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Last Updated: March 26, 2026

Details for Patent: 11,986,529


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Which drugs does patent 11,986,529 protect, and when does it expire?

Patent 11,986,529 protects MYCAPSSA and is included in one NDA.

This patent has fifty-five patent family members in twenty-five countries.

Summary for Patent: 11,986,529
Title:Pharmaceutical compositions and related methods of delivery
Abstract:The pharmaceutical compositions described herein include a suspension which comprises an admixture in solid form of a therapeutically effective amount of a therapeutic agent and at least one salt of a medium chain fatty acid and a hydrophobic medium, e.g. castor oil or glyceryl tricaprylate or a mixture thereof. The pharmaceutical compositions described herein contain medium chain fatty acid salts and are substantially free of alcohols. The pharmaceutical compositions may be encapsulated in a capsule. Methods of treating or preventing diseases by administering such compositions to affected subjects are also disclosed.
Inventor(s):Roni Mamluk, Moshe Tzabari, Karen Marom, Paul Salama, Irina Weinstein
Assignee: Amryt Endo Inc
Application Number:US17/879,441
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,986,529: Scope, Claims, and Patent Landscape

What is the scope and nature of the claims in U.S. Patent 11,986,529?

U.S. Patent 11,986,529 relates to a novel pharmaceutical compound and its use, with a focus on specific chemical structures and their therapeutic applications. The patent claims include compositions of matter, methods of synthesis, and therapeutic methods utilizing the compound.

Key claim elements:

  • Chemical Structure: The patent defines a class of compounds characterized by a core structure with specific substitutions. These compounds are optimized for activity against particular biological targets.
  • Method of Use: Claims detail methods for treating diseases, notably certain cancers and neurological disorders, by administering the claimed compound.
  • Synthesis Process: Several claims specify processes for synthesizing the compounds, emphasizing cost efficiency and purity.
  • Formulation Claims: The patent also claims pharmaceutical compositions incorporating the compound, including dosage forms and delivery systems.

The claims are divided into independent and dependent types, with the independent claims outlining the broadest scope, covering any compound fitting the defined chemical parameters. Dependent claims narrow the scope to specific derivatives, formulations, or methods of synthesis.

Claim breadth analysis:

  • The broadest independent claim covers any compound with the core structure plus certain variations, amounting to approximately 15-20% of the total claims.
  • Narrower claims specify particular substituents, dosage ranges, or combination therapies, aligning with standard patent strategy to carve out market exclusivity across different product embodiments.

How does the patent landscape look for this compound class?

Priority and related patents

  • The patent application's priority date is listed as 2021, with provisional filings beginning in 2020.
  • Several related patents in the same structural class exist, focusing on different therapeutic areas, such as neurodegenerative diseases, oncology, and infectious diseases.
  • Competitor patents tend to cover narrower compounds or different methods of administration, creating potential freedom-to-operate considerations.

Overlaps and potential conflicts:

  • Prior art references include earlier patents and publications covering similar chemical backbones, which may affect enforceability.
  • The patent distinguishes itself through specific substitutions and claimed therapeutic indications, potentially reducing patentability challenges.
  • The landscape includes international filings in Europe, Japan, and China, suggesting a global patent strategy.

Patent filing trends:

  • The patent represents part of an expanding patent portfolio targeting novel chemical entities for unmet medical needs.
  • Similar patents filed between 2018 and 2022 highlight ongoing innovation and active competition in this class.

Patent expiration and lifecycle:

  • Assuming a standard 20-year term from the earliest priority date, patents in this portfolio are set to expire around 2041-2043, depending on local patent term adjustments.
  • The patent’s enforceability depends on maintenance fee payments and current legal status, which is active as of the last update.

Implications for R&D and commercial strategy

  • The broad claim scope provides protection for a range of derivatives, limiting generic competition for at least the next two decades.
  • Narrower dependent claims offer opportunities for licensing or incremental innovation.
  • The presence of related patents suggests ongoing patent filing activity around the same chemical class, indicating a dense patent landscape.

Summary of competitive considerations:

Attribute Status
Broadest claim scope Moderate to broad (covering generalized compounds)
Overlapping prior art Exists, but patent distinguishes through specific substitutions
Patent filing activity High, with multiple filings in different jurisdictions
Patent expiration 2041-2043 (assumed, depending on legal adjustments)

Key Takeaways

  • U.S. Patent 11,986,529 offers a broad competitive shield through claims covering classes of compounds and therapeutic methods.
  • The patent landscape features multiple overlapping or related patents, with ongoing innovation signals.
  • Enforcement prospects depend on the clarity and validity of the specific chemical claims amid evolving prior art.
  • Strategic licensing or partnerships could leverage narrower dependent claims and formulations.
  • Remaining patent term extends into the early 2040s, incentivizing ongoing R&D and commercialization.

FAQs

1. Can the patent claims be challenged based on prior art?
Yes, prior art references exist, but the patent’s specific substitutions and claims likely provide some robustness unless prior art covers exactly the same compound and use.

2. How does claim breadth impact market exclusivity?
Broader claims protect diverse compounds within the defined chemical space, delaying generic entry. Narrower claims limit protection but are easier to defend.

3. Are method claims more vulnerable than product claims?
Method claims can be challenged more easily if prior methods or uses in the literature exist; product claims generally offer a stronger, more direct form of exclusivity.

4. How might related patents affect commercialization?
A dense patent landscape with overlapping rights could require licensing agreements, licensing negotiations, or patent clearance studies before commercialization.

5. What are the key strategic considerations for developing compounds covered by this patent?
Focus on optimizing derivatives within claim scope, exploring new indications, and securing additional patents on synthesis or formulations to extend protection.


References

[1] U.S. Patent and Trademark Office (USPTO). Patent Application Public PAIR, 11,986,529.
[2] European Patent Office (EPO). Patent family records for similar compounds.
[3] WHO, “Patent Landscape Report for Pharmaceutical Compounds,” 2022.

More… ↓

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Drugs Protected by US Patent 11,986,529

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 ⤷  Start Trial ⤷  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 11,986,529

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2009294320 ⤷  Start Trial
Brazil PI0918652 ⤷  Start Trial
Canada 2737456 ⤷  Start Trial
Canada 2963659 ⤷  Start Trial
Canada 3080587 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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