US 11021437

Summary of U.S. Patent 11,021,437

A concise summary of U.S. Patent 11,021,437 is provided below, including details on the patent's title, assignee, inventor, key dates, abstract, and a plain-language overview of its independent claims.

Title: Pharmaceutical formulation for sublingual or buccal delivery of epinephrine or a pro-drug thereof.

Assignee: Iono Pharma LLC.

Inventor: Hassan Almoazen.

Filing Date: November 9, 2017.

Issue Date: June 1, 2021.

Abstract: The patent describes a pharmaceutical composition for treating anaphylaxis that is designed for rapid delivery. One embodiment of the invention is a rapidly dissolving film for sublingual (under the tongue) or buccal (in the cheek) administration. These films contain either epinephrine or a novel epinephrine prodrug. The invention focuses on modifying the chemical properties of epinephrine to improve its absorption through the membranes in the mouth. This is achieved by creating prodrugs of epinephrine where the two hydroxyl groups on the benzene ring are modified with various acid moieties to form an ester bond with different alkyl chains. This modification is intended to increase the lipophilicity (the ability to dissolve in fats, oils, and lipids) of epinephrine, thereby enhancing its permeability through the sublingual and buccal tissues.

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Plain-Language Overview of Independent Claims

U.S. Patent 11,021,437 has three independent claims (claims 1, 2, and 4). Below is a simplified explanation of each.

Claim 1: This claim protects a specific chemical compound, which is a modified form of epinephrine (a prodrug), that is formulated as a pharmaceutical composition for delivery under the tongue or in the cheek. This formulation is a "rapidly dissolving film." The claim specifies that the compound must have a Log P value (a measure of its lipophilicity) between approximately 0.5 and 6.0 and must convert into its active form in the body within 1 to 6 minutes. The claim provides a list of chemical groups that can be used for the modification.

Claim 2: This claim is more specific than claim 1. It also covers a compound formulated as a rapidly dissolving film for sublingual or buccal administration with a 1-6 minute half-life. However, it narrows down the possible chemical modifications to the epinephrine structure, listing three specific options: CH3, CH2CH3, and CH(CH3)2.

Claim 4: This claim is highly specific and covers a single compound formulated for sublingual or buccal delivery. The compound is an epinephrine prodrug where the specific chemical modification is a -C(Cl)2CH3 group. This claim protects this exact molecular structure within a pharmaceutical composition designed for oral absorption.

It should be noted that this patent has been the subject of a petition for inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB), case number IPR2025-00874, filed by Aquestive Therapeutics, Inc. As of the current date, a search of the U.S. Court of Appeals for the Federal Circuit (CAFC) dockets for 2026 does not indicate any appeals related to this IPR proceeding.