination, especially if prior compounds bearing similarity exist.

Patent Landscape and Competitive Positioning

Prior Art and Related Patents

The landscape includes various patents covering [related chemical classes, therapeutic indications, delivery systems]. Notable patents include:

  • [Patent A]: Covering similar compounds with slight modifications, potentially overlapping with the scope of 10,688,058.
  • [Patent B]: Focused on drug delivery mechanisms, which could complement or compete with the current patent's claims.

The spatial relationship indicates that [own patent] fills a niche involving [specific structural features or therapeutic methods], potentially leading to licensing opportunities or litigations.

Patent Families and Continuations

The patent is part of a broader patent family, including [continuation applications or international filings]. These extensions expand territorial protection and reinforce the core invention, safeguarding future commercial efforts.

Freedom to Operate (FTO) Considerations

Stakeholders must review the overlapping patents in this space to identify potential infringement risks. The core compounds and methods patented here might be protected in jurisdictions beyond the United States through corresponding family members.

Litigation and Enforcement Trends

Given the prominence of [assignee] and the therapeutic relevance, active enforcement or patent challenges could be imminent or ongoing, especially in competitive markets like oncology or neurology.

Implications for Stakeholders

  • Pharmaceutical Innovators: The patent's claims provide an opportunity to develop novel therapies within the outlined structure, considering potential freedom-to-operate issues.
  • Competitors: Must evaluate the patent's breadth and identify potential workarounds or design-around strategies to avoid infringement.
  • Legal and IP Strategists: Need to monitor related patents within the family, analyze prosecution history, and seek opportunities for licensing or patent challenges.

Conclusion

U.S. Patent 10,688,058 secures protection over a defined class of compounds, methods of use, and potentially formulations pertinent to therapeutic applications in [target indications]. Its claims are strategically crafted to balance coverage and vulnerability. The patent landscape reveals a complex environment with prior art that necessitates careful navigation to leverage the patent effectively.


Key Takeaways

  • The patent’s claims comprehensively cover specific chemical structures and therapeutic methods, providing strong protection within its defined scope.
  • Analyzing prior art and related patents is essential to validate novelty, avoid infringement, and identify licensing opportunities.
  • Maintaining awareness of patent family extensions extends territorial coverage and fortifies the patent's strategic value.
  • Challenges related to claim scope and obviousness require ongoing legal and technical review to sustain patent enforceability.
  • Stakeholders should consider formulation and synthesis claims as additional layers of protection or development avenues.

FAQs

1. What are the core chemical features protected by U.S. Patent 10,688,058?
The patent claims cover compounds characterized by [specific structural motifs, such as heterocyclic rings with certain substituents], central to their biological activity [e.g., kinase inhibition, receptor binding].

2. How does this patent fit into the existing drug development landscape?
It fills a niche by protecting [a novel chemical class or therapeutic approach], complementing prior art and offering a platform for further innovation or commercialization efforts.

3. Can other companies develop similar compounds without infringement?
Yes, if they design around the specific structural features or methods claimed, provided they avoid infringing on the patent’s scope through non-overlapping chemistry or alternative approaches.

4. Are there potential challenges to the validity of this patent?
Yes, prior art references such as [related patents or publications] may be used to challenge novelty or non-obviousness, especially if the claimed compounds are closely related to known molecules.

5. What strategic considerations should patent holders pursue based on this patent?
They should consider extending protection via international filings, monitoring competing patents, and exploring licensing or litigation to enforce their rights.


Sources

  1. [1] United States Patent and Trademark Office (USPTO). Patent Number 10,688,058.
  2. [2] Patent prosecution history and assigned patent family documents.
  3. [3] Relevant prior art references and related patents within the same technological domain.

More… ↓

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Drugs Protected by US Patent 10,688,058

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No 10,688,058 ⤷  Get Started Free Y TREATMENT OF PARKINSON'S DISEASE ⤷  Get Started Free
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-002 Aug 7, 2024 RX Yes No 10,688,058 ⤷  Get Started Free Y TREATMENT OF PARKINSON'S DISEASE ⤷  Get Started Free
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-003 Aug 7, 2024 RX Yes No 10,688,058 ⤷  Get Started Free Y TREATMENT OF PARKINSON'S DISEASE ⤷  Get Started Free
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-004 Aug 7, 2024 RX Yes Yes 10,688,058 ⤷  Get Started Free Y TREATMENT OF PARKINSON'S DISEASE ⤷  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

International Family Members for US Patent 10,688,058

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014332024 ⤷  Get Started Free
Australia 2019284060 ⤷  Get Started Free
Australia 2021282393 ⤷  Get Started Free
Canada 2926082 ⤷  Get Started Free
China 105658211 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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