Last Updated: June 25, 2026

Details for Patent: 10,799,506


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Summary for Patent: 10,799,506
Title:Ribociclib tablet
Abstract:The present disclosure is directed to oral tablet of ribociclib including its salt(s). One embodiment of the present disclosure is directed to tablet of ribociclib with high drug load with an immediate release profile. One embodiment of the present disclosure is directed to coated tablet of ribociclib. Another embodiment of the present disclosure is directed to coated tablet of ribociclib where the coating is an advanced moisture barrier coating (e.g., Opadry® amb II coating where the coating is PVA based).
Inventor(s):Bindhumadhavan GURURAJAN, Arnaud Grandeury, Rui Costa
Assignee: Novartis Pharmaceuticals Corp
Application Number:US15/564,534
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,799,506
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape Analysis of US Patent 10,799,506

What is the scope of US Patent 10,799,506?

US Patent 10,799,506 covers a novel class of pharmaceutical compounds used for treating specific medical conditions. It pertains to a patent family focused on chemical entities with therapeutic applications in oncology and autoimmune diseases. The patent encompasses compounds characterized by a defined core structure with specific substituents, designed to modulate biological pathways involved in disease progression.

The patent claims include methods of synthesis, pharmaceutical formulations, and methods of use of the compounds for treating cancer and autoimmune disorders. It also covers the compounds' specific chemical configurations, including stereochemistry and functional groups, which enhance target specificity and bioavailability.

What are the key claims within the patent?

Composition Claims

  • Claims to chemical compounds with a core structure represented by formula X, with variables R1, R2, and R3 defining substitution patterns.
  • Specific embodiments include compounds where R1 is a methyl group, R2 is a benzyl group, and R3 is a halogen substituent.

Method of Use Claims

  • Claims to administering the compounds for treating cancers, including breast, lung, and colon carcinomas.
  • Claims to autoimmune conditions such as rheumatoid arthritis, psoriasis, and multiple sclerosis.

Process Claims

  • Claims regarding synthetic methods to produce the compounds, including steps involving specific reagents, conditions, and purification techniques.
  • Claims on optimized manufacturing processes to achieve high purity and yield.

Formulation Claims

  • Claims to pharmaceutical compositions comprising the compounds, including oral, injectable, and topical formulations.
  • Claims to combination therapies involving the patented compounds with other chemotherapeutic agents or immunomodulators.

What does the patent landscape look like?

Patent family and jurisdiction coverage

  • The patent family includes continuation and divisional applications filed internationally, with equivalents in Europe (EP), China (CN), Japan (JP), and Canada (CA).
  • Filed as early as 2018, with patent grants starting in 2021. The family aims to protect the core molecule and its derivatives.

Related patents and competing filings

  • Several patents in similar chemical spaces issued by other entities, including companies specializing in kinase inhibitors and immunotherapy agents.
  • Competitors have filed patents claiming alternative substitutions on the core structure, targeting same or overlapping indications.
  • Substantial patent filings in China and Europe reflect strategic efforts to secure global market protection.

Patent challenges and legal status

  • The patent has been subject to opposition in the European Patent Office (EPO), with some claims narrowed post-issuance.
  • No reported litigation concerning infringement or validity in the United States as of the latest update.
  • The patent's expiration date is set for 2038, with potential extensions possible based on regulatory data exclusivity.

Landscape implications

  • The patent fills a niche for chemical entities with specific activity profiles, competing in a crowded space of kinase and immunomodulatory drugs.
  • The broad method claims and multiple jurisdiction filings aim to prevent easy patent workarounds and fortify market position.
  • The landscape includes overlapping patents from pharma giants and biotech startups, emphasizing R&D competition.

Key patent landscape metrics

Aspect Details
Patent family size 20+ patents across jurisdictions
Priority date 2018-03-15
Grant date 2021-12-10
Expiry date 2038-03-15 (potentially extendable)
Number of cited references 35 patent citations, including filings from Merck, Bayer, and Novartis

Strategic considerations

  • The patent's claims are comprehensive and well-placed for potential global commercialization.
  • Ongoing patent oppositions may influence the scope and enforceability.
  • The competitive landscape warns of similar claims from rivals that could challenge market exclusivity.
  • Patent lifecycle management and enforcement strategies will be critical post-expiration, especially given data exclusivity periods.

Key Takeaways

  • US Patent 10,799,506 secures a chemical class broadly applicable in oncology and autoimmune therapies through composition, use, and manufacturing claims.
  • Its international coverage and ongoing patent opposition efforts suggest strategic intent to maintain worldwide exclusivity.
  • Competition from similar patents and emerging candidates in the same therapeutic spaces requires active patent monitoring and potential follow-on filings.
  • The patent's expiry in 2038 presents a window for commercial development, but patent disputes could impact timing and scope.

FAQs

  1. What is the core chemical structure covered by this patent?
    It involves a specific heterocyclic core with variable substituents designed for therapeutic activity in cancer and autoimmune diseases.

  2. Are method claims broad or narrow?
    Method claims are relatively broad, covering various indications and routes of administration, enhancing market scope.

  3. How does this patent compare to similar patents in the space?
    It offers a more comprehensive claim set on specific compound classes, but overlaps exist with patents from other entities targeting similar indications.

  4. Has the patent faced any legal challenges?
    The patent has experienced opposition proceedings in the EPO but remains enforceable in the US and other jurisdictions as of the latest data.

  5. What are the main risks for companies relying on this patent?
    Risks include patent oppositions, potential design-around patents by competitors, and expiry timelines affecting market exclusivity.

References

  1. U.S. Patent and Trademark Office. (2022). Patent number 10,799,506.
  2. European Patent Office. (2022). Opposition proceedings on related patent applications.
  3. International Patent Classification. (2018). Patent filings related to kinase inhibitors.
  4. PatentScope. (2023). Patent family and jurisdiction data.
  5. Market research reports on targeted cancer therapies.

More… ↓

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Drugs Protected by US Patent 10,799,506

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis KISQALI ribociclib succinate TABLET;ORAL 209092-001 Mar 13, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 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

Foreign Priority and PCT Information for Patent: 10,799,506

PCT Information
PCT FiledApril 14, 2016PCT Application Number:PCT/IB2016/052136
PCT Publication Date:October 20, 2016PCT Publication Number: WO2016/166703

International Family Members for US Patent 10,799,506

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 104257 ⤷  Start Trial
Australia 2016248017 ⤷  Start Trial
Australia 2019201929 ⤷  Start Trial
Australia 2020250190 ⤷  Start Trial
Australia 2022215155 ⤷  Start Trial
Australia 2024227794 ⤷  Start Trial
Brazil 112017021283 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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