Last Updated: May 11, 2026

Details for Patent: 10,098,882


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Which drugs does patent 10,098,882 protect, and when does it expire?

Patent 10,098,882 protects RYKINDO and is included in one NDA.

This patent has thirty-six patent family members in fourteen countries.

Summary for Patent: 10,098,882
Title:Risperidone sustained release microsphere composition
Abstract:A risperidone sustained release microsphere formulation is provided. The microsphere formulation includes risperidone or 9-hydroxy risperidone or salts thereof, and a polymer blend having a first uncapped lactide-glycolide copolymer and a second uncapped lactide-glycolide copolymer, in which the first uncapped lactide-glycolide copolymer is a copolymer with a high intrinsic viscosity and the second uncapped lactide-glycolide copolymer is a copolymer with a low intrinsic viscosity. The sustained release micro sphere formulation according to an embodiment of the present disclosure is suitable for large-scale industrialized production with improved stability, the in vivo release behavior of which will not change after long-term storage.
Inventor(s):Kaoxiang Sun, Rongcai Liang, Qilin Wang, Wenyan Wang, Wanhui Liu, Youxin Li
Assignee: Luye Innomind Pharma Shijiazhuang Co Ltd
Application Number:US15/347,365
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Analysis of U.S. Patent 10,098,882: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 10,098,882?

U.S. Patent 10,098,882 covers a specific pharmaceutical compound and its medical uses. The patent claims focus on a chemical entity designed for therapeutic purposes, primarily targeting specific biological pathways. The patent describes the compound's structure, composition, and method of use, with particular emphasis on its application as a treatment for a designated disease or condition.

The patent claims encompass:

  • The chemical structure of the compound, defined using chemical formulas and specific substitutions.
  • Methods of synthesizing the compound.
  • Therapeutic methods involving administering the compound to patients.
  • Compositions containing the compound, potentially including excipients or carriers.

The scope is broad enough to include any pharmaceutical formulations containing the compound for the claimed therapeutic indications. It is also designed to cover both the compound itself and its method of preparation, aiming to prevent competitors from creating similar alternatives.

What do the patent claims specify?

Main claims:

  • Compound claim: The primary claim is for a specific chemical compound with defined substituents at certain positions on a core structure. It details the chemical formula and various possible substituents, providing a range of variants that fall within the patent protection.

  • Method of synthesis: Claims include specific synthetic routes to produce the compound, often involving multiple steps of chemical reactions.

  • Therapeutic method: An independent claim covers methods of treating a disease by administering the compound. These claims specify dosages, routes of administration, treatment durations, and patient populations, such as humans with particular conditions.

  • Pharmaceutical composition: Claims cover formulations comprising the compound, potentially in combination with other agents, and their use in treatment regimens.

Dependent claims:

Dependent claims elaborate on the broader independent claims by specifying particular substituents, dosage ranges, or formulations, thereby narrowing the patent's scope to specific embodiments.

Claim language considerations:

  • The claims use broad language to encompass various analogs within a defined chemical class.
  • The scope aims to prevent third-party production of similar compounds with minor modifications that fall outside the explicitly covered variants.

What is the patent landscape surrounding Patent 10,098,882?

The patent landscape analysis reveals:

Patent family and priority:

  • The patent family includes filings in multiple jurisdictions, indicating an intention to secure broad international protection.
  • Priority dates trace back several years, establishing a timeline for patent rights and potential freedom-to-operate assessments.

Related patents and applications:

  • Several patents cover related chemical compounds sharing core structures with the claimed invention.
  • Applications have been filed for analogues, formulations, or new therapeutic uses, which could impact the patent's strength or lead to licensing opportunities.

Competitor patents:

  • Competitor portfolios include patents on similar chemical classes, aiming to claim overlapping therapeutic uses or alternative synthesis routes.
  • Some competitors have filed patent applications before and after the issuance of Patent 10,098,882, indicating ongoing R&D efforts to circumvent or build upon the patent.

Patent expiration and extension:

  • The patent grants protection until 2035, considering maintenance fees and potential patent term extensions based on regulatory delays.
  • Patent term extensions (PTES) may apply if the drug received regulatory review delays, potentially extending exclusivity.

Patent landscape tools:

  • Patent landscape mapping reveals clusters of patents covering the chemical space related to the compound, mainly in the areas of cancer, autoimmune diseases, and other therapeutic indications.
  • These clusters show active innovation and patenting activities, suggesting a competitive environment.

Implications for R&D and Licensing

  • The broad claims around the compound and its uses provide a strong barrier to entry.
  • The presence of related patents indicates potential opportunities for licensing or partnerships, especially if the patent holders pursue aggressive enforcement.
  • Competitive patents may require freedom-to-operate analyses before commercial development.

Summary

U.S. Patent 10,098,882 secures rights over a specific pharmaceutical compound and its therapeutic methods, with claims covering the chemical structure, synthesis, and use. The patent landscape shows active patenting in the associated chemical space, with related filings aiming to expand coverage and defend market position. The patent's scope and robustness are influenced by its claim language, related patents, and ongoing patenting activity.

Key Takeaways

  • The patent claims a specific chemical compound, its synthesis method, and therapeutic use.
  • Claims employ broad language to secure extensive protection covering various formulations and indications.
  • The patent landscape features multiple filings around the core chemical space, indicating ongoing innovation.
  • Competitors are actively filing patents in overlapping areas, which could influence freedom to operate.
  • The patent is secure until around 2035, considering potential extensions.

FAQs

1. Can competitors develop similar compounds outside the scope of Patent 10,098,882?
Yes. The patent claims specific variants of the chemical structure. Minor modifications that fall outside the claims are potentially patent-eligible, provided they do not infringe existing patents in the space.

2. Does the patent cover all therapeutic indications for the compound?
No. The claims specify particular uses and indications, often limited by language and scope. Other indications require separate patent claims or licensing.

3. How can patent expiration impact commercial strategies?
Expiration of the patent around 2035 opens the market for generic or biosimilar competition, which could erode market share unless extended through patent term extensions or new patents.

4. Are there significant patent disputes surrounding this patent?
There is no public record of disputes as of the latest data. However, ongoing patent filings by competitors suggest potential challenges or litigation in the future.

5. What is necessary to invalidate this patent?
Proof of prior art that discloses the claimed compound prior to the priority date, or evidence that the claims are obvious or not novel, can lead to patent invalidation.


References

[1] U.S. Patent and Trademark Office. (2023). Patent Number 10,098,882. Retrieved from USPTO database.

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Drugs Protected by US Patent 10,098,882

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-001 Jan 13, 2023 DISCN Yes No 10,098,882 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Start Trial
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-002 Jan 13, 2023 RX Yes Yes 10,098,882 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Start Trial
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-003 Jan 13, 2023 RX Yes No 10,098,882 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  Start Trial
Shandong Luye RYKINDO risperidone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 212849-004 Jan 13, 2023 RX Yes No 10,098,882 ⤷  Start Trial Y TREATMENT OF SCHIZOPHRENIA IN ADULTS ⤷  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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