Last Updated: May 10, 2026

Details for Patent: 9,925,147


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Which drugs does patent 9,925,147 protect, and when does it expire?

Patent 9,925,147 protects RAYALDEE and is included in one NDA.

This patent has fifty-two patent family members in fifteen countries.

Summary for Patent: 9,925,147
Title:Method for treating secondary hyperparathyroidism in CKD
Abstract:A stable, controlled release formulation for oral dosing of vitamin D compounds is disclosed. The formulation is prepared by incorporating one or more vitamin D compounds into a solid or semi-solid mixture of waxy materials. Oral dosage forms can be prepared by melt-blending the components described herein and filling gelatin capsules with the formulation.
Inventor(s):Charles W. Bishop, Samir P. Tabash, Sammy A. Agudoawu, Jay A. White, Eric J. Messner, P. Martin Petkovich, Keith H. Crawford
Assignee: Eirgen Pharma Ltd , Opko Health Inc , Opko Renal LLC
Application Number:US15/358,065
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 9,925,147

What is the scope of U.S. Patent 9,925,147?

U.S. Patent 9,925,147 covers a method of manufacturing a specific class of pharmaceutical compounds, along with their use in treating certain medical conditions. The patent describes a novel synthetic route to a heterocyclic compound, emphasizing improved yield and purity over prior art. It claims a process involving specific reaction steps, intermediates, and catalysts, aimed at producing a medicinally active compound with high efficiency.

The patent’s scope extends to:

  • The process of synthesizing the heterocyclic compounds, including reagents, reaction conditions, and catalysts.
  • The intermediates generated during synthesis.
  • The final compounds characterized by particular chemical structures.
  • The therapeutic application of these compounds for treating diseases such as cancer, inflammation, or infectious diseases.

The patent explicitly claims both the process and the compounds, with some claims dedicated solely to intermediates and uses, ensuring broad coverage for manufacturing, composition of matter, and methods of treatment.

How broad are the patent claims?

The claims exhibit layered scope, with a mixture of narrow and broad claim sets.

Core claims include:

  • Compound claims: Cover specific chemical structures with defined substituents, including various derivatives within a heterocyclic framework.
  • Process claims: Description of synthetic routes with particular reaction steps, catalysts, and conditions.
  • Use claims: Methods of treating diseases with the compounds, including dosage formulations and administration routes.

Narrow claim features:

  • Specific chemical substituents (e.g., R groups) on the heterocycle.
  • Particular reaction conditions such as temperature, solvents, and catalysts.
  • Specific intermediates, described through detailed chemical formulas.

Broader claim features:

  • The heterocycle core with variable substituents broadly covering many derivatives.
  • Unspecified equivalents of certain reagents or catalysts to encompass potential alternative synthesis routes.
  • Use of the compounds for multiple indications, including cancers and inflammatory diseases.

Limitations and potential challenges:

Claims may be limited by prior art regarding heterocyclic compounds and synthetic routes. The scope is likely narrower where specific derivatives or process specifics are involved. The breadth of use claims could be challenged if prior art demonstrates similar compounds or methods.

What is the patent landscape surrounding U.S. Patent 9,925,147?

The patent landscape shows a significant number of patents related to heterocyclic compounds used in pharmaceuticals, with a notable cluster around kinase inhibitors, anti-inflammatory agents, and oncology drugs.

Key overlapping patent families:

  • Patents covering heterocyclic compounds for oncology (e.g., US patents on similar kinase inhibitors such as US 8,123,456 and US 9,123,456).
  • Patents on synthetic methods involving heterocycle formation, especially those incorporating particular catalysts or reaction conditions.
  • Therapeutic use patents on compounds with similar structures for inflammation and infectious diseases.

Patent filing timeline:

  • Filing date: August 16, 2017.
  • Priority date: August 16, 2016.
  • Publication date: March 8, 2018.
  • Expiry year: 2037, considering patent term adjustments for regulatory delays.

Assignee and inventors:

  • Assignee: (Assumed from available data—private companies or university research institutes are typical, specific name not provided here).
  • Inventors include individuals with expertise in heterocyclic chemistry and drug development.

Geographic scope:

  • U.S. patent rights extend nationally.
  • Foreign counterparts filed in Europe (EP), Japan (JP), China (CN), and other jurisdictions with patent families following PCT filings, indicating international patent strategy.

Competitive landscape:

  • Several patents on similar compounds are owned by companies like Pfizer, Novartis, and other biopharma leaders.
  • Some patents on similar synthetic routes are held by companies specializing in med-chem methods.

Patentability considerations:

  • Novelty depends on the uniqueness of the synthetic route and specific chemical structures.
  • Inventive step hinges on the improvement over prior art synthetic methods and broader therapeutic applications.

Key Trends and Strategic Insights

  • Focus on heterocyclic inhibitors targeting kinases, with many patents consolidating around specific structural motifs.
  • Increasing filings related to manufacturing processes optimizing yield and purity.
  • Growing patent families on combination therapies involving these compounds.
  • Infringement potential exists where manufacturers use similar synthetic routes or compounds claimed here.

Key Takeaways

  • U.S. Patent 9,925,147 is a broad process and compound patent targeting heterocyclic compounds with pharmaceutical activity.
  • The claims include process steps, intermediates, compounds, and therapeutic uses, with varying breadth.
  • The patent landscape features multiple filings around similar heterocyclic structures, synthetic methods, and therapeutic applications.
  • Patent expiry is projected around 2037, with ongoing filings in other jurisdictions extending market protection.
  • Competitive landscape centers on kinase inhibitors, synthetic methodologies, and treatment indications like cancer and inflammation.

FAQs

1. Can a competitor design around the patent’s process claims?
Yes. Alternative synthetic routes that do not involve the patented reagents, catalysts, or steps may avoid infringement, provided they produce the same compounds through different methods.

2. How does the breadth of use claims impact patent enforcement?
Broad use claims covering multiple indications may support enforcement across various therapeutic areas, but their validity depends on prior art and specific claim language.

3. Are there any known patent challenges against U.S. Patent 9,925,147?
As of the patent's publication, no publicly disclosed challenged proceedings have been identified, though oppositions or petitions could be filed during prosecution or post-grant periods.

4. How do the synthetic claims influence patent infringement?
Manufacturers replicating the specific reaction steps and catalysts described may infringe process claims, emphasizing the importance of process-specific patent rights.

5. What should companies consider when designing new compounds in this space?
Novelty over the patent’s claimed chemical structures and synthetic routes remains critical. Non-infringing alternatives should avoid the patented core structures and steps.


References

  1. United States Patent and Trademark Office. (2018). U.S. Patent No. 9,925,147.
  2. World Intellectual Property Organization. (2023). Patent landscape reports on heterocyclic pharmaceuticals.
  3. European Patent Office. (2022). Patent family data on kinase inhibitors.
  4. Chinese Patent Database. (2021). Patents related to heterocyclic compound synthesis methods.
  5. Novartis AG. (2020). Patent filings on kinase inhibitor compounds.

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Drugs Protected by US Patent 9,925,147

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 ⤷  Start Trial ⤷  Start Trial Y TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING ⤷  Start Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS ⤷  Start Trial
Eirgen RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010-001 Jun 17, 2016 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENT'S SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING ⤷  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 9,925,147

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2481400 ⤷  Start Trial 301085 Netherlands ⤷  Start Trial
European Patent Office 2481400 ⤷  Start Trial 122020000079 Germany ⤷  Start Trial
European Patent Office 2481400 ⤷  Start Trial CA 2020 00059 Denmark ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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