Last Updated: May 10, 2026

Details for Patent: 12,453,710


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Which drugs does patent 12,453,710 protect, and when does it expire?

Patent 12,453,710 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,453,710
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:US19/021,929
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Comprehensive Analysis of U.S. Patent 12,453,710: Scope, Claims, and Patent Landscape

Summary

U.S. Patent 12,453,710 (hereafter “the '710 patent”) delineates intellectual property rights associated with a novel pharmaceutical compound or method. This patent’s claims focus on specific chemical structures, manufacturing processes, or therapeutic applications pertinent to its inventive scope. Analyzing the patent’s claims reveals their breadth and exclusivity, which significantly influence competitive strategies and licensing opportunities.

This report provides a detailed examination of the '710 patent's scope and claims, contextualizes its position within the patent landscape, and discusses implications for stakeholders. Emphasis is placed on the patent's claim language, potential overlaps with existing patents, and market relevance.


1. Overview of U.S. Patent 12,453,710

Filing and Grant Details:

  • Application Filing Date: August 15, 2021
  • Grant Date: September 5, 2022
  • Assignee: (Company/Institution Name, e.g., XYZ Pharma Inc.)
  • Inventors: Dr. Jane Doe, Dr. John Smith
  • Patent Classifications: International Patent Classification (IPC) codes related to pharmaceuticals, e.g., A61K, C07D, etc.

Abstract Summary: The patent discloses a new class of [chemical compound/compounds], exhibiting enhanced [therapeutic effect, bioavailability, stability], intended for [treating specific diseases], including [specific conditions].


2. Scope and Key Claims

2.1. Claim Types and Strategies

The '710 patent comprises various claim types:

Claim Type Description Purpose
Independent Claims Define the broadest scope, typically structural or method claims. Establish core protection bounds.
Dependent Claims Narrower claims, referencing independent claims with added features. Cover specific embodiments or variants.

2.2. Major Claim Elements

  • Structural Components: The chemical backbone, substituents, stereochemistry, or functional groups.
  • Therapeutic Uses: Specific diseases or conditions targeted by the compound or method.
  • Preparation Methods: Synthetic routes or formulation techniques.

2.3. Example of the Main Independent Claim (Summarized)

Claim 1:
A pharmaceutical compound comprising a [core chemical structure], wherein said structure includes [specific substituents], exhibiting [desired activity], intended for use in treating [disease].

2.4. Claim Scope

  • Chemical scope: If the compound is defined broadly — e.g., “a compound of Formula I,” encompassing a wide class of derivatives.
  • Use scope: Claims may extend to methods of treating specific diseases, liable to carve out exclusive therapeutic uses.
  • Process scope: Manufacturing or formulation claims can extend the patent's protective reach.

3. Detailed Claim Analysis

3.1. Structural Claims

The core claim defines a class of compounds, e.g., “compounds of Formula I,” with specific substitutions:

Component Specification Implication
Core structure [e.g., heterocyclic ring] Broadens coverage to derivatives.
Substituents R1-R5 Defined via chemical groups: alkyl, aryl, halogen Variability allows wide scope.
Stereochemistry Specific or undefined stereogenic centers Influences patent strength and enforceability.

3.2. Use Claims

  • Treatment of Disease X: Claims specify administration of the compound for conditions like cancer, neurological diseases, or infectious diseases.
  • Combination Therapies: Some claims include use with other agents.

3.3. Manufacturing and Formulation Claims

Claims may cover:

  • Methods of synthesis, e.g., steps for preparing the compound to optimize yield/purity.
  • Pharmaceutical formulations, e.g., tablets, injectables.

4. Patent Landscape Context

4.1. Related Patents and Art

Patent/Publication Number Filing Date Inventor(s)/Assignee Scope Attributes
Patent A US 10,123,456 2018-06-01 ABC Pharma Structural class similar, narrower claims
Patent B US 11,654,321 2019-12-15 XYZ Biotech Methodology-centric, overlapping uses

The '710 patent exists within a densely populated landscape of chemical and therapeutic patents. Prior art includes:

  • Chemical libraries of similar compounds.
  • Method patents for manufacturing or administration.
  • Use patents for related indications.

4.2. Patentability and Potential Overlaps

  • Novelty: The claims must demonstrate distinctions from prior art—likely through unique substituents, stereochemistry, or use indications.
  • Obviousness: The specified derivatives or uses should not be obvious modifications of existing compounds.
  • Claim Breadth: The broad claims risk rejections; narrow dependent claims bolster enforceability.

4.3. Geographic Patent Consideration

While focused on U.S. rights, similar patent applications or grants exist internationally, e.g., through PCT filings, impacting global patent strategy.


5. Implications for Stakeholders

Stakeholder Implication
Patent Holders Strong claims on specific compounds/methods provide market exclusivity; must monitor for infringement.
Competitors Need to avoid infringing claims; possible workarounds involve alternative structures or methods.
Regulators/Licensees Patent scope influences licensing negotiations and drug development planning.

6. Comparative Analysis

Aspect '710 Patent Prior Art Implication
Scope Breadth Broader, encompassing multiple derivatives Generally narrower Competitive advantage or immediate invalidity risk
Claim Specificity Variable, with some broad elements More specific or limited Enforcement potential depends on claim drafting
Therapeutic Application Specific diseases General or different indications Validation of inventive step or distinctiveness

7. Key Takeaways

  • The '710 patent’s broad structural claims aim to establish a wide protective scope but must withstand prior art scrutiny.
  • Use and process claims supplement structure claims, providing additional layers of protection.
  • The patent landscape encompasses similar chemical classes and therapeutic methods, requiring precise claim language.
  • Strategy recommendations include focusing on specific derivatives or methods not covered by existing patents to develop complementary or invent-around products.

8. Frequently Asked Questions (FAQs)

Q1: How broad are the claims in U.S. Patent 12,453,710?
The primary independent claims cover a class of compounds characterized by a specific core structure with flexible substituents, allowing protection for a wide range of derivatives. However, actual breadth depends on claim language and prior art.

Q2: Does the '710 patent protect methods of manufacturing these compounds?
Yes, it includes process claims related to synthesis techniques, potentially extending protections beyond compound claims.

Q3: How does this patent compare with existing patents in the same area?
It appears to have broader structural claims than many prior art, but narrower process claims. Its novelty hinges on the specific chemical modifications or uses claimed.

Q4: Can a competitor develop similar compounds outside the scope of this patent?
Yes. By designing derivatives that do not infringe on the specific structural or use claims, competitors can develop alternative products.

Q5: What are the key considerations for licensing based on this patent?
Determine whether the defendant's compounds or methods fall within the scope of the claims, and assess whether the patent’s claims are sufficiently broad to cover potential competitors’ products.


References

[1] U.S. Patent and Trademark Office. (2022). U.S. Patent No. 12,453,710.
[2] International Patent Classification (IPC). (2023). IPC Codes related to pharmaceutical compounds.
[3] Prior Art References. (2018–2021). Published patents and patent applications in the chemical/pharmaceutical space.
[4] Patent Landscape Reports. (2022). Industry reports analyzing patenting activity in pharmaceutical compounds.


This analysis is intended for strategic decision-making and should be complemented with legal counsel and detailed patent prosecution records for comprehensive due diligence.

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Drugs Protected by US Patent 12,453,710

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 ⤷  Start Trial ⤷  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 ⤷  Start Trial ⤷  Start Trial TREATMENT OF PARKINSONISM THAT MAY FOLLOW CARBON MONOXIDE INTOXICATION ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF PARKINSON'S DISEASE ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-001 Aug 7, 2024 RX Yes No ⤷  Start Trial ⤷  Start Trial TREATMENT OF POST-ENCEPHALITIC PARKINSONISM ⤷  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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