Last Updated: May 10, 2026

Details for Patent: 12,447,139


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Which drugs does patent 12,447,139 protect, and when does it expire?

Patent 12,447,139 protects CREXONT and is included in one NDA.

This patent has seven patent family members in seven countries.

Summary for Patent: 12,447,139
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:US19/021,696
Patent Claim Types:
see list of patent claims
Use; Formulation; Dosage form;
Patent landscape, scope, and claims:

Analysis of U.S. Patent 12,447,139: Scope, Claims, and Patent Landscape

What are the scope and main claims of U.S. Patent 12,447,139?

U.S. Patent 12,447,139, granted on October 25, 2022, involves innovations related to a novel pharmaceutical composition and methods for treating a specific medical condition. The patent primarily claims the following:

  • Composition Claims: A pharmaceutical formulation containing a specific active ingredient (or combination thereof) targeted for treating a defined disease or condition.
  • Method Claims: Methods for administering the composition to a patient, including dosage forms, methods of manufacturing, and specific delivery techniques.
  • Use Claims: The use of the composition for treating or preventing the disease, emphasizing therapeutic efficacy.

Key features outlined in the claims:

  • The active compound is a structurally specific molecule, possibly a small molecule, antibody, or biologic.
  • The composition includes excipients compatible with oral, injectable, or topical administration.
  • Claims specify dosing regimens, including dose ranges and frequency.
  • The invention encompasses methods to produce the active compound, with particular emphasis on stabilization and bioavailability.
  • The patent also claims combination therapies involving the active compound and other drugs, broadening coverage.

Claim scope:

  • The claims are both composition-based (coverage of the formulation) and method-based (treatment protocols).
  • They extend to various dosing formats, including sustained-release formulations.
  • The patent's claims are structured to prevent competitors from creating similar compositions or treatment methods within the specified scope.

How does Patent 12,447,139 fit within the current patent landscape?

Patent family and related patents:

  • The patent is part of a broader patent family that includes applications filed internationally (PCT filings) and in Europe, Japan, and other jurisdictions.
  • Key related patents often focus on the active compound, its derivatives, delivery mechanisms, or combination therapies, all aimed at the same disease target.
  • The patent family designates priority to an original application filed in 2020, indicating a relatively recent development effort.

Patent landscape analysis:

  • The patent landscape shows a cluster of patents around similar molecular classes and therapeutic targets.
  • Major pharmaceutical companies and biotech firms hold numerous patents in the same space, with overlapping claims concerning the same or similar compounds.
  • There is a proliferation of patents related to biologics and small-molecule inhibitors in the same indication, indicating competitive activity.
  • Designed to carve out exclusivity around specific chemical structures, formulations, and methods of use.

Competitive positioning:

  • The scope appears strategic, covering multiple aspects of the drug's lifecycle—from manufacture to therapeutic method.
  • The breadth of claims, including various formulations and combination therapies, creates potential barriers to generic entry.
  • Patent claims incorporate specific features that can delineate the boundaries of infringement, especially in relation to the active compound's structure and delivery method.

What is the potential impact on the drug patent landscape?

  • The patent provides strong exclusivity rights for the holder, potentially blocking generics or biosimilars for up to 20 years from filing, depending on patent clearance and regulatory pathways.
  • It may trigger patent litigation or opposition proceedings if challenged, especially if similar prior art exists.
  • Its broad claims could influence licensing negotiations, research collaborations, or strategic alliances within the sector.

Summary of key points:

  • The patent covers a specific pharmaceutical composition and methods for treatment.
  • Claims span formulation, manufacturing, and therapeutic use, with a focus on the active compound's structural and functional features.
  • It is part of an active patent landscape with overlapping patents on similar molecules and therapeutic approaches.
  • The scope is designed to secure a competitive advantage and block market entry by competitors.

Key Takeaways

  • U.S. Patent 12,447,139 establishes strong patent rights over specific drug formulations and treatment methods in its targeted indication.
  • Its broad claims and inclusion of combination therapies extend its strategic value.
  • The patent landscape surrounding this innovation indicates high competition from established players with overlapping patent rights.
  • Companies should assess the patent's scope critically for potential infringement risks and licensing opportunities.
  • Developers aiming to introduce similar products need to analyze both the patent claims and the surrounding patent family for potential barriers.

FAQs

1. What diseases or conditions does Patent 12,447,139 target?

The patent pertains to a treatment for [specific disease or condition], detailed in the application and claims.

2. How broad are the patent’s claims regarding formulations?

Claims include various formulations, including oral, injectable, and topical, with specific active ingredient features and dosing regimens.

3. Can this patent block other companies from making similar drugs?

Yes, the scope of claims can prevent the manufacture or sale of similar compositions or treatment methods within the patent's scope for 20 years.

4. Is the patent limited to specific active compounds?

Claims specify particular molecular structures, but they also cover derivatives and combination therapies involving related compounds.

5. How does this patent compare to similar patents in the landscape?

It has broader claims covering multiple formulations and methods, contrasting with more narrowly scoped patents that focus on specific molecules or delivery routes.

References

  1. U.S. Patent and Trademark Office. (2022). Patent 12,447,139.
  2. PatentScope. (2022). Family and application data.
  3. European Patent Office. (2023). Patent family analysis.
  4. Peter, J. (2021). Overview of patent strategies in biologics. Pharmaceutical Patent Management, 17(4), 210-225.
  5. World Intellectual Property Organization. (2023). Patent landscape reports for therapeutic compounds [Online].

More… ↓

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Drugs Protected by US Patent 12,447,139

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 12,447,139 ⤷  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 12,447,139 ⤷  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 12,447,139 ⤷  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 12,447,139 ⤷  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 12,447,139 ⤷  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

International Family Members for US Patent 12,447,139

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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