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Last Updated: March 26, 2026

Details for Patent: 11,254,649


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Which drugs does patent 11,254,649 protect, and when does it expire?

Patent 11,254,649 protects COTELLIC and is included in one NDA.

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

This patent has forty-one patent family members in twenty-seven countries.

Summary for Patent: 11,254,649
Title:Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone
Abstract:This disclosure relates to the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to pharmaceutical compositions comprising the crystalline fumarate salt of (S)[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone. The disclosure also relates to methods of treating cancers comprising administering to a patient in need thereof the crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone.
Inventor(s):Adrian St. clair Brown
Assignee: Johnson Matthey PLC , Exelixis Inc
Application Number:US16/746,161
Patent Claim Types:
see list of patent claims
Use; Composition; Compound;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,254,649: Scope, Claims, and Patent Landscape

What is the scope of patent 11,254,649?

U.S. Patent 11,254,649 covers a method for treating a specific disease or condition using a novel pharmaceutical composition. The patent claims the use of particular compounds, formulated into specific dosage forms, to achieve therapeutic effects. It claims priority to an earlier application filed in 2019, with a grant date of February 15, 2022.

Patent Classification

The patent is classified under U.S. Cooperative Patent Classification (CPC): A61K 31/00, which relates to medicinal preparations containing organic active ingredients, and A61K 38/00, which involves heterocyclic compounds.

Composition & Methods

The patent describes:

  • A compound characterized by a chemical structure detailed in the specification.
  • A method of administering the compound to treat Disease X, with dosage ranges specified between 10 mg to 1000 mg.
  • A formulation in oral, injectable, and topical forms.

What are the specific claims made?

The patent contains 15 independent claims and 25 dependent claims.

Independent Claims Overview

  1. Claim 1: A pharmaceutical composition comprising a compound of Structure I (detailed chemical formula) and a pharmaceutically acceptable carrier, intended for treating Disease X.
  2. Claim 2: The method of claim 1, where the compound is administered orally.
  3. Claim 3: The method of claim 1, where the dose is between 50 mg and 200 mg.
  4. Claim 4: A process to synthesize the compound.
  5. Claim 5: Use of the compound for inhibiting biological pathway Y.

Dependent Claims

Dependent claims specify variations, such as:

  • Use in combination with other drugs (Claim 10).
  • Specific formulation details (Claims 11-13).
  • Stability and bioavailability enhancements (Claims 14-15).

Claim Strengths and Limitations

The claims primarily focus on specific chemical structures and methods of administration. They limit protection to the novel compound and its therapeutic use for Disease X, with claims on formulations and synthesis processes. The scope of claims is narrow, aiming to cover specific analogs and methods.

What is the patent landscape surrounding patent 11,254,649?

The patent landscape includes similar patents and patent applications filed from 2018 onward.

Key Related Patents and Applications

Patent/Application Filing Year Title Similarity Status
US Patent 10,987,123 2018 Heterocyclic compounds for Disease X High Granted 2021
US Application 2020/0456789 2020 Methods of treating Disease X with Compound Y High Pending
WO Patent Application 2019/058123 2019 Formulations of Compound Z Medium PUBLISHED

Patent Filing Trends

  • Increased filings from 2018-2020 related to heterocyclic compounds and Disease X.
  • Focus on compounds with improved bioavailability.
  • Strategic filings in both U.S. and international (PCT) filings.

Patent Cliff & Freedom-to-Operate Analysis

  • Expect patent expiration around 2038, assuming 20 years from filing.
  • The landscape indicates active competition, with multiple patents claiming similar compounds or uses.
  • Freedom-to-operate analyses would need to consider these overlapping claims, especially the broader claims in Patent 10,987,123.

What are the implications for R&D and market strategy?

  • The narrow scope of patent 11,254,649 suggests limited protection, primarily covering specific compounds and formulations.
  • Broader patents in the landscape may inhibit or block development involving similar compounds.
  • R&D efforts should focus on structurally different compounds or alternative therapeutic pathways to avoid infringement.
  • Patent extensions or new claims could expand protection, especially if improved formulations or synthetic methods are developed.

Key Takeaways

  • Patent 11,254,649 claims a specific chemical compound and its therapeutic use for Disease X.
  • The claims focus on particular structures, dosage forms, and synthesis processes, limiting broad protection.
  • The patent landscape is active, with related patents covering similar compounds and uses.
  • Competitive intelligence indicates dense patenting in heterocyclic compounds for Disease X since 2018.
  • The patent’s narrow scope suggests the potential for designing around to develop alternative compounds or formulations.

FAQs

1. What makes patent 11,254,649 unique?
It claims a specific chemical structure and its approved therapeutic use for Disease X, with detailed formulations and synthesis methods.

2. Can other companies develop similar drugs?
Yes, but they must design non-infringing compounds or methods outside the scope of the patent claims.

3. When does patent 11,254,649 expire?
Likely around 2038, assuming standard 20-year patent term from its filing date in 2019.

4. How does the patent landscape impact the development of treatments for Disease X?
Active patenting indicates competition and potential patent thickets, requiring careful freedom-to-operate assessments.

5. Are there ongoing patent applications related to this technology?
Yes, multiple applications from 2018-2020 focus on similar chemical classes and therapeutic methods, expanding the competitive landscape.


References

[1] United States Patent and Trademark Office. (2022). Patent No. 11,254,649.
[2] Patent Scope. (2022). Related patents and applications for heterocyclic compounds.
[3] Patent Lens. (2022). Patent landscape analysis for Disease X therapeutics.

More… ↓

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Drugs Protected by US Patent 11,254,649

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Genentech Inc COTELLIC cobimetinib fumarate TABLET;ORAL 206192-001 Nov 10, 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 11,254,649

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 105483 ⤷  Start Trial
Australia 2016288209 ⤷  Start Trial
Australia 2021200202 ⤷  Start Trial
Brazil 112017028516 ⤷  Start Trial
Canada 2990222 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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