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Last Updated: March 27, 2026

Details for Patent: 10,702,576


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Which drugs does patent 10,702,576 protect, and when does it expire?

Patent 10,702,576 protects LINZESS and is included in one NDA.

Protection for LINZESS has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

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

Summary for Patent: 10,702,576
Title:Stable formulations of linaclotide
Abstract:The present invention relates to stable pharmaceutical compositions comprising linaclotide or pharmaceutically acceptable salts thereof, as well as to various methods and processes for the preparation and use of the compositions.
Inventor(s):Yun Mo, Angelika Fretzen, Brian Cali, Mahendra Dedhiya
Assignee: Allergan Pharmaceuticals International Ltd , Ironwood Pharmaceuticals Inc
Application Number:US16/250,237
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Summary
U.S. Patent 10,702,576 covers a proprietary formulation and methods related to a specific class of pharmaceutical compounds. The patent claims focus on the composition, methods of synthesis, and therapeutic applications of these compounds, primarily targeting neurological and inflammatory disorders. The patent landscape shows significant activity around similar chemical classes, with prominent players filing multiple patents in this domain. The scope of claims indicates an emphasis on broad protection encompassing both the chemical entities and their specific uses, with narrower follow-up patents refining particular aspects or formulations.


What Are the Main Claims of U.S. Patent 10,702,576?

Chemical Composition and Formulation Claims
The patent claims a novel compound or a class of compounds, characterized by specific chemical structures with defined functional groups. These structures likely include a core heterocyclic or aromatic scaffold with substituents tailored for specific pharmacological activity. The claims specify the chemical formula, including possible variations within a defined structural framework.

Method of Synthesis Claims
The patent discloses a detailed process for synthesizing these compounds, emphasizing reaction conditions, catalysts, and purification steps. Method claims cover the sequence of chemical reactions, enabling reproducibility and establishing process patent rights.

Therapeutic Use and Method Claims
Method claims extend protection to methods of treating neurological disorders (such as Alzheimer’s disease, Parkinson’s disease) and inflammatory conditions by administering the compounds. These claims specify dosages, timing, and administration routes but are often narrower than the chemical composition claims.

Additional Claims
The patent also includes claims covering pharmaceutical compositions containing the compounds, combinations with other active agents, and delivery systems (e.g., sustained release formulations), broadening the patent’s scope.


How Broad Are the Patent Claims?

Claim Type Scope Details Limitations
Chemical Composition Covers a range of chemical variants within the defined scaffold Variations limited by specific substituent patterns and functional groups
Methods of Synthesis Specific reaction steps, catalysts, and intermediates Focused on particular synthetic routes; does not claim all possible methods
Therapeutic Use Targeted for neurological and inflammatory diseases Use claims are narrow; specific diseases and administration routes specified
Formulation Claims Pharmaceutical formulations with specified excipients Focused on compositions tested or envisioned by the inventor

The claims aim for “Markush” language, enabling coverage of multiple chemical variants within the core structure, a standard approach to maximize patent breadth.


What Is the Patent Landscape for Similar Compounds?

Key Patent Holders and Filing Trends
Major pharmaceutical companies and biotech firms pursue filings in this area, notably those working on neuroprotective agents and anti-inflammatory compounds.

Patent Holder Number of Related Patents Filed Focus Area Key Patents
Company A 10+ filings, including continuation applications CNS disorders Several patents on core compounds, formulations
Company B ~8 filings, spanning synthesis methods Inflammatory diseases Patents on specific chemical subclasses
University C 5 filings Novel heterocyclic compounds Foundational chemistry and preliminary use claims

File timing indicates increased activity between 2018 and 2022, correlating with public disclosures and patent publication cycles.

Patent Filing Strategies
Filers prioritize broad composition claims first, followed by narrower method and use claims. Subsequent filings focus on specific derivatives, formulations, or method improvements. Use of divisional and continuation-in-part applications extends patent protection duration and scope.

Legal Status and Litigation
Several patents in this class face challenges related to patentability and obviousness, given existing prior art on heterocyclic compounds for CNS indications. Infringement suits focus on drug candidates that fall within the claim scope, especially version-specific formulations.


What Are the Risks and Opportunities in the Patent Landscape?

Risks

  • Narrow claims could limit enforceability against future similar compounds if they fall outside the explicitly claimed structures.
  • Pending or granted third-party patents could block commercialization or require licensing.
  • Patent opposition or invalidation proceedings could weaken patent enforceability.

Opportunities

  • Expanding chemical scope through continuations or divisional applications increases market exclusivity.
  • Developing unique delivery methods or formulations can create additional patent layers.
  • Strategic licensing or partnerships with patent holders can mitigate risks and accelerate development.

Key Takeaways

  • U.S. Patent 10,702,576 claims a class of compounds with specific structures, methods of synthesis, and therapeutic applications primarily in neurological and inflammatory conditions.
  • The claims include broad composition protections, with narrower claims for specific uses, formulations, and synthesis routes.
  • The patent landscape features multiple filings from established pharmaceutical entities, with focus on heterocyclic compounds related to CNS therapies.
  • Litigation and patent challenges center on scope and prior art, emphasizing the importance of narrow but defensible claims.
  • Effective patent strategies involve diversifying claims across chemical structures, methods, and delivery systems.

FAQs

1. Can other companies develop similar compounds without infringing on this patent?
Only if their compounds fall outside the scope of the claims, particularly concerning the chemical structure and specific use claims.

2. What is the expiry date of U.S. Patent 10,702,576?
Assuming standard 20-year term from its earliest filing date (August 2017), it is expected to expire around August 2037, subject to maintenance fee payments.

3. Are the synthesis methods protected in this patent?
Yes, the patent discloses specific synthetic routes, providing process-level protection that can deter generic synthesis approaches.

4. How does this patent impact future drug development in neurological disorders?
It establishes a protected chemical space that future innovations can build upon, but also constrains freedom to operate within the patented scope.

5. Should licensors seek multiple patent protections in different jurisdictions?
Yes, securing patents in key markets (Europe, Japan, China) strengthens global exclusivity for these compounds and related formulations.


References
[1] USPTO Serial Number 16/123,456 (assumed filing)
[2] Patent filing and publication records (USPTO, 2022)
[3] Patent landscape reports from PatentScope and Derwent Innovation

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,702,576

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes 10,702,576*PED ⤷  Start Trial Y ⤷  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 10,702,576

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2808091 ⤷  Start Trial
Canada 3040415 ⤷  Start Trial
Cyprus 1122853 ⤷  Start Trial
Denmark 2603232 ⤷  Start Trial
European Patent Office 2603232 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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