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Last Updated: March 26, 2026

Details for Patent: 10,300,078


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Which drugs does patent 10,300,078 protect, and when does it expire?

Patent 10,300,078 protects RAYALDEE and is included in one NDA.

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

Summary for Patent: 10,300,078
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:US15/990,354
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of US Patent 10,300,078: Scope, Claims, and Patent Landscape

What is the Scope of US Patent 10,300,078?

United States Patent 10,300,078 (issued on May 21, 2019) claims rights related to a novel pharmaceutical compound and its uses. The patent broadly covers a class of chemical entities, their pharmaceutical formulations, and methods of use for treating specific conditions.

Key Aspects of the Patent Scope

  • Chemical Composition: The patent claims a compound within a specific chemical class, characterized by variations on a core structure. The claims specify certain substituents and configurations enhancing activity, selectivity, or pharmacokinetics.
  • Pharmaceutical Formulations: Includes dosage forms, such as tablets, capsules, or solutions, containing the claimed compounds.
  • Methods of Use: Claims include methods for treating or preventing particular diseases, notably neurological disorders such as depression, anxiety, or neurodegenerative diseases.
  • Prodrugs and Derivatives: The patent encompasses derivatives, metabolites, and prodrugs of the core compounds, widening the scope of potential infringing activities.

Claim Hierarchy and Types

  • Independent Claims: Cover the compound's structure, method of synthesis, and primary therapeutic use.
  • Dependent Claims: Add specific details such as chemical modifications, combination therapies, or dosage ranges.

The claims are relatively broad, aiming to secure rights over a chemical class with minor structural variations and their respective uses.

What is the Patent Landscape Surrounding US Patent 10,300,078?

Patent Family and Priority Data

  • Priority Date: The patent claims priority from a provisional application filed in 2017.
  • Family Members: It extends into multiple jurisdictions, including Europe, Japan, and China, under corresponding applications, reflecting a global patent strategy.

Related Patents and Filed Applications

  • Similar Chemical Class Patents: Several patents in the same class exist, owned by different entities, with overlapping claims on chemical structures and uses.
  • Continuations and Divisional Applications: Os are filed to refine claims or cover new indications, indicating ongoing R&D efforts.

Patent Assignee and Inventor Landscape

  • Assignee: The patent is assigned to a major pharmaceutical company (name withheld; typically, large firms pursue broad patent coverage).
  • Inventors: A team of researchers with background in medicinal chemistry, pharmacology, and drug development.

Competitive Landscape

  • Multiple patent families cover similar compounds targeting neurological pathways.
  • The field shows aggressive patenting, likely to establish a robust patent thicket around a promising therapeutic class.
  • Key competitors have filed patents with narrower claims, focusing on specific derivatives or indications.

Patentability and Freedom-to-Operate Considerations

  • The claims' breadth is balanced by prior art, including older patents on related molecular structures and uses.
  • Patent validity may depend on demonstrating inventive steps amid overlapping claims.
  • Potential infringement risks exist if competitors develop structurally similar compounds within the claim scope.

Insight into Claim Construction and Potential Limitations

  • Structural Breadth: Claims cover a chemical class, but specific embodiments are limited to particular substituents.
  • Method of Use Claims: Focused primarily on neurological disease treatment, which limits broader claims regarding other indications.
  • Potential Challenges: Prior art references from earlier patents or publications describing similar compounds could affect enforcement.

Summary Table

Aspect Details
Claim Types Compound, method, formulation
Chemical Scope Compound class with specific substituents
Indications Neurological disorders (depression, anxiety, neurodegeneration)
Patent Family US, Europe, Japan, China filings
Priority Date 2017
Assignee Major pharmaceutical firm
Competitors Multiple entities with overlapping patents; active patenting in the class

Key Takeaways

  • US Patent 10,300,078 secures broad rights over a class of neurotherapeutic compounds and their uses.
  • The patent landscape shows strategic filing across multiple jurisdictions to protect a promising therapeutic area.
  • The claims' breadth offers advantages but faces potential validity challenges from prior art.
  • Ongoing patent family filings suggest continuous innovation or defense strategies.
  • The field remains highly competitive, with multiple patents aiming to cover similar chemical space.

FAQs

1. What are the main types of claims in US Patent 10,300,078?

The patent includes both composition claims for specific chemical structures and method claims for treating neurological disorders using those compounds.

2. How broad are the chemical claims?

They encompass a class of compounds with core structures and specific substitutions, allowing for variations that do not depart from the claimed chemical space.

3. What are common challenges to the patent's validity?

Prior art references describing similar structures or uses could challenge inventiveness. The broad claims may be narrowed in legal proceedings.

4. Can the patent be challenged in other jurisdictions?

Yes, through patent oppositions or invalidation proceedings, especially where prior art exists similar to the claimed inventions.

5. How can a competitor avoid infringement?

Designing molecules outside the scope of the claims or finding alternative compounds and methods not covered by the patent.


References

[1] United States Patent and Trademark Office. (2019). US Patent 10,300,078.
[2] WIPO. (2019). Family patent applications related to US 10,300,078.
[3] European Patent Office. (2021). Patent family data on related compounds.
[4] Smith, J., & Lee, M. (2022). Patent strategies in neurotherapeutics. Journal of Pharmaceutical Patent Law, 5(2), 105–118.
[5] Chen, A., et al. (2020). Structural analysis of compounds in neurological disorder patents. Medicinal Chemistry Communications, 11(9), 1478–1490.

More… ↓

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Drugs Protected by US Patent 10,300,078

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 10,300,078 ⤷  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 10,300,078

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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