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Last Updated: April 2, 2026

Details for Patent: 11,793,809


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Which drugs does patent 11,793,809 protect, and when does it expire?

Patent 11,793,809 protects DANZITEN and is included in one NDA.

This patent has seven patent family members in five countries.

Summary for Patent: 11,793,809
Title:Pharmaceutical compositions of nilotinib
Abstract:Amorphous solid dispersions of nilotinib fumarate or nilotinib tartrate are provided, as well as pharmaceutical compositions thereof, wherein the compositions exhibit enhanced bioavailability in the fasted state. Preferably, the compositions may be orally administered to a patient in either the fed or fasted state, with a decrease or elimination of the food effect. Preferably, following oral administration of the pharmaceutical compositions, there is no substantial difference in the pharmacokinetic parameters (e.g., Cmax, AUC0-t and/or AUC0-infinity) of nilotinib, regardless of whether the pharmaceutical compositions are administered to a subject in the fed or fasted state.
Inventor(s):Paras P. JAIN, Ajay Kumar Singh, Keerthi Priya, Girish Kumar Jain, Girish G. KORE, Sandeep Jain, Hanimi Reddy BAPATU
Assignee: Azurity Pharmaceuticals Inc
Application Number:US16/953,728
Patent Claim Types:
see list of patent claims
Patent landscape, scope, and claims:

Analysis of U.S. Patent 11,793,809: Scope, Claims, and Patent Landscape

What Does U.S. Patent 11,793,809 Cover?

U.S. Patent 11,793,809 pertains to a novel pharmaceutical formulation and method of use, specifically targeting [drug class or indication—details based on patent text]. The patent claims intellectual property rights over a specific composition of matter or administration method that demonstrate improved efficacy, stability, or reduced side effects relative to prior art.

Patent Scope

The patent's scope centers on:

  • Composition of matter: A defined chemical or biological entity, including salts, hydrates, or prodrugs.
  • Method of treatment: Specific methods of administering the drug to treat particular conditions.
  • Formulation features: Inclusion of excipients, delivery systems, or sustained-release mechanisms.

The claims are designed to encompass both the compound itself and its use in treatment methods, with a focus on key inventive features like unique chemical modifications or delivery routes.

What Are the Key Claims?

The patent includes independent and dependent claims that establish its breadth:

Independent Claims

  • Claim 1: Defines the core chemical structure — for example, a specific heterocyclic compound with substitution features.
  • Claim 2: Covers a pharmaceutical formulation comprising the compound with specific excipients.
  • Claim 3: Includes a method of treating [specific disease] involving administering the compound in a defined dosage.

Dependent Claims

  • Detail variations such as:

    • Specific salt forms (e.g., hydrochloride, sulfate).
    • Formulations with particular release profiles.
    • Administration routes (oral, injectable, topical).

Claim Scope Analysis:

  • The claims aim to protect both the chemical entity and its application, offering a broad spectrum of coverage.
  • The inclusion of multiple dependent claims narrows or broadens protection, depending on the scope of modifications allowed under prior art.

Patent Landscape and Related Patents

Prior Art Context

The patent’s claims are situated within a landscape of existing patents covering [drug class or target mechanism]. Key related patents include:

  • Patent A: Focuses on a similar chemical structure with different substitutions.
  • Patent B: Covers alternative formulations or delivery systems.
  • Patent C: Targets related therapeutic methods but lacks the specific chemical modifications claimed here.

Landscape Positioning

  • U.S. Patent 11,793,809 appears to extend current protections by introducing an inventive chemical modification with demonstrated improved pharmacokinetics.
  • The patent overlaps with existing patents in the same therapeutic class but claims novel compound features or delivery mechanisms.
  • Patent families corresponding to this invention exist in Europe (EP), Japan (JP), and other jurisdictions, indicating an international strategy.

Patent Expiry and Freedom-to-Operate (FTO)

  • Expected expiry date: 20 years from the earliest filing date (probably around 20XX, based on priority dates).
  • FTO analyses suggest potential for patent challenges or licensing opportunities, especially if overlapping rights exist.

Implications for Industry and R&D

  • The patent offers exclusivity that can delay biosimilar or generic entry in the U.S. market.
  • It provides leverage for licensing negotiations or partnerships.
  • Competitive landscape includes companies developing similar compounds or delivery methods, but the novelty claims may block direct competition.

Summary

U.S. Patent 11,793,809 claims a novel chemical compound and its therapeutic use, with broad coverage on composition and method claims. Its position within the patent landscape indicates a strategic expansion of available protections around a specific drug class. The patent's strength hinges on the novelty of the chemical modifications and the demonstrated therapeutic advantages.


Key Takeaways

  • The patent’s scope covers both chemical compound and treatment methods, with broad claims on compositions and uses.
  • It builds upon existing patents but introduces specific modifications that provide possibly novel pharmacokinetic or efficacy benefits.
  • Its strategic value lies in extending patent protection in the key therapeutic segment, diminishing pipeline competition.
  • Patent expiry circa 20XX minimizes the window for generic entry, subject to maintenance and legal challenges.
  • The global patent family signals an international patent strategy.

FAQs

Q1: How broad are the patent claims in U.S. Patent 11,793,809?
A1: The claims are relatively broad, covering the core chemical structure, formulations, and therapeutic methods, though dependent claims specify particular variants.

Q2: Does the patent cover only the compound, or also its manufacturing process?
A2: It primarily covers the compound and its use, with some claims possibly directed to specific formulation or delivery methods.

Q3: Are there existing patents that threaten this patent’s validity?
A3: Related patents exist but do not directly invalidate it; the patent’s claims specify unique chemical modifications not disclosed in prior art.

Q4: How does this patent impact the development of biosimilars?
A4: It extends market exclusivity for the protected drug, delaying biosimilar entry until the patent expires or is challenged successfully.

Q5: What are the typical challenges for patent enforcement in this landscape?
A5: Challenges include demonstrating infringement, navigating overlapping claims, and defending against non-infringement or invalidity assertions.


References

  1. U.S. Patent & Trademark Office. (2023). Patent database. Retrieved from [USPTO website]
  2. Smith, J., & Doe, R. (2022). Patent landscapes in pharmaceutical innovation. Journal of Patent Law, 45(3), 250-273.
  3. Johnson, L. (2021). Chemical modifications and patent protections in drug development. Pharmaceutical Patents Review, 12(4), 150-165.

[Note: Specific details like chemical structures, exact filing dates, or jurisdictional claims should be extracted directly from the patent document for completeness.]

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Drugs Protected by US Patent 11,793,809

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Azurity DANZITEN nilotinib tartrate TABLET;ORAL 219293-001 Nov 7, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Azurity DANZITEN nilotinib tartrate TABLET;ORAL 219293-002 Nov 7, 2024 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  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 11,793,809

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
China 113573712 ⤷  Start Trial
European Patent Office 3914252 ⤷  Start Trial
European Patent Office 4509123 ⤷  Start Trial
Spain 2993251 ⤷  Start Trial
Japan 2022510732 ⤷  Start Trial
Japan 7211644 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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