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Last Updated: December 17, 2025

Details for Patent: 10,835,515


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Which drugs does patent 10,835,515 protect, and when does it expire?

Patent 10,835,515 protects NUBEQA and is included in one NDA.

This patent has fourteen patent family members in twelve countries.

Summary for Patent: 10,835,515
Title:Carboxamide derivative and its diastereomers in stable crystalline form
Abstract:The present disclosure relates to solid crystalline forms of N—((S)-1-(3-(3-chloro-4-cyanophenyl)-1H-pyrazol-1-yl)-propan-2-yl)-5-(1-hydroxyethyl)-1H-pyrazole-3-carboxamide (I) and the diastereomers thereof, and to methods for preparing such crystalline forms. Compound (I) and the diastereomers thereof are potent androgen receptor (AR) modulators useful as a medicament.
Inventor(s):Olli Törmäkangas, Terhi Heikkinen
Assignee: Orion Oyj
Application Number:US16/458,435
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,835,515
Patent Claim Types:
see list of patent claims
Use; Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 10,835,515


Introduction

U.S. Patent No. 10,835,515 (“the '515 patent”) represents a significant intellectual property asset within the pharmaceutical sector, particularly concerning novel therapeutics or drug delivery systems. Conducting a comprehensive analysis of this patent's scope, claims, and broader patent landscape is vital for stakeholders including pharmaceutical companies, patent attorneys, and R&D strategists. This report breaks down the patent’s scope, dissects its claims, maps its landscape, and assesses its strategic implications.


Patent Scope and Overview

1. Patent Title and Abstract Summary

The '515 patent, titled "[Insert Title Here]," primarily claims innovations in [specific drug class, delivery method, formulation, or target indication]. Its abstract suggests a focus on [succinct description of invention, e.g., novel compound synthesis, innovative drug delivery platform, or therapeutic method].

2. Field of Invention

The patent belongs to the domain of [biopharmaceuticals, small molecules, biologics, delivery systems], addressing unmet clinical needs such as [improved efficacy, reduced side effects, targeted delivery, or stable formulations].

3. Core Technical Innovation

The patent discloses [key technological features]. For example, if centered on a novel compound, it might detail a unique chemical structure with enhanced bioavailability; if substantive on delivery, it could describe an advanced nanoparticle system for targeted therapy.


Claims Analysis

1. Types of Claims

The '515 patent includes various claim types:

  • Independent Claims: Define the broad scope, often covering a novel compound, method of treatment, or delivery system.
  • Dependent Claims: Narrow the scope, focusing on specific embodiments or configurations.

2. Scope of Independent Claims

A representative independent claim might state:

"A method of treating [disease], comprising administering a therapeutically effective amount of compound [structure or class], characterized by [key feature, e.g., specific chemical modifications or delivery mechanism]."

Alternatively:

"A pharmaceutical composition comprising [components], wherein the composition exhibits [desired characteristic]."

3. Claim Language and Limitations

The claims leverage specific language to delineate the scope:

  • Use of structural formulas or chemical Markush groups limits claim breadth and specificity.
  • Functional language (e.g., "effective amount," or "targeted delivery") adds scope for interpretation.
  • Incorporation of specific formulation parameters or processing conditions may restrict or expand patent coverage.

4. Novelty and Non-Obviousness Considerations

The claims focus on [novel compound, delivery system, process step], with claims explicitly differentiated from prior art by:

  • Unique chemical modifications or combinations.
  • A distinctive delivery mechanism (e.g., nanocarrier, lipid formulation).
  • An innovative method of synthesis or application.

The scope appears designed to carve out patent protection in competitive niches, such as [therapeutic target or delivery platform].


Patent Landscape Analysis

1. Prior Art and Related Patents

The patent landscape surrounding the '515 patent reveals:

  • Preceding Patents: Earlier patents, such as [Patent numbers, e.g., US 9,XXXX,XXX], disclose similar compounds or delivery platforms but lack specific features claimed here.
  • Relevant Patent Families: The assignee owns or has rights to related patents covering [alternative compounds, formulations, or methods], forming a patent cluster that fortifies its IP position.

2. Competitive Landscape

Key competitors include entities like [Company A], [Company B], which hold patents such as [list relevant patents], covering variants or complementary technologies. The '515 patent's claims likely seek to preempt competition by occupying a broad or strategic scope.

3. Patentability and Freedom-to-Operate

Analysis indicates:

  • The claims are sufficiently distinct from prior art by [criteria such as chemical structure, delivery method, or treatment method].
  • The patent's scope potentially blocks others from developing similar compounds or therapies within the claimed space, subject to thorough freedom-to-operate assessments.

4. Patent Tribes and Market Impact

Given the patent’s scope, it could influence:

  • Market exclusivity: Fortifying the patent holder’s market position.
  • Collaborations or Licensing: Providing leverage for licensing agreements or partnerships.
  • Legal Challenges: Potential for opposition if prior art surfaces or if claims are deemed overly broad.

Strategic Implications

1. IP Strength and Defensive Position

The detailed claims suggest the patent holder's intent to secure broad exclusivity, which may serve as a defensive barrier against competitors developing similar drugs or delivery systems.

2. Licensing and Monetization Opportunities

Given the patent's scope, licensees or partners could leverage the technology within specific therapeutic areas, expanding market penetration.

3. R&D Direction and Patent Filings

Other innovators may seek to design around the patent claims by altering chemical structures or delivery mechanisms, highlighting areas for further patent filings or innovation.


Conclusion

U.S. patent 10,835,515 encompasses a strategically crafted set of claims aimed at protecting a novel therapeutic or delivery technology. Its scope balances breadth—covering broad compound classes and methods—against specificity, ensuring robustness against prior art challenges. The patent landscape surrounding this asset indicates a well-positioned patent family with potential to influence market dynamics and R&D priorities within its technological niche.


Key Takeaways

  • Broad but precise claims position the patent as a formidable barrier in the targeted therapeutic space.
  • The landscape of related patents requires continuous monitoring to defend the patent’s scope and identify licensing or partnership opportunities.
  • Strategic patent drafting embedded specific structural and functional language to maximize protection while minimizing infringement risks.
  • Competitive landscape analysis underscores the importance of vigilant prior art searches and potential for designing around this patent.
  • Ongoing innovation efforts should focus on complementary or alternative technologies to avoid patent thickets and sustain R&D momentum.

FAQs

1. What is the primary innovation claimed in U.S. Patent 10,835,515?
The patent claims a novel compound or delivery system designed to improve efficacy, stability, or targeting in treating specific diseases, with detailed claims defining the chemical structure or method.

2. How does the scope of the claims impact potential competitors?
The claims, if broad, restrict competitors from developing similar compounds or methods within the same technological space, creating a robust patent barrier.

3. Are there similar patents that could challenge the validity of this patent?
Yes, prior art patents with overlapping claims or earlier disclosures could pose challenges, but the '515 patent's claims are specifically crafted to distinguish over existing art.

4. Can this patent be designed around?
Potentially, competitors can modify chemical structures or delivery approaches to avoid infringement, but such alterations must navigate the scope of the claims explicitly.

5. What is the strategic significance of this patent in the pharmaceutical industry?
It provides a competitive advantage by securing exclusive rights to innovative compounds or delivery methods, influencing licensing, R&D directions, and market dominance.


References

[1] U.S. Patent No. 10,835,515
[2] Relevant prior art patents and publications (if available), as identified during the patent landscape analysis.

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Drugs Protected by US Patent 10,835,515

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes 10,835,515 ⤷  Get Started Free Y TREATMENT OF ADULT PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) IN COMBINATION WITH DOCETAXEL ⤷  Get Started Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes 10,835,515 ⤷  Get Started Free Y TREATMENT OF ADULT PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER (NMCRPC) ⤷  Get Started Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes 10,835,515 ⤷  Get Started Free Y TREATMENT OF ADULT PATIENTS WITH METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MCSPC) ⤷  Get Started Free
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes 10,835,515 ⤷  Get Started Free Y TREATMENT OF PATIENTS WITH NON-METASTATIC CASTRATION RESISTANT PROSTATE CANCER ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,835,515

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Finland20150033Jan 30, 2015

International Family Members for US Patent 10,835,515

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Denmark 3250554 ⤷  Get Started Free
European Patent Office 3250554 ⤷  Get Started Free
Spain 2917549 ⤷  Get Started Free
Croatia P20220998 ⤷  Get Started Free
Hungary E058986 ⤷  Get Started Free
Japan 2018503662 ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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