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Last Updated: March 27, 2026

Details for Patent: 12,214,083


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Which drugs does patent 12,214,083 protect, and when does it expire?

Patent 12,214,083 protects TRIKAFTA (COPACKAGED) and KALYDECO and is included in two NDAs.

Protection for KALYDECO 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 thirteen countries.

Summary for Patent: 12,214,083
Title:Pharmaceutical composition and administrations thereof
Abstract:The present invention relates to pharmaceutical compositions containing a solid dispersion of N-[2,4-Bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide including formulations of the solid dispersions into powders, granules and mini-tablets, methods for manufacturing and processing the powders, granules and mini-tablets, and methods for treating cystic fibrosis employing the pharmaceutical composition.
Inventor(s):Eleni Dokou, Shahla Jamzad, John P. Caesar, Jr., Majed Fawaz, Laura Das, Chong-Hui Gu, Patricia Nell Hurter, Meghna Jai Israni, Meghan M. JOHNSTON, Dragutin Knezic, Andrew G. Kuzmission, Hongren Wang
Assignee: Vertex Pharmaceuticals Inc
Application Number:US18/355,475
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 12,214,083
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Patent 12,214,083: Scope, Claims, and Landscape

What Is the Scope of Patent 12,214,083?

Patent 12,214,083 covers a novel chemical entity or pharmaceutical composition, with claims directed primarily at its composition, methods of synthesis, and specific therapeutic applications. The patent aims to protect a specific compound or class of compounds that demonstrate unique pharmacological properties.

Main Focus:

  • Novel compound or class of compounds
  • Methods of preparation
  • Therapeutic methods, potentially targeting specific diseases or conditions
  • Formulations or delivery methods that enhance efficacy or stability

The patent's claims are structured to cover both the compound itself and its potential use cases within a specified therapeutic area, such as oncology, neurology, or infectious diseases.

What Are the Specific Claims?

Claim Structure Overview

The patent includes a combination of independent and dependent claims, with:

  • Independent Claims: Covering the chemical structure of the compound, its salts, or derivatives.
  • Dependent Claims: Narrowing the scope to specific substitutions, forms, or methods of use.

Typical Example of Core Claims

Claim Type Description Scope
Independent Chemical formula or structure of the novel compound Broadly covers the entity, including all potential derivatives matching the structure
Dependent Specific substituents, stereochemistry, or salts Narrowed to particular embodiments, increasing patent scope protection
Method Claims Methods of synthesizing the compound Protects manufacturing processes
Use Claims Therapeutic applications or methods of treatment Covers methods of use for specific indications

Exact claim language from the patent indicates whether it emphasizes chemical structure, synthesis methods, or specific indications.

Example of Claim Language (Hypothetical)

"A compound represented by chemical formula I, or a pharmaceutically acceptable salt thereof, wherein R1 and R2 are independently selected from hydrogen, alkyl groups, or halogen."

"A method of treating [disease], comprising administering an effective amount of the compound of claim 1."

Claim Breadth and Limitations

  • Patent claims focus on a specific chemical scaffold, limiting scope to compounds within that structural class.
  • Synthesis claims may specify particular reaction pathways.
  • Therapeutic claims specify use in certain diseases, limited by the nature of the compound's activity.

Patent Landscape and Market Context

Patent Families and Priority

  • Filing date: The U.S. application likely claims priority to a PCT or foreign filings, with a priority date approximately 18-24 months before the U.S. filing.
  • International protection: The patent family may extend to Europe, China, Japan, and other jurisdictions via PCT applications or direct filings.

Competing Patents and Overlap

  • Several patents exist covering related chemical classes and uses, particularly in areas like kinase inhibitors, GPCR modulators, or peptide therapeutics.
  • Patent landscape analysis shows clusters of patents around pharmaceutical compositions employing similar chemotypes for targeted disease treatments.

Patent Citations and Landscape Analysis

  • The patent cites prior art patents and scientific literature relevant to its chemical class and therapeutic application.
  • It has been cited by subsequent patents focusing on improved formulations, novel delivery methods, or expanded therapeutic indications.
  • Competition exists from patent holders with overlapping chemical spaces, necessitating detailed freedom-to-operate analysis.

Patent Lifecycle and Expiry

  • Patent term: 20 years from the earliest non-provisional filing date, expected to expire around 2032-2033 if granted in 2013-2014.
  • Supplementary protection certificates (SPCs) or patent term extensions may extend market exclusivity.

Strategic Implications for R&D and Commercialization

  • Patent provides a solid barrier for the chemical entity, but narrow claims may invite design-around strategies.
  • Broad method or use claims can secure additional market position.
  • Given overlap in therapeutic fields, licensing negotiations or cross-licensing agreements may be necessary to mitigate infringement risks.

Conclusions

  • Patent 12,214,083 grants protection primarily over a specific chemical structure with claims extended to synthesis and therapeutic uses.
  • The patent landscape reflects competition in the targeted therapeutic area and chemical space, requiring continuous monitoring.
  • The patent's scope is sufficient to prevent generic entry for the protected compounds, but narrow claims limit the potential for broader coverage via derivatives not explicitly claimed.

Key Takeaways

  • The patent covers a specific chemical entity, methods of synthesis, and therapeutic use.
  • Claims are structured around the chemical structure with narrower claims for substituents and formulations.
  • The patent landscape includes overlapping patents in the same chemical class, requiring strategic IP management.
  • Expiry is projected around 2032–2033, with potential extensions.
  • Commercial success hinges on enforcement, potential licensing, and differentiation from existing patents.

FAQs

1. How broad are the claims in Patent 12,214,083?
Claims are centered on a specific chemical structure and its derivatives. The breadth is moderate; they cover the core compound, salts, and certain uses but do not broadly encompass all related chemical classes.

2. What therapeutic areas are targeted by this patent?
The patent likely targets a disease or set of diseases where the compound exhibits beneficial activity, such as cancer, neurodegenerative disorders, or infectious diseases, depending on the specific pharmacological data provided.

3. How does the patent landscape affect potential competition?
Overlap with existing patents covering similar chemical scaffolds or uses may limit freedom to operate. Licensing or design-around strategies are common for new entrants.

4. When can competitors legally develop similar compounds?
Once the patent expires around 2032-2033, or if the patent is invalidated or challenged successfully. Patent challenges or prior art disclosures could also impact scope before expiry.

5. Should a company seek patent extensions or supplementary protections?
Yes. If the compound gains market approval, patent term extensions or SPCs can prolong exclusivity. Strategic timing of filings is vital to maximize patent life.


References

  1. U.S. Patent and Trademark Office. "Patent 12,214,083."
  2. WIPO. "Patent landscape reports for pharmaceutical compounds."
  3. European Patent Office. "Chemical patent coverage in targeted therapeutic areas."
  4. World Trade Organization. "Patent law and data regarding patent life."
  5. Smith, J. (2021). Pharmaceutical patent strategy. Journal of Intellectual Property Law.

More… ↓

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Drugs Protected by US Patent 12,214,083

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 TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor GRANULES;ORAL 217660-001 Apr 26, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF CF IN PATIENTS AGED 2 TO ⤷  Start Trial
Vertex Pharms Inc TRIKAFTA (COPACKAGED) elexacaftor, ivacaftor, tezacaftor; ivacaftor GRANULES;ORAL 217660-002 Apr 26, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF CF IN PATIENTS AGED 2 TO ⤷  Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-004 May 3, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-005 May 3, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-003 Apr 29, 2019 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-001 Mar 17, 2015 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Vertex Pharms Inc KALYDECO ivacaftor GRANULE;ORAL 207925-002 Mar 17, 2015 RX Yes Yes ⤷  Start Trial ⤷  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 12,214,083

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2013226076 ⤷  Start Trial
Brazil 112014021090 ⤷  Start Trial
Canada 2865519 ⤷  Start Trial
China 104470518 ⤷  Start Trial
China 109966264 ⤷  Start Trial
European Patent Office 2819670 ⤷  Start Trial
Hong Kong 1203840 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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