Aquestive Therapeutics Expands Patent Coverage for Anaphylm

Aquestive Therapeutics Expands Patent Coverage for Anaphylm

New patents extend protection for Anaphylm into 2037

Anaphylm (dibutepinephrine) Sublingual Film aims to be the first oral treatment for severe allergic reactions, including anaphylaxis

Aquestive Therapeutics, Inc. (NASDAQ: AQST), a company dedicated to improving patients' lives through innovative pharmaceuticals, has recently announced an exciting development regarding its flagship product, Anaphylm. The United States Patent and Trademark Office (USPTO) has granted two additional patents for Anaphylm, a novel sublingual film formulation designed for the rapid treatment of severe allergic reactions.

Dan Barber, President and CEO of Aquestive, expressed enthusiasm about the newly issued patents, which extend Anaphylm’s protection until at least 2037. “These patents cover the proprietary composition for Anaphylm, ensuring a robust foundation for our innovative delivery method of epinephrine,” he stated. This development underscores Aquestive’s commitment to addressing the considerable unmet needs of patients experiencing anaphylaxis, while also strengthening its intellectual property position in the market.

Understanding Anaphylm and Its Significance

Anaphylaxis is a life-threatening allergic reaction that typically requires immediate treatment with epinephrine. Traditional methods often involve injections, which can deter many patients due to the discomfort associated with needles. Anaphylm represents a potential breakthrough by offering a sublingual delivery option. This method allows the medication to dissolve under the tongue, making it easier and more comfortable for patients to use.

With a proposed target action date from the FDA set for January 31, 2026, Anaphylm is on the verge of potentially becoming the first oral medication approved for the emergency treatment of anaphylaxis. This could redefine how patients manage severe allergic reactions, especially for those who fear needles.

About the new Patents

The patents recently issued, numbered 12,427,121 and 12,443,850, focus on enhanced delivery systems for epinephrine compositions. These patents highlight the importance of the intricate formulations that facilitate mucosal absorption via film, providing a more accessible treatment option for patients.

This innovative technology is the result of years of research and development, as well as a diverse portfolio of pending and planned patent applications across multiple continents. As the company moves toward its goal of bringing Anaphylm to market, these patents will play a vital role in providing protection against competitors.

How Anaphylm Works

Anaphylm is constructed as a polymer matrix-based product that is small and lightweight, similar to a postage stamp. It begins to dissolve immediately upon contact, meaning no additional water or swallowing is required for administration. The packaging is designed for convenience and portability; it is thinner than a credit card and can endure various environmental conditions such as rain or sunlight.

The user-friendly design caters to patients needing quick access to emergency treatment, thereby potentially increasing compliance and efficacy during critical moments.

About Aquestive Therapeutics

Aquestaive Therapeutics specializes in creating pharmaceutical products that provide meaningful enhancement to patients’ lives, focusing on innovative delivery technologies. Their portfolio includes a range of orally administered products aimed at delivering complex molecules, which provide viable alternatives to conventional invasive treatments.

The company not only manufactures a variety of products currently marketed across the globe but also partners with other pharmaceutical firms to advance new drugs to the market using cutting-edge technologies, including the proprietary PharmFilm® platform. Additionally, Aquestive is focused on developing other candidate products aimed at treating conditions like severe allergic reactions and various dermatological issues.

Frequently Asked Questions

What is Anaphylm?

Anaphylm is a sublingual film medication containing dibutepinephrine, intended for the emergency treatment of severe allergic reactions.

What patents has Aquestive recently obtained?

Recently, Aquestive received U.S. patents for enhanced delivery compositions that will protect the Anaphylm formulation through at least 2037.

How does Anaphylm differ from traditional epinephrine delivery methods?

Anaphylm is delivered via a small sublingual film that dissolves without the need for injections, making it a more patient-friendly alternative.

When is the FDA expected to make a decision on Anaphylm?

The FDA's target action date for Anaphylm is scheduled for January 31, 2026.

What is the mission of Aquestive Therapeutics?

Aquestive Therapeutics aims to enhance patient care through innovative pharmaceuticals and delivery technologies, providing better alternatives to current treatment options.

About The Author

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