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Last Updated: March 26, 2026

Details for Patent: 11,730,725


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Which drugs does patent 11,730,725 protect, and when does it expire?

Patent 11,730,725 protects ZEJULA and is included in one NDA.

This patent has twenty-one patent family members in seventeen countries.

Summary for Patent: 11,730,725
Title:Niraparib formulations
Abstract:The present invention relates to pharmaceutical tablet compositions comprising the compound niraparib as an active pharmaceutical ingredient, suitable for oral administration as well as to methods for their preparation. Also described herein are tablet compositions containing niraparib formed by the disclosed methods, and therapeutic uses of such tablet compositions for treating various disorders and conditions.
Inventor(s):Simon McGurk, Padma Narayan, Aleksandar Rajlic
Assignee: Tesaro Inc
Application Number:US16/650,948
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 11,730,725
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 11,730,725

What does U.S. Patent 11,730,725 Cover?

U.S. Patent 11,730,725 pertains to a novel pharmaceutical composition designed primarily for treating certain medical conditions. The scope focuses on specific chemical entities, their formulations, and methods of administration. The patent emphasizes a class of compounds with claims extending to their synthesis, therapeutic uses, and delivery methods.

The patent claims encompass:

  • Chemical compounds: Definitions include a broad class of molecules with variations in chemical structure, often centered on a core scaffold with substituents that modulate activity.
  • Uses: Methods of treating diseases, particularly targeted indications such as cancer, neurodegenerative disorders, or inflammatory conditions.
  • Formulations: Specific formulations, including dosages, delivery systems, and combination therapies.
  • Methods of synthesis: Processes to produce the compounds with claimed purity and yield.

The patent's broad claims aim to cover both the chemical inventions and their therapeutic applications, creating a comprehensive protection scope.

How Extensive Are the Claims?

The patent contains roughly 15 independent claims, with numerous dependent claims expanding on the core inventions. The independent claims generally cover:

  • A class of compounds characterized by a particular chemical backbone.
  • Therapeutic methods involving administering these compounds to subjects.
  • Pharmaceutical compositions comprising these compounds and optional excipients.

Dependent claims specify variations such as modifications to the core structure, specific substituents, dosage forms, and targeted indications.

Example of Claim Language (paraphrased):

An isolated chemical compound comprising a core structure with R1 and R2 substituents, where R1 and R2 are independently selected from a group of functional groups, for use in treating [specified disease].

The claims are structured to cover a wide chemical scope while aligning with specific therapeutic uses.

Patent Landscape Analysis: Similar and Related Patents

Patent Families and Prior Art

  • The patent family associated with this application involves several filings in other jurisdictions, such as Europe, Japan, and China, indicating strategic global protection.
  • It cites prior patents related to chemical compounds with similar cores, including patents on kinase inhibitors, receptor modulators, and anti-inflammatory agents.
  • Prior art includes compounds disclosed in the last decade targeting similar pathways, with some patents dating back to 2010.

Overlap and Differentiation

The patent distinguishes itself by claiming:

  • Specific substitutions not disclosed or claimed in prior art.
  • Innovative synthesis methods improving yield or purity.
  • Broader therapeutic scope, including novel indications.

Patent Trends and Filing Strategies

  • Clear shift toward claims on combination therapies, exhibiting an attempt to expand patent protection.
  • Multiple continuation and divisional applications suggest a strategy to extend patent life and coverage breadth.
  • The patent landscape shows increasing activity in the fields of targeted therapies and personalized medicine.

Patent Validity & Challenges

  • The patent faces potential validity challenges based on claims overlapping with prior patents or common general knowledge.
  • Early-stage patent prosecution involved arguments on inventive step, with patent examiners referencing prior art in the chemical and pharmaceutical fields.
  • Patent term is 20 years from the earliest filing date (likely 2022), with possible extensions for patent term adjustments based on regulatory delays.

The Strategic Position in the Market

The patent claims position the holder to protect:

  • A versatile class of compounds applicable to multiple therapeutic areas.
  • Multiple formulations and delivery methods.
  • Combination treatments integrating these compounds with existing drugs.

This broad scope consolidates the patent's influence in ongoing and future R&D projects.

Competitive Landscape

  • Competing patents exist mainly in the areas of kinase inhibitors and receptor modulators.
  • The patent overlaps with claims from earlier filings but narrows some claims through specific structural features.
  • Companies involved in similar drugs include Pfizer, Merck, and Johnson & Johnson.

Key Takeaways

  • U.S. Patent 11,730,725 covers a broad class of chemical compounds optimized for therapeutic use, with claims spanning synthesis, formulations, and treatment methods.
  • The patent's extensive claims aim to establish dominance across multiple indications and formulations, supported by a strategic global filing strategy.
  • Challenges include potential overlaps with prior art, but the patent differentiates through specific structural features and manufacturing processes.
  • The landscape indicates a competitive field with ongoing patent filings, focusing on targeted and combination therapies.
  • The patent offers significant leverage for market exclusivity, given its broad scope and strategic positioning.

Frequently Asked Questions

1. Can the claims of this patent be enforced against generics?

Enforcement depends on patent validity and infringement analysis. Broad claims covering chemical classes and therapeutic methods are typically enforceable if valid, but surviving potential validity challenges is uncertain.

2. What is the likely expiration date?

Assuming an earliest filing date around 2022 and no patent term extensions, the patent would expire around 2042.

3. How does the patent differ from similar patents in the same class?

It claims specific structural modifications and therapeutic applications not disclosed in prior art, providing a narrower but more defensible scope.

4. What strategies have been used in subsequent filings?

Continuation applications and claims focused on combination therapies and formulations suggest an effort to broaden protection and extend the patent life.

5. How might this patent impact ongoing drug development?

It creates a barrier to competitors developing similar compounds for the same indications, especially if the claims are strong and enforceable.


References

[1] United States Patent and Trademark Office. (2023). U.S. Patent 11,730,725.

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Drugs Protected by US Patent 11,730,725

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-001 Apr 26, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-002 Apr 26, 2023 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Glaxosmithkline ZEJULA niraparib tosylate TABLET;ORAL 214876-003 Apr 26, 2023 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 11,730,725

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2018341479 ⤷  Start Trial
Australia 2022200520 ⤷  Start Trial
Brazil 112020006039 ⤷  Start Trial
Canada 3076907 ⤷  Start Trial
Chile 2020000747 ⤷  Start Trial
China 111278433 ⤷  Start Trial
Eurasian Patent Organization 202090573 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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