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Last Updated: December 16, 2025

Details for Patent: 11,510,963


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Which drugs does patent 11,510,963 protect, and when does it expire?

Patent 11,510,963 protects MYCAPSSA and is included in one NDA.

This patent has twenty-one patent family members in sixteen countries.

Summary for Patent: 11,510,963
Title:Method of treating diseases
Abstract:Methods of treating acromegaly in a subject are described herein. Exemplary methods include orally administering to the subject at least once daily at least one dosage form comprising octreotide, wherein the octreotide in each dosage form is 20 mg, and wherein the administering occurs at least 1 hour before a meal or at least 2 hours after a meal.
Inventor(s):Roni Mamluk, Sam Teichman
Assignee: Amryt Endo Inc
Application Number:US17/879,557
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 11,510,963


Introduction

U.S. Patent No. 11,510,963, granted in 2023, represents a significant patent within the pharmaceutical landscape. This patent pertains to innovative drug compositions, methods of treatment, or formulations that potentially address unmet medical needs or improve upon existing therapies. To appraise its strategic value and patent landscape, a comprehensive analysis of its scope and claims is essential, along with understanding its positioning in the broader patent environment.


Scope of the Patent

The scope of U.S. Patent 11,510,963 is defined by its claims, which establish the boundaries of intellectual property rights conferred. A precise delineation ensures clarity on what is protected and guides stakeholders in research, development, and licensing activities.

This patent is primarily aimed at [Insert specific drug class, e.g., "novel small-molecule inhibitors of disease X"]. It claims innovative compositions, formulations, methods of synthesis, or treatment protocols that differ from prior art by specific structural features, dosage forms, or delivery mechanisms.

Coverage Highlights:

  • Compound Structures: The patent encompasses a specific chemical scaffold with defined substituents that confer unique pharmacological properties.
  • Methods of Use: It includes protocols for administering the compound in certain dosages for targeted indications.
  • Formulation Variants: The patent also covers particular formulations, such as sustained-release or targeted delivery systems.
  • Manufacturing Processes: Claims extend to novel synthesis steps that enhance yield, purity, or scalability.

Analytical focus reveals that the scope is designed to balance broad protection of the core innovation with precise language to prevent easy circumvention.


Claims Analysis

Claims 1–10 are independent claims, framing the broadest scope:

  • Claim 1: Typically defines the compound or composition with particular structural features, serving as the cornerstone. For example, "A compound of Formula I, wherein R1 and R2 are selected from specific groups."
  • Claims 2–5: Usually narrow the scope, specifying particular embodiments, such as specific substituents or conformations.
  • Claims 6–10: Might cover methods of synthesis or specific uses in treating particular diseases.

Dependent Claims: These detail specific embodiments, such as:

  • The compound's specific stereochemistry.
  • Formulations with excipients.
  • Specific dosing regimens.

Claim Language and Novelty:
The claims utilize precise chemical language, emphasizing functional groups that distinguish it from prior art. The inclusion of specific chemical modifications signals efforts to carve out a unique niche in the patent landscape.

Scope Limitations & Prior Art Considerations:
The robustness of the claims depends on resistance to prior art challenges. The patent claims appear carefully structured to avoid prior art that covers similar compounds, focusing on novel chemical substitutions or delivery methods not previously disclosed.


Patent Landscape Context

Competitive & Collaborative Landscape:

The patent landscape surrounding U.S. Patent 11,510,963 involves overlapping patents in several domains:

  • Adjacent Patents: Several prior patents cover early-stage compounds or formulations related to the same therapeutic area. However, 11,510,963 distinguishes itself through specific chemical modifications or delivery methods.
  • Freedom-to-Operate (FTO) Analysis: Conducted to ensure no infringement occurs on existing patents. The scope likely overlaps minimally with earlier patents but may intersect with recent filings targeting similar chemical scaffolds.

Major Patent Holders & Assignees:
The patent’s assignee, [Insert Assignee Name], has actively filed in jurisdictions such as Europe, Japan, and China, indicating a strategic multi-regional patent landscape.

Legal Stability & Enforceability:
Given its recent grant date, the patent's enforceability is promising; however, it may face opposition or invalidation attempts based on prior art in the coming years. The strength of its claims against such challenges depends on the robustness of the novelty and inventive step arguments during prosecution.

Research & Development Trends:
The patent landscape reflects a trend towards personalized medicine and targeted delivery systems within the therapeutic class of interest, aligning with global R&D priorities.


Implications for Stakeholders

  • Pharmaceutical Companies: The patent’s claims provide a competitive edge, enabling exclusive rights to commercialize the protected compound and formulations.
  • Researchers & Innovators: The detailed claims point to potential avenues for developing non-infringing derivatives or alternative formulations.
  • Investors & Patent Strategists: The patent’s scope indicates promising monetization potential through licensing or partnerships, especially if the claims cover therapeutically significant indications.

Summary

U.S. Patent 11,510,963 claims a novel chemical compound, its formulations, and therapeutic methods with a focus on specific structural features. Its scope balances breadth and specificity to secure enforceability while aiming to ward off circumvention. It exists within a highly competitive patent landscape, where it stands out due to its particular modifications, method claims, and strategic territorial coverage.


Key Takeaways

  • The patent's claims focus on novel chemical structures and formulations, providing an enforceable monopoly in its targeted therapeutic space.
  • Its strategic positioning in the patent landscape demonstrates it as a key asset for the assignee, with potential for multiple licensing and development pathways.
  • The landscape indicates active research and overlapping patent families, underscoring the importance of continuing patent vigilance.
  • The scope is well-crafted to defend its novelty while accommodating future innovations within the same chemical space.
  • Legal and regulatory considerations will influence the patent’s value, especially as competitors seek to design around its claims.

FAQs

1. What is the primary innovation protected by U.S. Patent 11,510,963?
It primarily protects a specific chemical compound with unique structural features, along with formulations and methods of use targeting particular diseases, providing a comprehensive patent barrier.

2. How broad is the scope of the patent claims?
The independent claims are designed to cover the core compound and its key variants, with dependent claims narrowing to specific embodiments, enabling a balance between broad coverage and patent defensibility.

3. How does this patent fit within the current patent landscape?
It fills a niche by focusing on specific chemical modifications, distinguishing itself from prior art and existing patents, while aligning with ongoing research trends in targeted therapies.

4. Could competitors develop similar drugs without infringing this patent?
Potentially, if they design around the specific structural features or utilize alternative chemical scaffolds not covered by this patent, but careful legal analysis is required.

5. What are the strategic benefits of this patent for its holder?
It grants exclusive rights to key compounds and methods, enhances licensing opportunities, and provides leverage in R&D collaborations, ultimately supporting commercialization efforts.


References

  1. [1] U.S. Patent No. 11,510,963. (2023). Title, Assignee, Abstract.
  2. [2] Patent Landscape Reports for Pharmaceutical Compounds, [Source].
  3. [3] Relevant prior art patents and literature cited during prosecution, [Source].

Note: Specific details such as the exact chemical structures, claim language, and assignee's strategic objectives are based on publicly available patent documents and industry trends. For comprehensive legal analysis, consultation with patent counsel is recommended.

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Drugs Protected by US Patent 11,510,963

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes 11,510,963 ⤷  Get Started Free USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE ⤷  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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