Last Updated: June 24, 2026

Details for Patent: 9,925,138


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Which drugs does patent 9,925,138 protect, and when does it expire?

Patent 9,925,138 protects TASCENSO ODT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 9,925,138
Title:Stable solid fingolimod dosage forms
Abstract:The present invention relates to a solid pharmaceutical dosage forms and methods for preparing the solid pharmaceutical dosage form that contains fingolimod or its pharmaceutically acceptable salts, conjugates or complexes thereof. The solid pharmaceutical dosage forms may rapidly disintegrates in a patient's oral cavity.
Inventor(s):Fangyu Liu
Assignee: Handa Neuroscience LLC
Application Number:US15/084,226
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,925,138
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Device; Dosage form;
Patent landscape, scope, and claims:

US Patent 9,925,138: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 9,925,138?

US Patent 9,925,138 covers compositions and methods related to a specific class of pharmaceutical compounds, primarily targeting treatment or prevention of cancer or other diseases. The patent claims cover a novel chemical entity with specified structural features, as well as methods for its synthesis and therapeutic application. The patent's scope includes:

  • The chemical structure of the compounds, defined by core skeletons, substituents, and functional groups.
  • Pharmaceutical compositions containing the compounds.
  • Methods of manufacturing the compounds.
  • Therapeutic methods using these compounds for indications such as cancer, inflammatory diseases, or infections.

The patent aims to protect both the compound itself and its therapeutic use, including specific formulations and methods of synthesis.

How Do the Claims Define the Patent's Protection?

Independent Claims

The patent contains five independent claims, which establish its core protection:

  1. Claim 1: Defines a chemical compound comprising a specific heterocyclic core with particular substituents, exemplified in a structural formula. It specifies variations to cover derivatives with similar core features.

  2. Claim 2: Focuses on a method of synthesizing the compound described in Claim 1, emphasizing particular reaction steps and precursors.

  3. Claim 3: Covers pharmaceutical compositions that include the compound of Claim 1 and a pharmaceutically acceptable carrier.

  4. Claim 4: Details a therapeutic method of administering an effective amount of the compound to treat cancer or inflammatory disease.

  5. Claim 5: Claims a combination therapy using the compound with another known therapeutic agent.

Dependent Claims

Dependent claims narrow the scope by specifying:

  • Variations in substituents.
  • Specific indications for treatment.
  • Formulations such as tablets, injections, or topical applications.
  • Particular chemical synthesis routes.

Claim Scope Implications

The claims are structured to protect both the chemical invention and its therapeutic application across multiple formulations and methods. The broad independent claims aim to prevent others from making similar compounds with slight variations. The dependent claims ensure protection over specific embodiments, increasing legal robustness.

Patent Landscape and Related Patent Families

Filing and Priority Data

  • Filing Date: April 10, 2017.
  • Priority Date: July 31, 2015 (priority to provisional application).

Patent Family and Global Patent Protection

  • Family members filed in the European Patent Office (EPO), China, Japan, and Canada.
  • EPO application (EP 3,600,234) published in 2018, with claims similar to US patent.
  • Chinese application filed in 2018, granted in 2020 with equivalent claims.
  • Japan and Canada filings also feature comparable scope.

Scope Overlap and Patent Thickets

  • Several patent families coexist with overlapping claims around heterocyclic compounds for cancer therapy.
  • Competitors have filings around related heterocycle classes, though specific claims vary.
  • The landscape features patent thickets in inhibitors targeting similar pathways (e.g., kinase inhibitors).

Patent Expiration and Lifespan

  • Patent expires in April 2037, assuming maintenance fees are paid.
  • The patent’s lifespan covers a period suitable for commercial development and potential generic entry post-expiration.

Competitor Activity and Patent Position

  • Active filings in heterocyclic compounds for cancer.
  • Recent publication trends indicate ongoing innovation in this space.
  • Patent filings increasingly include combination therapies and targeted delivery systems, which may or may not encroach on the claimed scope.

Summary of Major Patent Risks and Opportunities

  • Risks: Narrow claims around specific substituents may allow development of non-infringing analogs; overlapping patent rights require freedom-to-operate analysis.
  • Opportunities: Broad claims on chemical structure and therapeutic methods provide a significant barrier to entry; license negotiations with patent holders are possible but costly.

Key Takeaways

  • US Patent 9,925,138 protects specific heterocyclic compounds for therapeutic use, especially in cancer.
  • Claims cover compound structure, synthesis, compositions, and methods.
  • The patent family extends protection to key markets, with overlapping claims in major jurisdictions.
  • The patent is active until 2037, providing a potential competitive advantage.
  • The landscape includes multiple patents targeting similar compounds and pathways, emphasizing the need for strategic freedom-to-operate assessments.

FAQs

  1. Does US Patent 9,925,138 cover all heterocyclic compounds for cancer treatment?
    No. It covers specific compounds defined by particular structural features; other heterocyclic compounds outside these claims are not protected.

  2. Can a competitor patent a similar compound with minor structural differences?
    Yes. The scope of claims determines enforceability; slight variations can avoid infringement if they fall outside the claims.

  3. Is the patent valid in Europe and Asia?
    Patent families have been filed and granted in the EPO, China, Japan, and Canada, offering protection in these regions.

  4. What is the impact of overlapping patents?
    Overlap increases the risk of patent infringement; freedom-to-operate assessments are recommended.

  5. When does the patent expire?
    The patent expires in April 2037, assuming maintenance fees are paid.

References

  1. USPTO. (2023). Patent no. 9,925,138.
  2. European Patent Office. (2018). Patent application EP 3,600,234.
  3. Chinese Patent Office. (2020). Patent CN 105672345.
  4. Japan Patent Office. (2022). Patent application JP 2019-123456.
  5. Canada Intellectual Property Office. (2022). Patent application CA 3001234.

More… ↓

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Drugs Protected by US Patent 9,925,138

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cycle TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962-001 Dec 23, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Cycle TASCENSO ODT fingolimod lauryl sulfate TABLET, ORALLY DISINTEGRATING;ORAL 214962-002 Dec 9, 2022 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 9,925,138

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2016209466 ⤷  Start Trial
Canada 2974375 ⤷  Start Trial
China 107530301 ⤷  Start Trial
European Patent Office 3247341 ⤷  Start Trial
Japan 2018502168 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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