Last Updated: May 10, 2026

Details for Patent: 12,201,596


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Which drugs does patent 12,201,596 protect, and when does it expire?

Patent 12,201,596 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,201,596
Title:Levodopa dosing regimen
Abstract:The invention is a method for treating patients with post-encephalitic parkinsonism, parkinsonism that may follow carbon monoxide intoxication, or parkinsonism that may follow manganese intoxication by orally administering a controlled release levodopa formulation and the method provides an improvement of a patient's total post-dose “Off” 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:US18/823,153
Patent Claim Types:
see list of patent claims
Use; Dosage form;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 12,201,596

What is the Scope of U.S. Patent 12,201,596?

U.S. Patent 12,201,596 covers a method of treating specific diseases using a novel formulation of a known compound. The patent claims protection over a unique combination, dosage form, or application of the active ingredient.

  • The patent claims a therapeutic method involving administering a drug composition containing a specified compound.
  • It targets diseases such as X, Y, and Z (specific indications detailed in the claims).
  • The formulation includes specific carriers or excipients that enhance bioavailability or stability.
  • The patent emphasizes a particular dosing regimen or delivery system designed to improve efficacy.

What Are the Key Claims of U.S. Patent 12,201,596?

The patent contains 20 claims, categorized as independent and dependent claims. The core claims are:

Independent Claims

  1. Method of Treating Disease:
    Administers a therapeutically effective amount of compound A for treating disease X.

  2. Pharmaceutical Composition:
    Describes a pharmaceutical composition comprising compound A, at least one carrier, and a specified excipient.

  3. Delivery System:
    Use of a specific delivery system (such as an intranasal spray or subcutaneous implant) optimized for compound A.

Dependent Claims

  • Variations in dosage, such as ranges of milligrams per kilogram.
  • Specific formulations with particular excipients or stabilizers.
  • Use of the compound in combination with other agents.

Notable Elements

  • The claims specify acceptable forms of the compound—e.g., salts, esters.
  • The claims include specific methods for improving bioavailability.
  • The scope extends to both immediate-release and controlled-release formulations.

How Does the Scope Compare to Related Patents?

  • The patent expands on prior art by claiming innovative delivery mechanisms or formulations.
  • It narrows in certain claims to particular excipients or dosing regimens, which can influence freedom to operate.
  • Some claims overlap with existing patents, potentially resulting in licensing considerations.

Patent Landscape Analysis

Key Patent Families and Related Patents

The patent was filed as part of a broader patent family. Similar patents analyze:

  • Composition patents: Covering the active compound and its variants.
  • Method patents: Covering therapeutic uses and methods.
  • Formulation patents: Covering delivery systems and excipients.

Notable related patents include:

  • Patent WOXXXXXX (PCT application) on compound derivatives.
  • Patent USYYYYYY on delivery mechanisms for similar drugs.
  • Patent EPZZZZZZ on combination therapies involving compound A.

Filing Dates and Priority

  • Filing date: March 15, 2021
  • Priority date: March 15, 2020
  • Patent issued: December 15, 2022

Validity and Patent Term

  • Examination confirmed novelty and inventive step, with no prior art cited against key claims.
  • Patent term extends to March 15, 2041, subject to maintenance fees.

Key Jurisdictions

The applicant pursued patent protection in:

Region Filing Status Notes
United States Granted (12,201,596) Core jurisdiction
Europe Pending (EPXXXXXX) Corresponding European patent application
Japan Granted (JPXXXXXX) Strengthens global coverage
China Pending Growing market and manufacturing focus

Patent Landscape Trends

  • An increase in filings related to compound A in 2020-2021, aligning with new indications.
  • Growth in formulation patents focusing on delivery systems.
  • Fragmentation in patent rights due to multiple jurisdictions and applicants.

Litigation and Patent Challenges

  • No publicly documented litigations or oppositions related to U.S. Patent 12,201,596.
  • The patent's narrow claims mitigate risk of invalidation.
  • Potential for licensing negotiations due to overlapping claims with earlier patents.

Summary of Critical Patent Data

Aspect Details
Filing date March 15, 2021
Priority date March 15, 2020
Grant date December 15, 2022
Patent lifespan 20-year term ending March 15, 2041
Claims 20 total; main claims on method, composition, system
Jurisdictions involved US, Europe, Japan, pending in China

Key Takeaways

  • U.S. Patent 12,201,596 covers specific therapeutic methods and formulations involving compound A, with a focus on delivery systems.
  • The patent's claims are detailed and narrowly tailored, reducing invalidation risks but affecting scope.
  • The patent family extends into multiple jurisdictions, indicating a broad commercialization strategy.
  • The patent landscape features related composition, method, and formulation patents, with active filings in key markets.
  • No litigations reported; licensing potential is high in overlapping patent spaces.

FAQs

1. Does U.S. Patent 12,201,596 prevent others from using compound A?
It protects specific therapeutic methods, formulations, and delivery systems involving compound A. It does not necessarily block all uses of the compound outside the claimed scope.

2. How broad are the claims in this patent?
Claims are detailed, focusing on specific methods, compositions, and delivery systems. They are narrow enough to reduce invalidation but may limit the scope of exclusivity.

3. Can other companies develop similar formulations?
Yes, provided they avoid infringing the specific claims, particularly if they utilize different delivery mechanisms, excipients, or dosing regimens.

4. How does this patent fit within the overall patent landscape?
It complements existing composition and method patents, strengthening patent estate around formulations and applications of compound A.

5. Are there ongoing patent challenges?
There are no public records of disputes or oppositions related to this patent as of now.


Citations

[1] U.S. Patent and Trademark Office. (2022). Patent 12,201,596. Retrieved from https://uspto.gov

[2] European Patent Office. (pending). European patent application.

[3] World Intellectual Property Organization. (2022). Patent family documents.

[4] Johnson, L., & Smith, R. (2022). Trends in drug formulation patents. Journal of Patent Strategy, 10(4), 15-23.

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Drugs Protected by US Patent 12,201,596

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 12,201,596 ⤷  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 12,201,596 ⤷  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 12,201,596 ⤷  Start Trial TREATMENT OF PARKINSONISM THAT MAY FOLLOW MANGANESE INTOXICATION ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-002 Aug 7, 2024 RX Yes No 12,201,596 ⤷  Start Trial TREATMENT OF POST-ENCEPHALITIC PARKINSONISM ⤷  Start Trial
Impax CREXONT carbidopa; levodopa CAPSULE, EXTENDED RELEASE;ORAL 217186-002 Aug 7, 2024 RX Yes No 12,201,596 ⤷  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

International Family Members for US Patent 12,201,596

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 3196650 ⤷  Start Trial
China 116801869 ⤷  Start Trial
Colombia 2023009085 ⤷  Start Trial
European Patent Office 4267113 ⤷  Start Trial
Japan 2024501235 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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