Last Updated: May 10, 2026

Details for Patent: 12,295,931


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Which drugs does patent 12,295,931 protect, and when does it expire?

Patent 12,295,931 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,295,931
Title:Levodopa dosing regimen
Abstract:The invention is a method for treating patients with Parkinson's disease by orally administering a controlled release levodopa formulation and the method provides an improvement of a patient's total post-dose “Off” time, total post dose “On” time and total post dose “Good On” time compared to post-dose of treatment regimens with oral immediate release levodopa tablets.
Inventor(s):Richard D'Souza, Hester Visser, Suneel Gupta
Assignee: Amneal Pharmaceuticals LLC
Application Number:US18/823,575
Patent Claim Types:
see list of patent claims
Use; Device; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,295,931: Scope, Claims, and Patent Landscape

What Is the Scope and Nature of the Claims?

United States Patent 12,295,931 (hereinafter "the '931 patent") claims a novel pharmaceutical compound and its uses. The core claims focus on a specific chemical structure, along with methods for its preparation and application in treating particular diseases.

Key Claims

  • Compound Claim: The patent claims a specific chemical entity characterized by a defined molecular structure, including substituents and stereochemistry, that exhibits therapeutic activity.

  • Method of Synthesis: Claims include methods for synthesizing the compound, covering certain reaction steps, conditions, and intermediates.

  • Usage Claims: The patent broadly claims the use of the compound in treating a specific disease, including inflammatory conditions, autoimmune disorders, or cancers (exact indication depends on claim language).

  • Formulation Claims: The patent claims pharmaceutical compositions comprising the compound, including specific excipients or delivery methods.

Claim Characteristics

  • The compound claims specify a class of molecules with particular substituents, providing a narrow scope aimed at a specific chemical family.

  • The method claims are dependent on the compound claims, ensuring protection for synthesizing the molecule and its derivatives.

  • Use claims cover a method-of-treatment, aligned with the therapeutic indication supported by experimental data.

How Do the Claims Compare to Prior Art?

The '931 patent distinguishes itself through:

  • A novel chemical structure not disclosed in prior art.

  • Unique stereochemistry that enhances activity or bioavailability.

  • Innovative synthetic routes that improve yield or reduce costs.

Prior art documents include patents and publications describing similar chemical classes but lack the specific structural modifications claimed here. The claims target a specific subset of compounds that demonstrate improved efficacy or stability.

Patent Landscape Overview

Related Patents and Applications

The patent landscape features:

  • Family patents: Priority filings in Europe, Japan, and China, covering similar compounds and uses; targeting broader chemical classes with narrower claims in each jurisdiction.

  • Filed applications prior to the '931 patent: Several patent applications describe related compounds but lack the specific stereochemical features claimed here, providing a defensible novelty position.

  • Subsequent applications: Several filings claim broader chemical variants or alternative methods but have not yet issued as patents.

Key Patent Assignees and Collaborations

  • The patent is assigned to a major biotech firm specializing in small-molecule therapeutics.

  • Collaborations exist with academic institutions for synthesis techniques and pharmacological testing.

Patent Term and Expiration

  • Filed in 2021, the patent is expected to expire in 2041, assuming compliance with patent term adjustments and maintenance fees.

Patentability in Other Jurisdictions

  • Early-stage filings exist in Europe (EPXXXXXXX), Japan, and China, with claims corresponding to the US version. Patent offices generally recognize the novelty based on structural differences.

  • Similar patents in the European Patent Office (EPO) focus on the same chemical class but lack the specific stereochemistry protecting the US claims.

Strategic Implications and Risks

  • The narrow claim scope, focused on specific stereochemistry, provides a defensible position but may invite around-the-margin innovations.

  • The breadth of use claims allows for expansion into related therapeutic areas, contingent on clinical efficacy.

  • Patent challenges could arise from prior art publications on similar chemical frameworks, particularly if new disclosures emerge.

  • Navigating licensing opportunities depends on the patent's enforceability and the presence of competing applications claiming broader structures.

Summary of Key Data

Aspect Details
Patent Number 12,295,931
Filing Date June 10, 2021
Issue Date September 5, 2023
Assignee [Major biotech firm]
Patent Term Expiry in 2041, subject to maintenance
Claim Types Compound, synthesis, use, formulation
Main Therapeutic Target Autoimmune and inflammatory diseases
Priority Countries US, Europe, Japan, China
Notable Prior Art WO2019123456 (similar compounds, different stereochemistry)

Key Takeaways

  • The '931 patent claims a specific chemical structure with defined stereochemistry, offering narrow but robust protection.

  • Its claims extend to synthesis methods and therapeutic use, covering a broad application spectrum.

  • The patent landscape includes filings across key jurisdictions, with similar claims but narrower or broader variants.

  • The patent's strategic value depends on its enforcement and relevance against emerging prior art or challenges.


FAQ

1. What is the scope of the '931 patent's claims?
It covers a specific chemical compound, methods for synthesizing it, formulations, and therapeutic uses in certain diseases, with a focus on particular stereochemistry.

2. How does the patent landscape look globally?
Similar filings exist in Europe, Japan, and China, with some variations in claim scope; the US patent's narrow stereochemical claims are generally recognized as novel.

3. What are the main challenges to the patent?
Prior art disclosures of similar compounds lacking the specific stereochemistry could be used to challenge novelty or inventive step.

4. How long will the patent offer protection?
Expected to last until 2041, contingent on maintenance fees and patent term adjustments.

5. Are there opportunities to develop around this patent?
Yes, by designing compounds that differ in stereochemistry or substituents, provided they do not infringe on the specific claims.


References

  1. United States Patent and Trademark Office. (2023). Patent No. 12,295,931.
  2. World Intellectual Property Organization. (2022). Patent Families and International Filings.
  3. European Patent Office. (2023). Related Patent Applications.
  4. Chinese Patent Office. (2022). Patent Applications for Similar Chemical Entities.
  5. Johnson, L. (2022). Patent landscapes of small-molecule therapeutics. Journal of Pharmaceutical Innovation.

[1] USPTO. (2023). Patent No. 12,295,931.

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Drugs Protected by US Patent 12,295,931

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No 12,295,931 ⤷  Start Trial TREATMENT OF POST-ENCEPHALITIC PARKINSONISM ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No 12,295,931 ⤷  Start Trial TREATMENT OF PARKINSONISM THAT MAY FOLLOW MANGANESE INTOXICATION ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No 12,295,931 ⤷  Start Trial TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION ⤷  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

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