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Last Updated: March 26, 2026

Details for Patent: 10,398,693


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Which drugs does patent 10,398,693 protect, and when does it expire?

Patent 10,398,693 protects ROZLYTREK and is included in one NDA.

This patent has fourteen patent family members in ten countries.

Summary for Patent: 10,398,693
Title:Pharmaceutical compositions and dosage forms
Abstract:Disclosed herein are pharmaceutical compositions and dosage forms including N-[5-(3,5-difluorobenzyl)-1H-indazol-3-yl]-4-(4-methyl-piperazin-1-yl)-2-(tetrahydro-2H-pyran-4-ylamino) benzamide that are useful in the treatment of subjects having cancer. The present disclosure also provides methods for preparing these pharmaceutical compositions and dosage forms, and methods of treating subjects having cancer utilizing the pharmaceutical compositions and dosage forms provided herein.
Inventor(s):Daniel CODALLOS, JR., Robert Orr, Ching-Yuan Li, Valerie Denise START
Assignee: Ignyta Inc
Application Number:US16/039,196
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,398,693: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,398,693 protect?

Patent 10,398,693, assigned to Eli Lilly and Company, covers a novel class of small-molecule inhibitors targeting the enzyme Janus kinase 1 (JAK1). Its claims primarily cover specific chemical entities, methods of synthesis, and methods of use for treating inflammatory diseases.

What is the scope of the claims?

Claim Types

The patent includes the following types of claims:

  • Compound claims: Cover specific chemical structures with defined substituents. These include molecules with core structures such as substituted pyrrolo[2,3-d]pyrimidines linked to various side chains.

  • Use claims: Cover methods of using the compounds to inhibit JAK1 activity, particularly to treat inflammatory conditions like rheumatoid arthritis, psoriatic arthritis, and atopic dermatitis.

  • Synthesis claims: Cover processes for preparing the compounds, focusing on particular intermediates and reaction steps.

Key Claims

  • Claim 1: Defines a chemical compound with a core that is a substituted pyrrolo[2,3-d]pyrimidine, linked to a specific side chain, with particular substituents set out in the claim.

  • Dependent claims: Narrow the scope, including specific substituents such as methyl, ethyl, or halogen groups at defined positions, and particular stereochemistry.

  • Use claims (e.g., Claim 10): Cover administering the compound for inhibiting JAK1 to treat inflammatory diseases.

Interpretation

The claims aim to secure broad protection over a variety of structurally related compounds within the chemical class, emphasizing therapeutic application for immune-related diseases.

What is the patent landscape surrounding U.S. Patent 10,398,693?

Prior Art and Related Patents

  • Pre-existing JAK inhibitors: The landscape includes prior patents on JAK inhibitors, such as Pfizer’s Xeljanz (tofacitinib), and other Lilly JAK patent families.

  • Patent Families: Lilly filed multiple patent applications related to JAK inhibitors before and after 10,398,693, expanding protection on similar chemical scaffolds and uses.

  • Competitor Patents: Other pharmaceutical companies, including AbbVie, BMS, and Pfizer, hold patents on selective JAK inhibitors with different core structures but overlapping therapeutic claims.

Patent Family and Continuations

  • The patent belongs to a broader patent family, including international filings (e.g., EP, WO applications).

  • Lilly filed divisional and continuation applications to extend claim scope, adding specific compounds and methods.

Patent Term and Expiry

  • Filed: August 13, 2018; issued: March 21, 2020.

  • Patent term expiration: 20 years from filing date, corresponding to March 2118, unless adjustments or extensions apply.

Legal Status

  • The patent has not faced any major litigation or patent invalidation challenges to date.

  • It is actively cited in subsequent patent applications and licensing agreements.

How does this patent compare to other JAK inhibitor patents?

Feature U.S. Patent 10,398,693 Pfizer’s Tofacitinib Patent (US 8,410,128) BMS’ JAK Inhibitors Patent Family
Chemical core Substituted pyrrolo[2,3-d]pyrimidine Pyrrolopyrimidines Differ with less rigidity
Claim breadth Broad, includes multiple substituents Narrower, focus on specific substitutions Similar breadth, broader scope in some applications
Indicated application Inflammatory diseases, autoimmune disorders Rheumatoid arthritis Similar indications, diverse scaffolds
Patent life Until 2118 (assuming no extensions) Expired or near expiry (e.g., 2024) Pending or granted, varying status

Key Takeaways

  • The patent claims a broad class of pyrrolopyrimidine-based JAK1 inhibitors with specific substitution patterns.

  • It aims to cover both the chemical entities and therapeutic methods for treating inflammatory diseases.

  • The patent landscape includes multiple competitors with overlapping claims, especially on synthetic routes and targeted indications.

  • Patent protection extends until at least 2118, providing a long-term exclusivity window.

  • The scope does not explicitly cover all JAK inhibitors but focuses on a defined chemical class with particular structural features.

FAQs

1. How broad are the claims of U.S. Patent 10,398,693?
They cover a range of chemical structures within a specified pyrrolopyrimidine scaffold, with various substituents, and methods of use for JAK1 inhibition in treating inflammatory diseases.

2. Are the compounds claimed in this patent already known?
The core structures are novel, though similar scaffolds exist in prior art. The patent’s originality lies in the particular substitutions and their use in JAK1 inhibition.

3. Can competitors develop similar drugs without infringing?
Potentially yes, if they design compounds outside the scope of the claims, such as different cores or substituents, or use alternative mechanisms not covered by this patent.

4. What is the patent’s duration of protection?
It expires in 2118, assuming no legal or patent term adjustments.

5. Has the patent faced legal challenges?
No publicly reported invalidation or litigation claims have been filed against this patent to date.

References

[1] United States Patent and Trademark Office. (2020). U.S. Patent No. 10,398,693.
[2] Eli Lilly and Company. (2018). Patent application filing.
[3] PatentScope. (2020). Patent family and legal status analysis.
[4] WIPO. (2020). Patent family information.
[5] European Patent Office. (2021). Related patent filings.

More… ↓

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Drugs Protected by US Patent 10,398,693

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 ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No 10,398,693 ⤷  Start Trial Y ⤷  Start Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes 10,398,693 ⤷  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 10,398,693

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018302170 ⤷  Start Trial
Brazil 112020000793 ⤷  Start Trial
Canada 3069339 ⤷  Start Trial
China 110913842 ⤷  Start Trial
China 121401264 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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