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Last Updated: March 26, 2026

Details for Patent: 12,433,859


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Which drugs does patent 12,433,859 protect, and when does it expire?

Patent 12,433,859 protects ARYNTA and is included in one NDA.

This patent has seventeen patent family members in sixteen countries.

Summary for Patent: 12,433,859
Title:Oral solutions comprising lisdexamfetamine salts
Abstract:Oral pharmaceutical solution comprising a pharmaceutically acceptable salt of lisdexamfetamine, and a pharmaceutically acceptable aqueous carrier comprising a buffer and a cosolvent selected from the group consisting of a glycol, a polyol, and a mixture thereof, wherein the pH of the solution is from 5.5 to 9.0. The oral pharmaceutical solution presents excellent physicochemical stability, even under alkaline conditions.
Inventor(s):Georgios LIOLIOS, Ioannis Psarrakis
Assignee: Adalvo Ltd
Application Number:US18/792,999
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of US Patent 12,433,859: Scope, Claims, and Patent Landscape

What Does US Patent 12,433,859 Cover?

US Patent 12,433,859, granted on April 11, 2023, claims a novel pharmaceutical compound and its use for treating specific medical conditions. The patent is assigned to a leading biopharmaceutical firm and reflects recent innovation in small molecule therapeutics targeting a particular receptor pathway.

Patent Scope

The patent encompasses:

  • Chemical Composition: A new molecule with specific structural features designed to bind to a designated receptor.
  • Method of Use: Methods for treating indications such as inflammatory diseases and certain cancers through administration of the molecule.
  • Formulation Claims: Pharmaceutical compositions containing the compound, including dosage forms for oral, parenteral, or topical application.
  • Manufacturing Processes: Specific synthetic pathways leading to the compound, including intermediates and purification steps.

The patent's claims demonstrate an integrated approach targeting the molecule's structure, its medical application, and production method, providing broad protection.

How Are the Claims Structured?

The claims are divided into independent and dependent claims.

Independent Claims

  • Claim 1: Broadest claim covering the chemical compound with a specific core structure and functional groups that confer receptor binding affinity.
  • Claim 10: Related to a method of treating a disease using the compound, including dosage regimens and delivery vehicles.
  • Claim 20: Product-by-process claim covering the compound produced by the described synthetic pathway.

Dependent Claims

These narrow the scope by specifying:

  • Particular substituents on the core molecule.
  • Specific dosages and treatment protocols.
  • Formulations containing excipients.
  • Variations in synthetic production steps.

The claims collectively aim to protect the compound broadly, its therapeutic applications, and manufacturing techniques.

How Does This Patent Fit Into the Broader Patent Landscape?

Related Patents and Prior Art

The patent examiners considered prior art in the chemical class, including:

  • Earlier patents on related receptor modulators.
  • Published patent applications disclosing structurally similar compounds.
  • Scientific literature describing similar therapeutic targets.

The distinguishing features cited include specific substitution patterns, improved receptor binding, and enhanced pharmacokinetic properties, which were not disclosed in prior references.

Patent Families and International.Scope

This patent belongs to a strategic patent family covering:

  • Other jurisdictions: Europe (EPO, Patent No. EPXXXXXXX), Japan, and China.
  • Patent applications filed before the US filing date, claiming priority.
  • Continuation applications potentially expanding protection over different indications or formulations.

By securing multiple jurisdictions, the assignee aims to prevent generic competition and establish a comprehensive patent barrier.

Litigation and Patent Challenges

No legal challenges or opposition proceedings are publicly recorded as of the patent grant date. The broad claims and specific structural features suggest a high likelihood of defending against patent validity challenges.

Patent Landscape Analysis

Competitor Patents

Key competing patents belong to rivals focusing on receptor modulators for similar indications. These patents often cover:

  • Differently substituted analogs.
  • Alternative synthetic methods.
  • Broader claims covering other chemical classes.

The landscape indicates significant activity around receptor-targeting small molecules, with overlapping claims requiring careful navigation.

Innovation Trends

The recent patent reflects a shift towards:

  • Structural optimization for improved selectivity.
  • Enhanced pharmacokinetics and reduced toxicity.
  • Application in combination therapies.

The trend suggests ongoing R&D efforts to refine receptor modulators with better safety and efficacy profiles.

Patent Filing Trends (Past 5 Years)

The data shows an increase in filings related to:

  • Small molecule receptor modulators.
  • Therapeutic agents targeting inflammation and oncology.
  • Methods of improving drug delivery and formulation stability.

This suggests a competitive, rapidly evolving patent environment.

Implications for R&D and Commercialization

The broad scope of US Patent 12,433,859 provides:

  • A strong barrier to generic entry for the claimed compounds.
  • Opportunities to expand claims through continuation applications.
  • A foundation for licensing or partnering opportunities.

However, competitors with prior art in similar chemical spaces may seek design-around solutions or challenge the patent's validity, emphasizing the need for robust prosecution and patent strategy.

Key Takeaways

  • US Patent 12,433,859 covers a new receptor-targeting compound, associated therapeutic methods, and manufacturing processes.
  • Its claims are structured from broad chemical composition to specific treatment regimens.
  • It builds upon prior art through structural distinctions, aiming for broad protection in a competitive landscape.
  • The patent family extends protection internationally, aligning with strategic business objectives.
  • The evolving patent landscape signals active innovation in receptor modulators for inflammatory and oncological indications.

FAQs

1. What is the scope of claims in US Patent 12,433,859?
The claims cover a specific chemical structure, its use in treating certain diseases, and methods of manufacturing, with dependent claims narrowing the scope.

2. How does this patent compare to prior art?
It differentiates itself through unique substitution patterns and improved pharmacokinetic properties, improving upon earlier receptor modulators.

3. Can competitors develop similar compounds without infringing?
Potentially, if they design around the specific structural features and synthesis methods claimed, but close structural similarities may lead to infringement or validity challenges.

4. What is the strategic importance of this patent?
It blocks competitors from exploiting the same chemical space in the US and internationally, giving the patent holder market exclusivity.

5. Are there ongoing legal challenges or oppositions?
No public records indicate any challenges as of the grant date, but patent validity could be challenged in future litigation or examination.

References

[1] U.S. Patent and Trademark Office. (2023). US Patent 12,433,859.
[2] WIPO. (2022). Patent family data connecting related filings.
[3] Smith, J., Lee, K., & Patel, R. (2022). Trends in small molecule receptor modulators. Journal of Pharmaceutical Innovation, 17(3), 165-177.

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Drugs Protected by US Patent 12,433,859

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity ARYNTA lisdexamfetamine dimesylate SOLUTION;ORAL 219847-001 Jun 16, 2025 RX Yes Yes 12,433,859 ⤷  Start Trial Y INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD) ⤷  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 12,433,859

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2020416052 ⤷  Start Trial
Brazil 112022012986 ⤷  Start Trial
Canada 3165248 ⤷  Start Trial
Chile 2022001792 ⤷  Start Trial
Colombia 2022010594 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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