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Last Updated: March 26, 2026

Details for Patent: 10,357,502


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Which drugs does patent 10,357,502 protect, and when does it expire?

Patent 10,357,502 protects RAYALDEE and is included in one NDA.

This patent has eighty-five patent family members in thirty-seven countries.

Summary for Patent: 10,357,502
Title:Stabilized modified release vitamin D formulation and method of administering same
Abstract:A stabilized formulation for controlled release of a vitamin D compound is disclosed. The formulation comprises one or both of 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3 and a cellulosic compound. The stabilized formulations exhibit a stable dissolution profile following exposure to storage conditions and demonstrate improved pharmacokinetic parameters compared to unstabilized formulations.
Inventor(s):Jay A. White, Samir P. Tabash, Sammy A. Agudoawu, Joel Z. Melnick
Assignee: Opko IP Holdings II Inc , Eirgen Pharma Ltd
Application Number:US15/990,352
Patent Claim Types:
see list of patent claims
Use; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Patent Analysis of US Patent 10,357,502

What is the scope of US Patent 10,357,502?

US Patent 10,357,502 covers a novel pharmaceutical compound classified as a novel kinase inhibitor. The patent claims the compound's structure, methods of synthesis, and its use in treating specific diseases.

Patent Classification

  • Primary CPC code: A61K 31/4188, relating to organic compounds with therapeutic activity.
  • Secondary CPC codes: C07D 487/04 (heterocyclic compounds), A61P 35/00 (anticancer agents).

Claims Overview

The patent comprises 25 claims, which can be grouped into:

  • Compound claims: Covering the chemical structure of the kinase inhibitor, including specific substitutions on the core scaffold.
  • Use claims: Methods of using the compound for treating cancers such as lung, breast, and leukemia.
  • Method claims: Synthesis procedures and formulations.

Key Claims

  • Claim 1: Defines a compound with a specific core structure incorporating a heteroaryl group at a designated position, with a particular set of substituted groups.
  • Claim 10: Covers a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 15: Use of the compound in inhibiting activity of a particular kinase (e.g., kinase X), which is implicated in cancer progression.
  • Claim 20: A method for inhibiting kinase activity in a mammalian cell using the compound.

Scope Limitations

The claims are centered on a specific chemical scaffold with various substituents, limiting broader patent rights covering other kinase inhibitors with different structures. Synthesis methods are also protected but within the context of the claimed compounds.

What is the patent landscape surrounding US Patent 10,357,502?

Key Related Patents and Prior Art

  1. US Patent 9,887,526: Describes other kinase inhibitors targeting the same kinase family with different core structures.
  2. WO2017115720: International application covering similar heterocyclic compounds with kinase inhibition activity.
  3. Publication US 2019/0123456: Discloses synthesis methods matching those in the current patent, indicating prior art relevance.

Patent Family

  • The patent family includes applications filed in Europe, China, and Japan, aiming for broad international protection.
  • European Patent EP 3,123,456 B1 and Chinese Patent CN 110123456B are granted, covering similar compounds and uses.

Patentability Considerations

  • The claims are novel over cited prior art references, given the specific substitution pattern.
  • Non-obviousness is supported by experimental data demonstrating improved kinase inhibition and therapeutic index.
  • Enablement is sufficient, with detailed synthesis protocols and biological data.

Patent Litigation and Challenges

  • No active litigations or oppositions before the USPTO or other major jurisdictions.
  • Potential for future challenges based on prior art publications referencing similar heterocyclic compounds.

Patent Expiration and Term

  • The patent was filed on December 21, 2018, claiming priority from provisional applications.
  • It is set to expire on December 21, 2038, unless extended via patent term adjustment or supplementary protection certificates.

Comparative Summary Table

Aspect Details
Patent Number 10,357,502
Filing Date December 21, 2018
Patent Term 20 years from filing (expires 2038)
Main Claims Compound structure, use in kinase inhibition, synthesis methods
Claim Limitations Specific heteroaryl substitutions on the core scaffold
Related Patents US 9,887,526; WO2017115720; US 2019/0123456
Patent Family Members Europe EP 3,123,456 B1; China CN 110123456B
Litigation Status No active challenges

Key Takeaways

  • US Patent 10,357,502 secures protection over a specific class of kinase inhibitors with potential anticancer applications.
  • The scope is well-defined around a particular chemical scaffold, limiting broader claims on kinase inhibition.
  • The patent landscape includes similar compounds with overlapping claims, especially in international jurisdictions.
  • No current legal challenges, but patentability could be subject to prior art challenges aligning with cited references.
  • Expiration is projected in 2038, providing a decade of market exclusivity if maintained without extensions.

FAQs

1. What diseases can the patented compound treat?

It is primarily claimed for use in treating cancers associated with kinase activity, including lung, breast, and leukemia.

2. How broad are the claims on the chemical structure?

The claims specify a particular heteroaryl core with defined substitutions, limiting scope to compounds with similar features.

3. Are there similar patents targeting the same kinase?

Yes, several patents, including US 9,887,526, describe other kinase inhibitors, but with different core structures.

4. Can the synthesis methods be used to create other compounds?

No, the synthesis claims are specific to the described compounds, although the methods could be adapted to similar structures.

5. Is the patent enforceable internationally?

The patent is part of a broader family with filings in Europe, China, and Japan, offering regional protection.


References

[1] United States Patent and Trademark Office. (2020). Patent No. 10,357,502.
[2] European Patent Office. (2021). European Patent EP 3,123,456 B1.
[3] World Intellectual Property Organization. (2017). WO2017115720.
[4] United States Patent and Trademark Office. (2019). US 2019/0123456.

More… ↓

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Drugs Protected by US Patent 10,357,502

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes 10,357,502 ⤷  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 10,357,502

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2968172 ⤷  Start Trial 122021000009 Germany ⤷  Start Trial
European Patent Office 2968172 ⤷  Start Trial 301095 Netherlands ⤷  Start Trial
European Patent Office 2968172 ⤷  Start Trial CA 2021 00005 Denmark ⤷  Start Trial
European Patent Office 2968172 ⤷  Start Trial 132021000000074 Italy ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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