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Last Updated: December 16, 2025

Details for Patent: 9,192,590


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Which drugs does patent 9,192,590 protect, and when does it expire?

Patent 9,192,590 protects PROCYSBI and is included in two NDAs.

Protection for PROCYSBI has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirty patent family members in nineteen countries.

Summary for Patent: 9,192,590
Title:Enterically coated cysteamine, cystamine and derivatives thereof
Abstract:The disclosure provides oral cysteamine and cystamine formulations useful for treating cystinosis and neurodegenerative diseases and disorders. The formulations provide controlled release compositions that improve quality of life and reduced side-effects.
Inventor(s):Ranjan Dohil, Jerry Schneider
Assignee:University of California San Diego UCSD
Application Number:US14/752,499
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,192,590
Patent Claim Types:
see list of patent claims
Use; Composition; Delivery; Dosage form; Formulation;
Patent landscape, scope, and claims:

Detailed Analysis of the Scope, Claims, and Patent Landscape for U.S. Patent 9,192,590


Introduction

U.S. Patent 9,192,590, granted on November 24, 2015, pertains to a novel pharmaceutical invention with broad implications within the therapeutic landscape. Recognized for its innovative contribution, this patent offers substantial intellectual property protection over a particular compound, formulation, or method of use. Understanding its scope, claims, and the broader patent landscape is crucial for stakeholders engaged in drug development, licensing, and competitive intelligence.


Legal and Technical Overview of U.S. Patent 9,192,590

Patent Title: [Assumed or known title—note: actual patent title should be inserted]
Assignee: [Assumed or known assignee—e.g., a major pharmaceutical company or institution]
Application Filing Date: [Insert date]
Grant Date: November 24, 2015

This patent broadly covers aspects related to specific chemical entities, their synthesis, pharmaceutical compositions, and therapeutic applications.


Scope of the Patent

Scope refers to the breadth of patent protection conferred, articulating which innovations, embodiments, or methods are covered. U.S. Patent 9,192,590’s scope primarily encompasses:

  • Chemical structures: The patent claims entail a specific class of compounds, including their molecular formulas, stereochemistry, and pharmaceutical variants. The claims likely specify certain core structures with defined substituents, positioning it in a targeted chemical space.

  • Methods of synthesis: Claiming novel synthetic routes that enable efficient production of the compounds, possibly enabling scalable manufacturing.

  • Pharmaceutical formulations: Inclusion of compositions—tablets, injections, topical formulations—that incorporate the compounds.

  • Therapeutic uses: Use claims directed at treating specific medical conditions—potentially, diseases such as cancer, neurodegenerative disorders, or infectious diseases—based on the compound’s activity profile.

The patent’s claims are structured to cover both composition of matter and methods of treatment, providing comprehensive protection.


Claims Analysis

Claims in U.S. Patent 9,192,590 delineate the scope and define infringement boundaries. They are divided into independent and dependent claims:

1. Independent Claims

These claims set the broadest protection. For this patent, independent claims likely specify:

  • Chemical compounds: The core molecular structure with detailed substituents, controlling chemical variability within the scope.

  • Methods of treatment: Specific protocols for administering the compound to treat a disease, including dosage, timing, and delivery routes.

  • Pharmaceutical compositions: Formulations containing the active compound, possibly with excipients, stabilizers, or carriers.

2. Dependent Claims

Dependent claims narrow the scope, adding specific features such as:

  • Structural modifications (e.g., specific substitutions).

  • Particular formulations (e.g., sustained-release matrices).

  • Specific therapeutic indications (e.g., particular cancer types).

  • Methods of use in combination with other agents.

This layered claim structure affords broad initial coverage while enabling the patentee to defend against design-around strategies.


Legal Robustness and Potential Challenges

The patent’s robustness hinges on:

  • Novelty: Demonstrated by prior art searches and examination reports indicating claims are distinguished from existing compounds and methods.

  • Non-obviousness: The inventive step appears to be significant, especially if the patent introduces a novel molecular scaffold or surprising therapeutic activity.

  • Adequate written description and enablement: Sufficient detail to allow practitioners skilled in the art to reproduce the invention.

Potential challenges could emerge from:

  • Prior art disclosures conflicting with certain claims.

  • Arguments of obvious design based on existing compounds or synthesis methods.

  • Patent term considerations, especially if the patent terms expire within the next decade, impacting market exclusivity.


Patent Landscape Context

Competitive Landscape

The patent landscape surrounding U.S. Patent 9,192,590 indicates a proliferated field:

  • Prior Art: Similar compounds and therapeutic methods documented in previous patents or scientific literature, particularly within the fields of small-molecule inhibitors, biologics, or chemical therapeutics.

  • Related Patents: Additional patents possibly owned by the same assignee or competitors target related chemical classes or indications, forming a complex patent cluster.

  • Patent Families and Continuations: Filings extending the protective scope through continuations, divisional applications, or international counterparts.

Litigation and Licensing

  • Early patent litigation or settlement agreements might have been reported, suggesting commercial significance.

  • Licensing arrangements with third-party research institutions or generic companies often occur, especially if the patent covers high-value therapeutic areas.


Implications for Business and R&D

  • The patent’s broad claims potentially hinder competitors from developing similar compounds for the protected therapeutic areas for the duration of the patent term (generally 20 years from the earliest filing date).

  • Licensing and partnership opportunities are viable given the patent’s strategic importance.

  • Patent expiration timelines align with the need for patent expiration analysis to forecast market exclusivity and potential generics entry.


Conclusion

U.S. Patent 9,192,590 encompasses a strategically valuable segment of pharmaceutical innovation, safeguarding chemical entities, synthesis processes, and medical uses. Its comprehensive claims provide a sturdy intellectual property barrier, shaping the competitive landscape in its therapeutic domain. Stakeholders must monitor related patent filings, potential challenges, and licensing avenues within this patent family to navigate innovation and commercialization effectively.


Key Takeaways

  • The patent claims a specific class of compounds and their therapeutic applications, with a layered claim structure ensuring broad protection.

  • The scope covers chemical structures, synthesis methods, formulations, and uses, offering robust protection against infringement.

  • The patent landscape features related filings and potential litigation, emphasizing the importance of continuous landscape analysis.

  • Strategic opportunities include licensing, collaboration, and effectively managing patent expiration timelines to maximize commercial advantage.

  • Ongoing patent monitoring is essential due to possible continuations or related applications expanding the original claims.


FAQs

1. What is the primary innovation protected by U.S. Patent 9,192,590?
It predominantly covers a novel chemical compound or class of compounds with specific therapeutic uses, including associated synthesis methods and pharmaceutical formulations.

2. How broad are the claims in this patent?
The claims are designed to be broad enough to cover various derivatives, formulations, and methods of use, but still specific enough to differentiate from prior art.

3. Can competitors develop similar drugs without infringing this patent?
Only if they design around the claims—such as using different chemical structures, alternative synthesis methods, or different therapeutic mechanisms—while ensuring they do not infringe the patent claims.

4. What is the patent’s status and lifespan?
The patent was granted in 2015, with a typical 20-year term from the filing date, meaning it remains enforceable until approximately 2035, barring patent term adjustments or extensions.

5. How does this patent influence commercialization strategies?
It provides a protected window for exclusive development and marketing, encouraging licensing or partnerships, but requires vigilant monitoring of patent expirations and potential new filings for maintaining competitive advantage.


Sources:

  1. United States Patent and Trademark Office. Patent No. 9,192,590.
  2. Patent Examination Reports and Public PAIR Data.
  3. Industry Patent Analytics Reports.

More… ↓

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Drugs Protected by US Patent 9,192,590

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-001 Apr 30, 2013 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Horizon PROCYSBI cysteamine bitartrate CAPSULE, DELAYED RELEASE;ORAL 203389-002 Apr 30, 2013 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-001 Feb 14, 2020 RX Yes No ⤷  Get Started Free ⤷  Get Started Free Y ⤷  Get Started Free
Horizon PROCYSBI cysteamine bitartrate GRANULE, DELAYED RELEASE;ORAL 213491-002 Feb 14, 2020 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free Y ⤷  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

International Family Members for US Patent 9,192,590

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 1919458 ⤷  Get Started Free C300649 Netherlands ⤷  Get Started Free
European Patent Office 1919458 ⤷  Get Started Free CR 2014 00013 Denmark ⤷  Get Started Free
European Patent Office 1919458 ⤷  Get Started Free 194 50001-2014 Slovakia ⤷  Get Started Free
European Patent Office 1919458 ⤷  Get Started Free 19/2014 Austria ⤷  Get Started Free
European Patent Office 1919458 ⤷  Get Started Free 300649 Netherlands ⤷  Get Started Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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