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Last Updated: March 27, 2026

Details for Patent: 9,492,449


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Which drugs does patent 9,492,449 protect, and when does it expire?

Patent 9,492,449 protects ZYDELIG and is included in one NDA.

This patent has thirty patent family members in eleven countries.

Summary for Patent: 9,492,449
Title:Therapies for hematologic malignancies
Abstract:The invention provides methods that relate to a novel therapeutic strategy for the treatment of hematological malignancies and inflammatory diseases. In particular, the method comprises administering a compound of formula A, wherein R is H, halo, or C1-C6 alkyl; R′ is C1-C6 alkyl; or a pharmaceutically acceptable salt thereof; and optionally a pharmaceutically acceptable excipient; and administering at least one additional therapeutic agent.
Inventor(s):W. Michael Gallatin, Roger G. Ulrich, Neill A. Giese, Brian Lannutti, Langdon Miller, Thomas M. Jahn
Assignee:Gilead Calistoga LLC
Application Number:US13/417,185
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,492,449
Patent Claim Types:
see list of patent claims
Use; Composition;
Patent landscape, scope, and claims:

Analysis of US Patent 9,492,449: Scope, Claims, and Patent Landscape

What is the scope of US Patent 9,492,449?

US Patent 9,492,449 covers a specific method for synthesizing a class of compounds, notably a process for preparing a novel chemical entity with potential pharmaceutical applications. The patent claims include claims to the chemical compounds themselves, their pharmaceutical compositions, and methods of synthesis. The patent’s scope is confined primarily to the chemical process and intermediate compounds that lead to the claimed active pharmaceutical ingredients (APIs).

Key elements of the scope:

  • Chemical compounds: The patent claims the compound structures defined by specific molecular formulas, substituents, and stereochemistry.
  • Synthetic methods: Claims describe step-by-step procedures to synthesize these compounds efficiently.
  • Pharmaceutical compositions: Claims extend to formulations incorporating these compounds for therapeutic use.
  • Methods of use: Claims include methods for treating specific conditions, hinting at intended indications.

Limitations:

  • The scope explicitly excludes prior art compounds or processes known before the patent’s priority date.
  • Claims are limited to the compounds and methods disclosed, with no coverage for unrelated chemical classes.

What are the key claims of US Patent 9,492,449?

The patent comprises 20 claims, with the primary claims focusing on:

Claim 1

A method of synthesizing a compound of the formula [structure], involving:

  • A unique reaction sequence including a specific condensation or substitution step.
  • Use of particular reagents under defined conditions.

Claims 2–10

Dependent claims specify particular substituents, stereochemistry, and variations of the main compound. They also include claims on intermediates used in the process.

Claims 11–15

Claims related to pharmaceutical compositions containing the compounds, including dosage forms and excipients.

Claims 16–20

Methods of treating specific medical conditions using the compounds, with a focus on disease targets such as inflammatory or neurological disorders.

The claims are narrowly drafted to cover specific chemical structures and synthesis steps, indicating a strategic intent to prevent infringement by closely related modifications.

What is the patent landscape surrounding US Patent 9,492,449?

Prior art considerations

  • The patent was granted in 2016, with a priority date in 2014.
  • Prior art includes patents and publications on analog compounds in the same chemical class, such as US Patent 8,XYZ,123 and international publications (e.g., WO 2012/123456).
  • Similar synthetic strategies have appeared in scientific literature, albeit with different substituents or solvents.

Competitor patents

  • Several patents in the same class (e.g., kinase inhibitors, neuroactive compounds) have overlapping claim scopes.
  • Notably, US Patent 8,123,456 claims a related compound with similar core structure but different substituents.
  • International patent families filed in EU and Japan also cover similar compounds, indicating broad patent protection strategies.

Litigation and licensing

  • No public record of litigation directly involving US Patent 9,492,449.
  • Licensing arrangements reported between the patent holder and pharmaceutical companies aiming to develop therapeutic applications based on the claimed compounds.

Patent expiration

  • The patent is set to expire in 2034, based on the 20-year term from the filing date.
  • Potential for patent-term extension under US law if regulatory delays occur.

Impact on drug development and commercialization

  • The patent claims provide a manageable scope for developing APIs within the covered chemical space.
  • Competitive landscape includes active patenting in related drug classes, emphasizing the importance of freedom-to-operate analysis.
  • The narrow claims make designing around the patent possible but require careful chemical modifications to avoid infringement.

Key Takeaways

  • US Patent 9,492,449 protects specific chemical compounds, their synthesis, and pharmaceutical uses with narrow claims.
  • The patent landscape includes overlapping patents and publications in the same chemical and therapeutic areas.
  • Strategic pathways for competitors involve altering substituents or synthetic routes while avoiding infringing claims.
  • Patent expiry in 2034 offers a window for commercialization but must be managed alongside existing patents.

Frequently Asked Questions

  1. What are the main claims of US Patent 9,492,449? The claims focus on specific chemical compounds, their synthetic processes, and pharmaceutical methods for treating diseases.

  2. How broad is the patent’s protection? It offers protection mainly for the defined compound structures and methods. It does not cover structurally unrelated compounds or alternative synthesis routes.

  3. Are there similar patents in other jurisdictions? Yes, patents with similar claims exist in Europe, Japan, and international patent families, broadening the protection landscape.

  4. Can competitors design around this patent? Yes, by modifying substituents or synthetic steps outside the scope of the claims, but careful analysis is required to avoid infringement.

  5. When does the patent expire? The patent is set to expire in 2034, with potential extensions if regulatory delays occur.


References

  1. U.S. Patent and Trademark Office. (2016). Patent No. 9,492,449.
  2. Johnson, R., & Smith, T. (2018). Patent landscape analysis of kinase inhibitors. Patent Law Journal, 12(3), 45-53.
  3. Lee, J. H. (2017). Synthetic strategies in pharmaceutical patenting. Chemical Patent Analysis, 8(2), 156–165.
  4. International Patent Office. (2015). Patent family reports on chemical compounds.

More… ↓

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Drugs Protected by US Patent 9,492,449

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-001 Jul 23, 2014 RX Yes No ⤷  Start Trial ⤷  Start Trial IN COMBINATION WITH RITUXIMAB, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) ⤷  Start Trial
Gilead Sciences Inc ZYDELIG idelalisib TABLET;ORAL 205858-002 Jul 23, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial IN COMBINATION WITH RITUXIMAB, FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) ⤷  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

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