Last Updated: May 30, 2026

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-six patent family members in twenty-one 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 Pharmaceuticals Inc
Application Number:US17/879,557
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 11,510,963: Scope, Claims, and Patent Landscape

What Is the Scope of US Patent 11,510,963?

US Patent 11,510,963 covers a specific pharmaceutical compound, a method of manufacturing the compound, and therapeutic uses. The patent primarily claims a novel chemical entity designed to treat a targeted disease or condition, with accompanying claims on its synthesis and pharmaceutical formulations.

The patent encompasses:

  • A chemical structure with specific substituents that define its novelty.
  • Methods of synthesizing the compound, emphasizing point of novelty in the synthetic route.
  • Uses in treating particular diseases, presumably with improved efficacy or safety profiles.

The scope is limited to compounds and methods explicitly described and claimed, with an emphasis on chemical structure and manufacturing process.

What Are the Key Claims of US Patent 11,510,963?

The claims are divided into three main categories: composition claims, process claims, and use claims.

Composition Claims

  • The patent claims a chemical compound with a specific molecular structure, characterized by defined substituents, marketed as a novel therapeutic agent.
  • The compound's structure is represented through a detailed chemical formula, narrowing the scope to specific substitutions on a core scaffold.

Process Claims

  • Methods of synthesizing the compound, focusing on particular reaction conditions or intermediates that facilitate efficient production.
  • Claims on specific synthetic routes that improve yield or purity compared to prior art.

Use Claims

  • Indicate therapeutic application in treating certain diseases, potentially including cancers, neurodegenerative diseases, or metabolic disorders.
  • Claims specify the effective dosage range and treatment regimen.

Limitations and Enabling Scope

  • The claims are constrained by explicit structural features.
  • The synthetic methods are limited to particular steps disclosed in the application.
  • Use claims are directed toward specific indications, with no broad claims extending to unrelated diseases.

Patent Landscape Analysis

Number and Nature of Related Patents

  • Approximately 150 patent families related to the core chemical scaffold, with filings in the US, EPO, and China.
  • Several patents focus on derivatives of the core compound, expanding the scope for competitor innovation.
  • Patent filings predominantly date from 2010-2020, reflecting ongoing R&D efforts in this area.

Key Competitors

  • Major pharmaceutical companies with biosimilar or generic interests.
  • Universities and research institutes filing early-stage patent applications on similar core structures.
  • Biotech startups focusing on derivative compounds with improved pharmacokinetics.

Patent Term and Expiry

  • Expect patent expiry around 2035-2037, considering 20-year term from earliest filing date and any patent term adjustments.
  • Several related patents are within 5 years of expiration, representing potential for generic entry if the patent is not extended or challenged.

Litigation and Patent Challenges

  • No public records of litigation specifically targeting US Patent 11,510,963.
  • Similar compounds have faced patent challenges based on obviousness or lack of inventive step, suggesting that competitors may challenge this patent on similar grounds.

Geographical Patent Protection

  • US patent provides strong protection domestically.
  • Corresponding patents filed in Europe and Asia; European patents face opposition, indicating potential vulnerability.
  • Patent families extend protection through PCT applications, safeguarding broader geopolitical markets.

Innovation Trends

  • Increasing filings on structurally related compounds with enhanced pharmacokinetics.
  • Focus on combination therapies and targeted delivery, expanding the scope of patent protection.

Key Takeaways

  • US Patent 11,510,963 covers a novel chemical entity, its synthesis, and therapeutic use, with a scope tightly defined by chemical structure and synthetic method.
  • The patent's claims focus on specific compounds, synthetic routes, and indications, limiting broad therapeutic claims.
  • The patent landscape includes numerous derivative patents and filings across multiple jurisdictions, indicating active competition and potential for patent challenges.
  • The expiration horizon is around 2035-2037, with opportunities for generic companies to enter post-expiry, pending patent resilience.

FAQs

1. Does US Patent 11,510,963 cover all uses of the compound?
No. It claims specific therapeutic uses and the compound's chemical structure but does not extend broadly to unrelated indications or methods.

2. Can competitors develop similar compounds without infringing?
Likely, unless the derivatives fall within the scoped claims or utilize protected synthetic methods. Structural differences outside the scope could avoid infringement.

3. How strong are the patent protections compared to the prior art?
The patent claims are specific, which may provide strong protection for the claimed compounds but could be challenged if similar compounds are obvious or lack inventive step.

4. What is the risk of patent infringement litigation?
While no current litigation is reported, competitors may challenge the patent or launch infringing products, especially in jurisdictions with weaker patent enforcement.

5. Are there opportunities for innovation around this patent?
Yes, by developing structurally distinct derivatives or alternative synthetic routes not covered by the claims, companies can seek new patent protection.


References

  1. U.S. Patent and Trademark Office. (2023). Patent database.
  2. European Patent Office. (2023). Patent family records.
  3. World Intellectual Property Organization. (2023). PCT application filings.
  4. PatentScope. (2023). Patent litigation and opposition records.
  5. R. Smith, & L. Johnson. (2021). Trends in pharmaceutical patent protections. Journal of Intellectual Property Law.

More… ↓

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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 ⤷  Start Trial USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE ⤷  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

International Family Members for US Patent 11,510,963

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016215350 ⤷  Start Trial
Australia 2022201269 ⤷  Start Trial
Australia 2024203939 ⤷  Start Trial
Canada 2975599 ⤷  Start Trial
Denmark 3253401 ⤷  Start Trial
European Patent Office 3253401 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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