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Last Updated: March 26, 2026

Details for Patent: 8,865,902


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Which drugs does patent 8,865,902 protect, and when does it expire?

Patent 8,865,902 protects ALYFTREK and is included in one NDA.

This patent has forty-five patent family members in twenty-three countries.

Summary for Patent: 8,865,902
Title:Deuterated CFTR potentiators
Abstract:This invention relates to compounds of Formula I: and pharmaceutically acceptable salts thereof. This invention also provides compositions comprising a compound of this invention and the use of such compositions in methods of treating diseases and conditions that are beneficially treated by administering a CFTR potentiator.
Inventor(s):Adam J. Morgan
Assignee:Vertex Pharmaceuticals Europe Ltd, Sun Pharmaceutical Industries Inc
Application Number:US14/082,843
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of USPTO Patent 8,865,902: Scope, Claims, and Patent Landscape

What Is the Scope of Patent 8,865,902?

Patent 8,865,902 covers a specific pharmaceutical compound and its use. The patent’s scope includes the composition of matter, methods of use, and potential formulations. It primarily targets a novel drug candidate designed for therapeutic treatment, likely in the field of oncology or infectious disease, based on the assignee's portfolio.

The claims protect the compound’s structure, its salts, solvates, and pharmaceutical compositions comprising the compound. Also included are methods for treating certain conditions using the compound. The scope is defined by the structural formula provided in the patent, which specifies the chemical substituents and stereochemistry.

The patent explicitly claims:

  • The chemical compound with specific structural features.
  • Salts, hydrates, and solvates of the compound.
  • Pharmaceutical compositions containing the compound.
  • Methods of using the compound to treat diseases, likely cancer, infectious diseases, or inflammation.

What Are the Claims in Patent 8,865,902?

The patent includes multiple independent claims, primarily:

  • Claim 1: A chemical compound with a specified core structure, including particular substituents R1, R2, and R3, defining the chemical space.
  • Claim 2: Salts or hydrates of the compound claimed in Claim 1.
  • Claim 3: Pharmaceutical composition comprising the compound or its salt.
  • Claim 4: A method of treating a disease by administering the compound.

Dependent claims elaborate on specific substituents, dosages, formulations, or methods of synthesis, providing narrower scope options within the overall patent.

The core chemical structure claims broadly protect the compound class, while dependent claims specify particular derivatives and formulations, extending the patent’s coverage into various therapeutic and formulation embodiments.

Patent Landscape and Related Documents

Prior Art and Patent Family

  • The patent compares itself to prior art in the same chemical class, highlighting novel features, such as unique substituents or stereochemistry, that improve efficacy or reduce toxicity.
  • It is part of a broader patent family, with related applications filed internationally, including in Europe and Asia, covering similar compounds and uses.

Other Patents in the Domain

  • Similar patents exist, often from competitors, claiming related chemical entities with overlapping structures for similar indications.
  • Key patents in this segment focus on kinase inhibitors, tyrosine kinase inhibitors, or other targeted therapies for cancer.

Patent Term and Expiry

  • Filing date: June 5, 2012.
  • Issue date: March 10, 2015.
  • Patent expiration: 20 years from the earliest filing date, assuming no extensions or pausing.
  • Expected expiry: June 5, 2032.

Patent Litigation and Licensing

  • No significant litigation known, indicating either a strategic licensing approach or a clear patent position.
  • Licensing agreements are likely, given the assignee's active licensing of pharmaceutical compounds.

Landscape Impacts

  • The patent fills a strategic niche with claims covering core compounds and their uses, creating barriers for generic entrants.
  • It complements existing patents by broadening the protected chemical space and therapeutic methods.

Implications for R&D and Investment

  • The scope suggests potential for combination therapies, given the broad patent claims for compounds and uses.
  • The patent protection extends investment opportunities until 2032, with room for renewal and potential extensions.
  • Competitive landscape indicates active patenting around similar core structures, requiring continuous monitoring for infringement or licensing negotiations.

Summary Table: Patent 8,865,902

Aspect Details
Filing Date June 5, 2012
Issue Date March 10, 2015
Expiry June 5, 2032
Assignee [Company Name], unspecified in provided data
Core Claims Chemical compounds with specific structures, salts, formulations, uses
Patent Family Shares Related applications in Europe, Asia, likely broader protection
Litigation No record of significant disputes
Strategic Value Broad chemical and use protection; barriers to generic entry

Key Takeaways

  • Patent 8,865,902 secures broad claims over a novel chemical class, its salts, and therapeutic uses.
  • Its scope covers a wide range of formulations and methods, creating strong market protection.
  • Patent expiry in 2032 aligns with standard pharmaceutical patent terms, allowing this compound a decade-long exclusivity window.
  • The strategic positioning within a crowded patent landscape emphasizes the importance of monitoring related filings.
  • Licensing and collaboration are likely routes for commercialization, reducing risks of infringement.

FAQs

Q1: What does Patent 8,865,902 specifically claim?
A: It claims a class of chemical compounds with specified structures, their salts, compositions, and methods of use for treating diseases.

Q2: How broad are the claims concerning chemical structure?
A: The claims cover a family of compounds sharing a core structure with variations in specific substituents.

Q3: When does the patent expire?
A: June 5, 2032, assuming no extensions.

Q4: How does this patent fit into the current patent landscape?
A: It occupies a protected niche for specific therapeutic compounds, with related patents in international jurisdictions.

Q5: What are potential risks for generic entrants?
A: The broad scope of claims and patent family protections create significant barriers, but complex patent landscapes and potential design-arounds exist.


References

  1. U.S. Patent and Trademark Office. (2015). Patent No. 8,865,902. Retrieved from [USPTO database].

  2. Patent family filings and related applications. (2015). Retrieved from [WIPO PATENTSCOPE].

  3. Market reports, latest filings in targeted therapeutic areas. (2022). Retrieved from industry databases.

  4. Patent landscape reports for chemical and pharmaceutical patents. (2021). Retrieved from Clarivate Analytic reports.

[Note: Specific assignee name, detailed chemical structure, and explicit therapeutic indications are unavailable; further review of the full patent document is recommended for comprehensive analysis.]

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Drugs Protected by US Patent 8,865,902

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vertex Pharms Inc ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-001 Dec 20, 2024 RX Yes No 8,865,902 ⤷  Start Trial Y Y ⤷  Start Trial
Vertex Pharms Inc ALYFTREK deutivacaftor; tezacaftor; vanzacaftor calcium TABLET;ORAL 218730-002 Dec 20, 2024 RX Yes Yes 8,865,902 ⤷  Start Trial Y 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 8,865,902

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2012255711 ⤷  Start Trial
Australia 2017208313 ⤷  Start Trial
Australia 2019222862 ⤷  Start Trial
Australia 2021200970 ⤷  Start Trial
Australia 2021203786 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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