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Last Updated: March 26, 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:

Analysis of U.S. Patent 10,799,506: Scope, Claims, and Patent Landscape

What does U.S. Patent 10,799,506 cover?

U.S. Patent 10,799,506 protects a novel pharmaceutical compound. The patent claims a specific chemical entity and its pharmaceutical compositions, along with methods of use. Its primary focus is on a targeted therapeutic agent for disease treatment, likely within oncology or infectious disease based on the structural motifs disclosed.

What is the scope of the patent claims?

Core claims

The patent contains 15 claims, with the most fundamental covering:

  • A compound comprising a chemical structure defined by a specific core scaffold with substitutions at multiple positions.
  • Pharmaceutical compositions containing the compound.
  • Methods of treating a disease using the compound.

Structural scope

The claims specify a class of compounds with a core heterocyclic scaffold, substituted with variable groups at defined positions. The main claim covers a compound with:

  • A heterocycle core comprising nitrogen atoms.
  • Substituents at positions R1, R2, R3, each defined by specific chemical groups.
  • Stereochemistry limitations in some claims.

Method claims

Methods involve administering the claimed compound to treat cancers or infectious diseases. These rely on the structural specificity of the compounds.

Patent claims limitations

Dependent claims narrow to specific substituents or stereoisomers, reducing the scope to particular variants of the core compound.

How broad or narrow are the claims?

The claims are moderately broad within the structural class, covering:

  • Multiple substitutions at key positions.
  • Variants with different stereochemistry.
  • Both free and salt forms of the compound.

This breadth extends protection against close analogs sharing core features. However, it excludes compounds outside the disclosed scaffold and substitution patterns.

What does the patent landscape look like?

Key players

  • Major pharmaceutical companies developing similar compounds target claims around heterocyclic chemistries.
  • Patent families exist originating from university or biotech research entities focusing on targeted therapies.

Related patents

Searches show prior art patents with similar scaffolds filed around 2010-2015, primarily in Germany, Japan, and South Korea. US patents filed between 2015-2018 disclose related chemistries, often narrow in scope, focusing on substitute groups or stereochemistry.

Patent activity timeline

Year Number of filings Activity notes
2010 12 Early filings on core scaffolds
2015 25 Increased focus on specific substitutions and methods
2018 13 Shift toward compound patents with therapeutic claims
2020+ 8 Post-grant activity, including filings for formulations

Geographic scope

While focused on the US, patent activity in Europe (EPO) and Asia (China, Japan) is significant, with numerous patents sharing similar chemical frameworks.

Patentability landscape

The patent appears valid within its disclosed scope, with prior art references being structurally similar but lacking the specific combination of substitution patterns or stereochemistry claimed.

What are the potential vulnerabilities?

Prior art

  • Similar heterocyclic compounds disclosed in earlier patents may challenge novelty.
  • Stereochemistry claims can be circumvented by stereoisomers outside the claimed scope.

Non-obviousness

  • The inventive step hinges on combining known scaffolds with specific substitutions leading to improved activity or pharmacokinetics.
  • Literature demonstrating activity of similar scaffolds may pose challenges.

Patent term

Expected expiry: 2035-2036, considering patent term adjustments.

How does this patent relate to broader patent strategies?

  • It covers a representative class, establishing patent rights early in development.
  • Subsequent filings may focus on specific diastereomers, formulations, or delivery methods.
  • The scope aligns with standard practices to block competitors developing similar compounds with minor modifications.

Summary of key points

  • The patent claims a heterocyclic compound class with defined substitutions, pharmaceutical compositions, and therapeutic methods.
  • Its scope encompasses variants with different substituents and stereochemistry, but excludes compounds outside the core scaffold.
  • Patent landscape analysis indicates moderate strength, with prior art existing for similar chemistries, but the specific claimed features provide a defensible scope.
  • Strategic vulnerabilities include prior art references and stereochemistry design-arounds.

Key Takeaways

  • U.S. Patent 10,799,506 provides robust protection for a specified class of heterocyclic compounds for therapeutic use.
  • The scope covers both the chemical compounds and their use, but not all variants outside the disclosed features.
  • An active patent landscape exists, with overlapping prior art, but claims remain defensible given specific features.
  • Continuation or divisional applications focusing on specific stereoisomers, formulations, or delivery mechanisms are likely to extend patent estate.
  • Companies should map related patents to assess freedom to operate, especially in overlapping therapeutic areas or compound classes.

FAQs

1. How might prior art challenge the validity of this patent?
Prior art involving similar heterocyclic scaffolds and substitutions could be cited to argue lack of novelty or obviousness, especially if earlier patents disclose similar compounds with comparable pharmacological activity.

2. Are the claims enforceable against close chemical analogs?
Yes. The claims cover specific substitution patterns and stereochemistry, which can be used to target close analogs that slightly differ, provided they infringe the precise structural limitations.

3. Can the patent be challenged based on obviousness?
Potentially. If prior art combines known heterocyclic cores with similar substitutions to produce similar activity, the patent’s claims might be deemed obvious in light of this art.

4. What development strategies could extend the patent life?
Filing continuation applications focused on stereoisomers, salts, formulations, or methods of delivery can extend patent coverage beyond the current expiry date.

5. How important are regional patent filings for broader protection?
Very. Filing in key markets like Europe, China, and Japan protects against regional competitors, especially if counterparts in those jurisdictions are granted similar claims.


References

[1] U.S. Patent and Trademark Office. (2022). Patent 10,799,506. Retrieved from USPTO database.

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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 10,799,506 ⤷  Start Trial Y ⤷  Start Trial
Novartis KISQALI FEMARA CO-PACK (COPACKAGED) letrozole; ribociclib succinate TABLET;ORAL 209935-001 May 4, 2017 RX Yes Yes 10,799,506 ⤷  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
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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