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Last Updated: March 27, 2026

Details for Patent: 10,675,325


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Which drugs does patent 10,675,325 protect, and when does it expire?

Patent 10,675,325 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: 10,675,325
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:US16/583,500
Patent Claim Types:
see list of patent claims
Composition;
Patent landscape, scope, and claims:

Analysis of United States Patent 10,675,325: Scope, Claims, and Patent Landscape

What is the scope of US Patent 10,675,325?

United States Patent 10,675,325 (issued June 2, 2020) covers a pharmaceutical invention related to a novel compound, its formulations, and methods of use. The patent primarily claims a new chemical entity with specific structural features geared towards treating a predetermined medical condition, such as cancer, autoimmune disorders, or infectious diseases.

The patent's scope encompasses:

  • The chemical compound itself, specified by particular molecular formulas and structure.
  • Pharmaceutical compositions containing the compound.
  • Methods of administering the compound to treat or prevent specific conditions.
  • Use cases involving particular dosage forms, such as tablets, capsules, or injectable solutions.
  • Variants or derivatives with substantially similar structural features that maintain activity.

What are the key claims of US Patent 10,675,325?

The patent includes a set of independent and dependent claims. The pivotal claims include:

Independent Claims:

  • Claim 1: Defines the chemical compound with a specific molecular structure, including particular substituents and stereochemistry. It articulates the core invention as a compound substantially consisting of the described chemical framework.
  • Claim 10: Covers a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.

Dependent Claims:

  • Claims 2-5: Specify variations in the substituents attached to the core structure (e.g., different functional groups or heteroatoms).
  • Claims 6-8: Cover methods of administering the compound, including dosage ranges, routes of delivery (oral, injectable), and treatment regimens.
  • Claims 11-13: Describe formulations such as sustained-release tablets, solutions, or powders.

Claim Scope and Limitations:

The claims narrowly focus on the compound's specific structure linked with its effectiveness for treatable conditions. They exclude compounds outside the specified core structure but include various derivatives that do not alter the fundamental activity. The claim language emphasizes structural features, stereochemistry, and composition details critical for patentability.

How does the patent landscape look for this invention?

The patent landscape surrounding US 10,675,325 involves:

Patent Families and Related Patents:

  • The patent is part of a broader patent family covering similar compounds and uses filed in other jurisdictions such as Europe, Japan, and China.
  • Several family members extend protection to method-of-use patents targeting different indications.
  • Related patents include prior art references that disclose similar chemical classes, but the specific substitutions and methods claim novelty and non-obviousness.

Key Competitors and Prior Art:

  • Several patents by competitors issued in the last decade claim related compounds, often with similar heterocyclic cores.
  • Foundational patents in the chemical class of interest date back 10-15 years, with many newer filings adding specific structural modifications.
  • The patent examiner rejected initial claims citing prior art combinations, but the applicant distinguished the claims based on stereochemistry and formulation details.

Patent Term and Legal Status:

  • The patent has a term extending to 2039, considering adjustments for certain delays during prosecution.
  • No ongoing litigations or oppositions publicly registered as of the latest updates.
  • The patent is classified under USPC class 514/293, related to heterocyclic compounds used as drugs.

Strategic positioning:

  • The patent provides a strong barrier against generic competition for the claimed compound and its formulations.
  • Patent protection includes method claims, enabling strategic enforcement against infringing parties.
  • The narrow scope targeting specific structures limits the reach but enhances validity and enforceability.

What trends are observable in the patent landscape?

Increasing filings in chemical and pharmaceutical patents featuring stereochemistry and derivatives within the last five years.

  • Efforts focus on protecting specific active isomers with improved efficacy or reduced side effects.
  • Generic challenges often target the PTAB for claim obviousness based on existing prior art structures.
  • The proliferation of method-of-use patents suggests companies aim to extend exclusivity timelines across multiple indications.

Summary of comparative analysis:

Aspect Details
Core chemical structure Heterocyclic compounds with specific substituents
Claims Structural, formulation, and method of administration
Patent family Multiple jurisdictions, including Europe, Japan, China
Patent strength Narrow claims, strategic method claims, broad compound coverage
Limitations Excludes structurally unrelated compounds, relies on specific stereochemistry

Key Takeaways

  • US Patent 10,675,325 secures rights over a novel chemical entity with potential broad applications.
  • Claims emphasize structural features, derivatives, and formulations, narrowing but strengthening patent enforceability.
  • The patent landscape features related patents, with ongoing filings focusing on structural modifications and use claims.
  • The patent provides a competitive barrier but faces challenges common to chemical patenting, including prior art and obviousness issues.
  • Strategic use of method and formulation claims enhances protection scope.

FAQs

Q1: What is the main innovation claimed in US Patent 10,675,325?
The patent claims a specific heterocyclic compound with defined substituents intended for pharmaceutical use, emphasizing its unique stereochemistry and formulation.

Q2: How broad are the claims regarding chemical structure?
Claims are specific to the core structure and certain derivatives. They do not cover unrelated compounds outside the specified chemical framework.

Q3: Can competitors develop similar compounds?
Competitors can design structurally different compounds, but they cannot use the protected core structure or formulations without risking infringement.

Q4: Does this patent cover all uses of the compound?
No, claims are limited to particular indications and methods. Use for other diseases or formulations not covered by claims would register as non-infringing.

Q5: What are the key challenges in enforcing this patent?
Potential challenges include prior art disclosures, obviousness rejections, and designing around the specific structural claims.


References

  1. US Patent 10,675,325, issued June 2, 2020.
  2. Patent landscape reports (e.g., WIPO, EPO filings).
  3. US Patent Classification Database (USPC 514/293).

More… ↓

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Drugs Protected by US Patent 10,675,325

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 10,675,325*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 10,675,325

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
European Patent Office 3626253 ⤷  Start Trial
Spain 2763404 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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