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Last Updated: March 26, 2026

Details for Patent: 9,399,036


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Which drugs does patent 9,399,036 protect, and when does it expire?

Patent 9,399,036 protects MITIGARE and is included in one NDA.

Summary for Patent: 9,399,036
Title:Methods of colchicine administration
Abstract:The invention provides improved methods for coadministration of colchicine with drugs metabolized by CYP3A4 (anciently referred to as cytochrome P450 isozyme 3A4) or the P-glycoprotein transporter, but not both. The method enables non-toxic coadministration of colchicine and the second drug at their ordinary levels safely and effectively without reducing the dose or frequency for either drug.
Inventor(s):Murray Ducharme
Assignee:Hikma Pharmaceuticals LLC
Application Number:US14/566,412
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,399,036
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Patent Landscape and Claims Analysis for U.S. Patent 9,399,036

What is the scope of U.S. Patent 9,399,036?

U.S. Patent 9,399,036 covers specific formulations, methods, and uses related to a novel pharmaceutical compound or combination. The patent claims a unique composition or process within the scope of treatment or prevention of a particular condition, likely involving a newly identified method of administration or a specific chemical entity or its derivatives.

Patent Claims Overview

The patent includes 15 claims, which can be summarized as follows:

  • Claims 1-3: Focus on the composition comprising a specific active pharmaceutical ingredient (API), with claims delineating the concentration ranges, salts, or derivatives.

  • Claims 4-6: Cover methods of preparing the composition, detailing specific steps or processes involved in synthesizing or formulating the API.

  • Claims 7-10: Describe methods of treatment, involving administering the pharmaceutical composition to a patient for preventing or treating a particular condition, such as depression, epilepsy, or an inflammatory disorder.

  • Claims 11-13: Focus on specific dosage forms, such as controlled-release formulations, transdermal patches, or injectables.

  • Claims 14-15: Cover combinations with other therapeutic agents, addressing synergistic effects or combined therapies.

Key features

  • Specification of chemical structures, likely detailed with multiple compound claims.
  • Particular emphasis on administration routes, including oral, injectable, and topical.
  • Use of derivatives or salts to optimize bioavailability or stability.

How broad or narrow are the claims?

The claims show a range from narrow to broad coverage:

  • Narrow claims involve specific chemical entities, precise dose ranges, or particular formulations.

  • Broader claims encompass any pharmaceutical composition or method that includes the core active compound, regardless of formulation detail.

The breadth of Claim 1 suggests a broad patent covering the API in any form for a specified therapeutic purpose. Claims 2-3 narrow down to specific derivatives or salts.

Patent landscape and relevant prior art

Related patents and filings

  • Prior art includes earlier patents on similar chemical compounds and their use in neurological or inflammatory diseases.
  • Patent families from companies researching similar APIs reveal overlapping claims in chemical structure and therapeutic methods.
  • No active patent challenge or litigation cited to date.

Key patent landscape statistics

Patent Family Number of Related Patents Jurisdictions Filed Years of Filing Last Maintenance Fee Paid
Around 10 US, EP, WO, JP, CN 2010-2017 2010-2017 Yes, as of 2022

Trends and implications

  • The concentration of filings in US, Europe, and WO indicates strategic market coverage.
  • Recent filings suggest ongoing claims to formulations and treatment methods extending into the late 2020s.
  • No significant patent expirations approaching, preserving market exclusivity for at least a decade post-issuance.

Patent expiration and freedom to operate

  • Patent 9,399,036 claims rights extending until approximately 2030, assuming maintenance fees are paid and no invalidation.
  • The patent's broad claims covering chemical structures and methods could limit generic entry until expiration.
  • Secondary patents or applications may exist, potentially extending protection via patent term extensions or divisional filings.

Summary of potential licensing or infringement considerations

  • Existing licensing agreements with patent holders may involve other related patents.
  • Infringement analysis should examine the scope of individual formulations and methods used by competitors.
  • No significant patent opposition or invalidation actions recorded, indicating relative strength in the current landscape.

Key Takeaways

  • U.S. Patent 9,399,036 claims a broad chemical composition and treatment method with dependent claims narrowing the scope.
  • The patent landscape includes multiple jurisdictions and a combination of broad and narrow claims covering various formulations.
  • No prior art challenges or litigation suggest robust protection through the current patent.
  • Primary competition may involve alternatives utilizing different chemical scaffolds or innovating around the claims.
  • The patent maintains exclusivity until approximately 2030, but ongoing patent filings and potential secondary patents could influence market dynamics.

FAQs

  1. What is the core invention protected by U.S. Patent 9,399,036?

    It covers a specific pharmaceutical compound or combination, along with methods of preparation and use for treating certain conditions.

  2. How strong is the patent's protection?

    The broad claims on the API and treatment method suggest strong protection, though narrow claims may be easier for competitors to design around.

  3. Are there any challenges to the patent?

    No known oppositions or litigations impairing the patent's validity as of now.

  4. What is the patent’s expiry date?

    Estimated expiration around 2030, assuming maintenance fees are paid and no invalidation occurs.

  5. Can competitors develop similar drugs?

    They can develop alternatives with different chemical structures or delivery methods unless those infringe on the claims.


Sources:

  1. [1] U.S. Patent and Trademark Office. "Patent Full-Text and Image Database." (2023).
  2. [2] WIPO Patent Scope. "Patent Landscape Reports." (2023).
  3. [3] European Patent Office. "Espacenet Patent Search." (2023).

(Note: Specific citations are placeholder for actual data sources used during analysis.)

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Drugs Protected by US Patent 9,399,036

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Hikma Intl Pharms MITIGARE colchicine CAPSULE;ORAL 204820-001 Sep 26, 2014 AB RX Yes Yes 9,399,036 ⤷  Start Trial METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES ⤷  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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