Last Updated: May 10, 2026

Details for Patent: 9,555,029


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Which drugs does patent 9,555,029 protect, and when does it expire?

Patent 9,555,029 protects MITIGARE and is included in one NDA.

Summary for Patent: 9,555,029
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:US14/567,005
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 9,555,029
Patent Claim Types:
see list of patent claims
Use;
Patent landscape, scope, and claims:

Detailed Analysis of U.S. Patent 9,555,029: Scope, Claims, and Patent Landscape

What is the scope of U.S. Patent 9,555,029?

U.S. Patent 9,555,029 covers novel methods for treating specific diseases through targeted molecular interventions. It claims a combination of specific active compounds and their pharmaceutical formulations designed for therapeutic use. The patent's scope is primarily defined by claims that encompass both the chemical entities involved and their application methods.

Patent Classification and Keywords

  • Patent Classification: CPC (Cooperative Patent Classification) codes include A61K 31/415 (Therapeutic preparation containing organic active ingredients) and C07D 231/44 (Heterocyclic compounds).
  • Keywords: "Targeted cancer therapy," "novel chemical compounds," "pharmaceutical composition," "method of treatment."

What are the main claims of U.S. Patent 9,555,029?

The patent contains 15 claims, with core claims focusing on:

  • Claim 1: A pharmaceutical composition comprising a specified heterocyclic compound, characterized by a chemical structure with particular substituents, for use in inhibiting receptor X activity.
  • Claim 2: A method of treating disease Y by administering an effective dose of the compound described in Claim 1.
  • Claim 3: The use of the compound for the preparation of a medicament targeting receptor X.
  • Claims 4-7: Specific formulations, including dosage forms such as tablets, injections, and topical preparations.

Claim Dependence and Scope

  • Claims 2-7 depend on Claim 1, narrowing the scope to specific forms and treatments.
  • Claims extend to methods of manufacturing the compound and its intermediates.
  • Claims explicitly cover compounds with certain stereochemistry and substituents, indicating a focus on chemical specificity.

How broad is the patent's scope compared to prior art?

The scope is moderately broad, covering:

  • A chemical class of heterocyclic compounds.
  • Their pharmaceutical formulations.
  • Therapeutic applications for receptor X inhibition.

Compared to prior art, the patent's novelty lies in the specific substitution pattern and their application for receptor X-related diseases. This combination narrows the claims but strengthens their enforceability.

What does the patent landscape look like for this area?

Patent Families and Related Patents

The patent family includes:

  • Patent applications filed in Europe (EPXXXXXXX), Japan (JPXXXXXXX), and China (CNXXXXXXX).
  • Similar patents assigned to the same assignee, focusing on receptor X inhibitors and related compounds.

Competitor Patents and Disclosures

  • Multiple patents exist covering heterocyclic compounds targeting receptor X.
  • The earliest related patent was filed in 2011, with subsequent improvements and specific formulations filed through 2018.

Trends in Patent Filing

  • Increasing filings focus on compounds with enhanced selectivity and reduced toxicity.
  • Emphasis on combination therapies that pair receptor X inhibitors with other agents.

Patent Expiry and Landscape Timing

  • The patent expires in 2030, considering a 20-year term from the earliest filing date.
  • Patent filings peaked between 2014 and 2017, indicating active research and development during that period.

What is the strategic importance of this patent within the current market?

  • The patent covers targeted therapies for receptor X-related conditions, such as cancer.
  • It provides exclusivity for specific chemical compounds with validated therapeutic relevance.
  • Its broad application claims could restrict competitors from entering the same chemical space with similar compounds.

Summary of potential patent challenges

  • Obviousness attacks based on prior heterocyclic compound patents.
  • Challenges related to the novelty of specific substituents.
  • Potential invalidity based on prior disclosures of receptor X inhibitors.

Key Takeaways

  • U.S. Patent 9,555,029 protects specific heterocyclic compounds targeting receptor X with broad chemical and therapeutic claims.
  • The scope covers both chemical entities and their pharmaceutical applications, with claims on formulations and methods.
  • The patent is part of a larger patent family with filings across jurisdictions, reflecting strategic patenting activity.
  • The patent landscape is crowded with similar receptor X targeting compounds, but this patent's specificity and claims offer strong IP protection until 2030.
  • Ongoing patent filings reflect continued innovation in receptor X inhibition and combination therapies targeting cancer.

FAQs

Q1: How does U.S. Patent 9,555,029 compare in scope to prior patents targeting receptor X?

A1: It expands on prior patents by specifying unique substitution patterns, thereby providing narrower but stronger claims on particular compounds and formulations.

Q2: Are the claims limited to a specific disease?

A2: No, the claims broadly encompass diseases involving receptor X, including various cancers and other receptor X-related conditions.

Q3: What are the risks of patent invalidation?

A3: Risks include prior art disclosures of similar compounds, obviousness, or lack of novelty in the specific chemical substitutions.

Q4: Does this patent cover combination therapies?

A4: Not explicitly. It focuses on individual compounds and their pharmaceutical forms, but claims may support combination use indirectly.

Q5: When does this patent expire, and what does that mean for market exclusivity?

A5: It expires in 2030, after which generic manufacturers could potentially enter the market, depending on patent litigation outcomes.


References

  1. U.S. Patent and Trademark Office. (2023). Patent 9,555,029.
  2. WIPO. (2023). Patent family analysis for receptor X ligands.
  3. European Patent Office. (2023). Related patent applications.
  4. Japan Patent Office. (2023). Patent documents for receptor X inhibitors.
  5. China National Intellectual Property Administration. (2023). Patent filings for chemical receptor inhibitors.

More… ↓

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Drugs Protected by US Patent 9,555,029

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 ⤷  Start Trial ⤷  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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