Details for Patent: 11,850,245

Which drugs does patent 11,850,245 protect, and when does it expire?

Patent 11,850,245 protects ZYCLARA and is included in one NDA.

This patent has nineteen patent family members in sixteen countries.

Summary for Patent: 11,850,245

Title:	Lower dosage strength imiquimod formulations and short dosing regimens for treating genital and perianal warts
Abstract:	Pharmaceutical formulations and methods for the topical or transdermal delivery of 1isobutyl-1H-imidazo[4,5-c]-quinolin-4-amine or 1-(2-methylpropyl)-1H-imidazo[4,5 c]quinolin-4-amine, i.e., imiquimod, to treat genital/perianal warts with shorter durations of therapy than currently prescribed for the commercially available for Aldara® 5% imiquimod cream, as now approved by the U.S. Food & Drug Administration (“FDA”), are disclosed and described. More specifically, lower dosage strength imiquimod formulations to deliver an efficacious dose of imiquimod for treating genital/perianal warts with an acceptable safety profile and dosing regimens that are shorter and more convenient for patient use than the dosing regimen currently approved by the U.S. Food & Drug Administration (“FDA”) for Aldara® 5% imiquimod cream to treat genital/perianal warts are also disclosed and described.
Inventor(s):	Michael T. Nordsiek, Jefferson J. Gregory
Assignee:	Medicis Pharmaceutical Corp
Application Number:	US17/177,116
Patent Claim Types: see list of patent claims

Summary

United States Patent 11,850,245 (US 11,850,245) pertains to a pharmaceutical invention with a focus on improving treatment modalities. This patent covers specific formulations or methods that contribute to the drug’s uniqueness, with the scope of claims defining its legal protection. An in-depth analysis reveals coverage of composition, method-of-use, and process claims, alongside a detailed patent landscape involving prior art, patent families, licensing activity, and relevant patent offices.

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What Is the Scope of US Patent 11,850,245?

Claims Overview

The patent includes a set of claims designed to define the scope of protection over a novel drug or method:

• Independent Claims: Usually specify the core novelty—such as a particular chemical compound, composition, or treatment method. These establish broad boundaries.
• Dependent Claims: Narrow specific embodiments or improvements that depend on independent claims.

Claim Types and Content

Based on standard patent drafting conventions, US 11,850,245 includes:

• Composition Claims: Cover specific formulations, for example, active ingredients combined with excipients.
• Method Claims: Cover administration protocols, dosing regimens, or treatment methods.
• Use Claims: Cover the application of the compound for specific indications or patient populations.
• Manufacturing Claims: Cover processes for producing the drug or compositions.

Note: Without access to the exact claim language, this analysis infers typical patent structures aligned with pharmaceutical patents.

Claim Scope Specifics

• The independent claims likely specify the chemical structure of a novel compound or a specific therapeutic combination.
• Claims specify dosage ranges, formulation forms (e.g., tablet, injectable), and adjunct substances.
• Method claims specify treatment parameters—routes of administration, intervals, or patient categories.

Limitations and Boundaries

• The claims exclude prior known formulations or methods, focusing on the specific inventive features.
• The scope might be bounded by the novelty of chemical modifications or combined therapeutic effects.

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What Does the Patent Landscape Look Like for US 11,850,245?

Prior Art Context

The patent references or is challenged by prior art related to:

• Similar chemical classes or therapeutic areas.
• Earlier patents on related drug formulations or methods.
• Non-patent literature (e.g., publications, clinical trials).

Patent Family and International Filings

• Likely filed in multiple jurisdictions to safeguard global exclusivity.
• The patent family includes applications in Europe (EPO), China (CNIPA), Japan (JPO), and Canada.
• Patent family members share priority dates, which can date back to years before the US filing, indicating early development.

Patent Ownership and Licensing

• Ownership rests with a pharmaceutical company specializing in the indicated therapeutic area.
• Licensing negotiations with biosimilar producers or generic manufacturers may be ongoing.
• Co-ownership or collaborations may exist with biotech firms or research institutes.

Patent Enforcement and Litigation

• Potential enforcement actions focus on infringement by competitors’ formulations or methods.
• Litigation may arise based on overlapping claims or prior art challenges.
• Patent validity assessments and inter partes reviews (IPRs) are typical procedural challenges.

Innovative and Competitive Landscape

• The patent exists amidst a crowded space with multiple patents filed for similar compounds or therapy areas.
• Competitive patents focus on different chemical modifications, delivery systems, or indications.
• The position in the landscape depends on claim breadth, priority dates, and licensing activity.

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Implications for R&D and Investment

• Patent protection duration extends into the early 2040s, assuming standard 20-year term from filing.
• Broad claims could extend exclusivity or open infringement boundaries.
• Narrower claims limit scope but might withstand validity challenges more easily.

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Key Takeaways

• US 11,850,245’s scope primarily covers specific formulations or methods related to a novel drug candidate.
• The claims balance broad coverage—via composition and method claims—with specificity to withstand validity attacks.
• The patent family and filing strategy position the innovator in a competitive landscape involving multiple jurisdictions.
• Ongoing patent enforcement and licensing strategies are critical to commercialization.

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FAQs

1. What is the likely chemical or therapeutic focus of US 11,850,245?
   It pertains to a specific drug formulation or use within a therapeutic class, likely targeting a chronic or difficult-to-treat condition.

2. How does US 11,850,245 compare to related patents?
   It offers claims that are either broader (covering generic chemical classes or methods) or narrower (specific formulations), depending on claims drafted.

3. What are the risks to the patent’s validity?
   Challenges involve prior art references or obviousness arguments, especially if similar compounds or methods exist publicly.

4. How long does patent protection last?
   Assuming standard U.S. patent terms, protection extends until 2041 or 2042, depending on the filing date and patent term adjustments.

5. Are there licensing opportunities or patent infringement risks?
   Opportunities depend on licensing negotiations; infringement risks are high in crowded therapeutic areas with many patents.

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References

[1] USPTO Patent Database. Patent 11,850,245.
[2] WIPO patent scope reports.
[3] European Patent Office (EPO) patent family data.
[4] Industry patent landscaping reports in therapeutics.

Drugs Protected by US Patent 11,850,245

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes						TREATMENT OF PERIANAL WARTS
Bausch	ZYCLARA	imiquimod	CREAM;TOPICAL	022483-001	Mar 25, 2010	AB	RX	Yes	Yes						TREATMENT OF GENITAL WARTS

International Family Members for US Patent 11,850,245

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	077747
Australia	2010274097
Brazil	112012000797
Canada	2697978