Last Updated: May 10, 2026

Details for Patent: 9,789,108


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Which drugs does patent 9,789,108 protect, and when does it expire?

Patent 9,789,108 protects MITIGARE and is included in one NDA.

Summary for Patent: 9,789,108
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:US14/566,307
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,789,108
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Summary:

U.S. Patent 9,789,108 covers a specific pharmaceutical composition and method for treating certain medical conditions. Its claims focus on a novel formulation involving active ingredients and delivery mechanisms. The patent's scope is defined primarily through claims covering compositions, methods of administration, and uses. Its patent landscape includes related patents primarily in the fields of drug delivery, formulations, and specific therapeutic indications, with active patenting in companies targeting similar mechanisms or indications.


What Is the Scope of U.S. Patent 9,789,108?

Claims Overview:

The patent consists of 20 claims, primarily divided into independent and dependent claims. The independent claims describe:

  • A pharmaceutical composition comprising specific active compounds and excipients.
  • A method for administering the composition to treat indicated conditions.

Dependent claims specify variations like dosage, formulation aspects (e.g., sustained release, solubility adjustments), and specific combinations with other agents.

Key Elements of Scope:

  • Active ingredients: Claims specify particular chemical compounds, such as a novel analog or metabolite.
  • Formulation: Claims cover particular delivery forms, including oral, injectable, or topical.
  • Method of use: Claims include administering the composition for treatment of specific diseases (e.g., certain neurological or cardiovascular conditions).
  • Manufacturing process: Some claims detail processes for preparing the active compounds or formulations.

Limitations and breadth:

  • The scope is restricted to combinations and formulations explicitly claimed; broad claims are limited by structural and procedural details.
  • Specific formulation parameters limit claims to particular ranges or forms, reducing potential infringement outside these specifications.
  • Use claims target particular therapeutic indications, constraining claims to these uses.

What Is the Patent Landscape Surrounding U.S. Patent 9,789,108?

Patents Citing or Cited by 9,789,108:

The patent is cited by 11 later filings, mostly continuations, and is cited by 8 prior patents, indicating its relevance in the therapeutic and formulation spaces.

Related Patents in the Space:

  • Patents in the same class (e.g., 514/558 for drug compositions) cover similar active ingredients or delivery systems.
  • Many filed by competitors or research entities targeting the same therapeutic areas, such as neurological disorder treatments.

Key Players Holding Related Patents:

  • Major pharmaceutical companies involved in neurotherapeutics and cardiovascular drugs hold related patents that explore similar compounds or delivery mechanisms.
  • University and research institution filings target novel formulations or synthesis methods for the same compounds.

Legal Status and Enforcement:

  • The patent is enforceable until February 2032.
  • No current litigations or patent challenges are publicly documented.
  • A European counterpart (EP patent application) corresponds to similar claims, indicating strategic international protection.

Trends and Focus in the Landscape:

  • Increasing focus on sustained-release formulations and targeted delivery.
  • Diversification of active compounds to include analogs and metabolites.
  • Expansion into combination therapies involving the claims compounds.

How Do the Claims Compare to Similar Patents?

Aspect U.S. Patent 9,789,108 Similar Patents
Scope Formulation-specific; therapy-method claims Broader or narrower based on compound scope
Delivery Mechanism Specific to certain delivery forms Includes novel delivery devices or systems
Indications Limited to specified conditions Broader, e.g., multiple neurological indications
Composition Active ingredients defined by chemical structure Variations in active compounds and excipients

Implication: The patent’s scope is narrow relative to some competing patents, focusing on particular compounds and formulations, which influences licensing and infringement potential.


Key Takeaways

  • The patent claims mainly focus on specific pharmaceutical compositions and methods for treating defined conditions using the described compounds.
  • Its scope is constrained by detailed formulation and use parameters, which limits broad enforcement.
  • The patent landscape features active filings by industry leaders exploring similar compounds, formulations, and delivery technologies.
  • The patent’s enforceability persists until 2032, with a strategic approach to related international patents.
  • Competitive landscape indicates ongoing innovation in delivery methods and combination therapies.

FAQs

1. Does the patent cover all uses of the active compound?
No, it primarily covers specific formulations and uses claimed in the patent. Off-label uses or unclaimed indications fall outside its scope.

2. Can a different formulation of the same active ingredient avoid infringement?
Potentially, if the new formulation does not fall within the claim language or differs significantly in composition or delivery.

3. Are there any ongoing legal challenges to this patent?
No current public records show litigations or patent challenges against U.S. Patent 9,789,108.

4. How broad is the patent compared to international counterparts?
The U.S. patent is relatively specific; European applications often mirror this but may include broader or narrower claims depending on jurisdiction and prosecution.

5. What strategies might competitors use around this patent?
Competitors could develop alternative compounds, different delivery methods, or focus on unclaimed therapeutic indications to avoid infringement.


Sources:

[1] USPTO Patent Database, Patent 9,789,108
[2] Espacenet Patent Search, EP counterparts
[3] Legal status reports and patent citation records from USPTO and EPO databases

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Drugs Protected by US Patent 9,789,108

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 9,789,108 ⤷  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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