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Last Updated: July 12, 2025

Details for Patent: 11,185,497


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Which drugs does patent 11,185,497 protect, and when does it expire?

Patent 11,185,497 protects TRUDHESA and is included in one NDA.

This patent has thirteen patent family members in ten countries.

Summary for Patent: 11,185,497
Title:Intranasal delivery of dihydroergotamine by precision olfactory device
Abstract: Methods are provided for acutely treating migraine headache with or without aura. The methods comprise administering to a subject with migraine headache an effective dose of a liquid pharmaceutical composition comprising dihydroergotamine (DHE) or a salt thereof, wherein the dose is administered by an intranasal delivery device that provides, following intranasal administration, (a) a mean peak plasma DHE concentration (C.sub.max) of at least 750 pg/ml, (b) with a mean time to C.sub.max (T.sub.max) of DHE of less than 45 minutes, and (c) a mean plasma AUC.sub.0-inf of DHE of at least 2500 pg*hr/ml. Also provided are kits for acutely treating migraine with or without aura in which a liquid pharmaceutical composition comprising DHE or DHE salt is contained within a sealed vial that is attachable to a precision intranasal olfactory delivery device packaged therewith.
Inventor(s): Hoekman; John D. (Seattle, WA), Satterly; Kelsey H. (Seattle, WA), Shrewsbury; Stephen B. (Fallbrook, CA), Youmans; Scott (Bothell, WA), Fuller; Christopher (Seattle, WA)
Assignee: Impel Neuropharma, Inc. (Seattle, WA)
Application Number:17/062,364
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Delivery; Device;
Patent landscape, scope, and claims:

United States Patent 11,185,497: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

The United States Patent 11,185,497, titled "Intranasal delivery of dihydroergotamine by precision olfactory device," is a significant innovation in the field of pharmaceutical delivery systems. This patent, assigned to Woodward Specialty LLC, presents a novel method for delivering dihydroergotamine (DHE) intranasally, which is particularly relevant for treating conditions such as migraine headaches.

Patent Overview

Publication Number and Authority

The patent number is US11185497B2, and it was granted by the United States Patent and Trademark Office (USPTO)[4].

Prior Art and Background

The patent builds upon existing knowledge in the field of intranasal drug delivery, particularly focusing on the delivery of DHE. Prior art includes various methods and devices for intranasal administration, but this patent introduces a precision olfactory device that enhances the bioavailability and efficacy of DHE[4].

Claims Analysis

Independent and Dependent Claims

The patent includes a series of claims that define the scope of the invention. Independent claims outline the core aspects of the invention, such as the precision olfactory device and the method of delivering DHE. Dependent claims further specify and narrow down these core aspects, providing additional details on components like propellants, pharmaceutical compositions, and the device's design[4].

Key Claim Elements

  • Precision Olfactory Device: The device is designed to target specific olfactory receptors, enhancing the absorption of DHE.
  • Pharmaceutical Composition: The patent specifies the use of DHE mesylate and other components like propellants and excipients.
  • Method of Delivery: The method involves administering a single dose of DHE using the precision olfactory device, which is compared to other delivery methods in terms of bioavailability[4].

Scope of the Invention

Technical Scope

The invention is technically scoped to include:

  • A precision olfactory device with specific components such as a propellant and a pharmaceutical composition containing DHE.
  • A method for delivering DHE intranasally using this device.
  • The device's design and functionality, including its ability to target olfactory receptors and enhance bioavailability[4].

Therapeutic Scope

The therapeutic scope is focused on treating migraine headaches and other conditions where DHE is effective. The patent highlights the device's ability to provide rapid and effective relief by optimizing the delivery of DHE directly to the brain via the olfactory pathway[4].

Patent Landscape

Global Patent Family

The patent is part of a global patent family, with related applications filed in various countries. Using tools like the Global Dossier provided by the USPTO, one can access the file histories of related applications from participating IP Offices, which helps in understanding the global scope and status of the patent[1].

Prior Art and Citation Analysis

The Common Citation Document (CCD) application can be used to consolidate prior art cited by all participating offices for the family members of this patent application. This helps in visualizing the search results for the same invention produced by several offices on a single page[1].

Competing Patents and Technologies

Other patents in the field of intranasal drug delivery, such as those related to nasal pharmaceutical compositions and devices, are relevant for understanding the competitive landscape. For example, patents like US-5169849-A, which discusses nasal pharmaceutical compositions, provide context on existing technologies and how the current patent innovates beyond them[2].

Economic and Market Impact

Market Need and Demand

The market demand for effective migraine treatments is significant, and the precision olfactory device addresses this need by providing a more efficient and targeted delivery method. This can lead to increased market share and revenue for the assignee, Woodward Specialty LLC.

Cost and Efficacy

The patent's focus on enhancing bioavailability and reducing the dose required for effective treatment can lead to cost savings and improved patient outcomes. This can be a competitive advantage in the pharmaceutical market, where cost and efficacy are critical factors[4].

Legal Status and Enforcement

Current Status

The patent is currently active, as indicated by its legal status. However, it is important to note that the legal status is subject to change based on various factors, including litigation and maintenance fees[4].

Office Actions and Litigation

Using tools like the Patent Examination Data System (PEDS) and the Global Dossier, one can track office actions and any litigation related to the patent. This information is crucial for understanding the patent's enforceability and potential challenges[1].

Conclusion

United States Patent 11,185,497 represents a significant advancement in intranasal drug delivery, particularly for the treatment of migraine headaches. The precision olfactory device and the method of delivering DHE outlined in this patent have the potential to revolutionize the way pharmaceuticals are administered, offering improved efficacy and patient outcomes.

Key Takeaways

  • Precision Olfactory Device: The patent introduces a novel device that targets olfactory receptors to enhance DHE absorption.
  • Improved Bioavailability: The method of delivery using this device shows improved bioavailability compared to other methods.
  • Therapeutic Focus: The invention is primarily aimed at treating migraine headaches and other conditions where DHE is effective.
  • Global Patent Family: The patent is part of a global family with related applications in various countries.
  • Competitive Landscape: The patent innovates beyond existing technologies in intranasal drug delivery.

FAQs

What is the main innovation of United States Patent 11,185,497?

The main innovation is the precision olfactory device designed to enhance the bioavailability of dihydroergotamine (DHE) when delivered intranasally.

How does the precision olfactory device work?

The device targets specific olfactory receptors to improve the absorption of DHE, leading to more effective treatment of conditions like migraine headaches.

What are the key components of the pharmaceutical composition in this patent?

The composition includes DHE mesylate, propellants, and other excipients that facilitate the intranasal delivery.

How does this patent compare to other intranasal drug delivery methods?

This patent offers improved bioavailability and a more targeted delivery method compared to existing technologies, enhancing the efficacy of DHE treatment.

What is the current legal status of the patent?

The patent is currently active, but its status can change based on factors like litigation and maintenance fees.

Sources

  1. USPTO - Search for patents: https://www.uspto.gov/patents/search
  2. Unified Patents - Nasal Pharmaceutical Compositions: https://portal.unifiedpatents.com/patents/patent/US-5169849-A
  3. USPTO - Patent Claims Research Dataset: https://www.uspto.gov/ip-policy/economic-research/research-datasets/patent-claims-research-dataset
  4. Google Patents - Intranasal delivery of dihydroergotamine by precision olfactory device: https://patents.google.com/patent/US11185497B2/en

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Drugs Protected by US Patent 11,185,497

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Impel Pharms TRUDHESA dihydroergotamine mesylate SPRAY, METERED;NASAL 213436-001 Sep 2, 2021 RX Yes Yes 11,185,497 ⤷  Try for Free NASAL ADMINISTRATION OF DIHYDROERGOTAMINE MESYLATE BY METERED SPRAY FOR THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA ⤷  Try for Free
>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 11,185,497

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2019205318 ⤷  Try for Free
Australia 2022202900 ⤷  Try for Free
Brazil 112020013744 ⤷  Try for Free
Canada 3088942 ⤷  Try for Free
China 111936140 ⤷  Try for Free
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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