Aquestive Therapeutics Broadens Patent Estate for Anaphylm™

Rhea-AI Summary

Aquestive Therapeutics (NASDAQ: AQST) announced the USPTO issued two new U.S. composition patents for Anaphylm (dibutepinephrine) Sublingual Film, extending patent protection through at least May 4, 2037. The patents (U.S. 12,427,121 and U.S. 12,443,850) cover epinephrine prodrug formulations and film-based oral mucosal absorption enabled by the company's PharmFilm and Adrenaverse technologies.

Anaphylm is positioned as a device-free, oral sublingual alternative to injectable epinephrine for severe allergic reactions. The FDA PDUFA target action date for Anaphylm is January 31, 2026. Each patent expiration is subject to any applicable extensions.

Positive

• Two U.S. composition patents issued for Anaphylm
• Patent protection extended through May 4, 2037
• Claims cover epinephrine prodrugs and oral sublingual film delivery
• First potential device-free oral rescue option for anaphylaxis

Negative

• U.S. approval is not guaranteed; PDUFA date Jan 31, 2026
• Patent terms are subject to extensions, creating timing uncertainty

Insights

Pharmaceutical IP and Regulatory Analyst

New U.S. composition patents extend exclusive rights for Aquestive’s sublingual epinephrine film through at least 2037, ahead of an FDA action.

Aquestive strengthens its intellectual property by securing two U.S. composition patents that cover prodrug formulations and film-based oral mucosal delivery for Anaphylm™. Composition claims provide the strongest form of patent protection for a drug’s specific chemical formulation and delivery approach, which can deter direct generic copies and support market exclusivity if the product gains regulatory approval.

Regulatory and commercial value depends on FDA approval and successful market uptake. The announcement explicitly ties patent protection to formulations designed for sublingual absorption; however, approval remains pending with a January 31, 2026 PDUFA target action date. Key risks include the conditional nature of commercial exclusivity (approval required), possible patent challenges, and the limited scope patents may have if competitors design around the claimed compositions.

Watch the January 31, 2026 PDUFA decision and any subsequent patent term adjustments or litigation; the patents are stated to expire on May 4, 2037. These milestones will determine whether the strengthened patent estate translates into a meaningful competitive barrier and commercial value.

• New patents extend protection for Anaphylm™ into 2037
• Anaphylm (dibutepinephrine) Sublingual Film, if approved by the FDA, will be the first and only oral medication for the rescue treatment of severe allergic reactions, including anaphylaxis

WARREN, N.J., Oct. 08, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced the United States Patent and Trademark Office (USPTO) has issued two additional U.S. patents related to Anaphylm, the Company’s novel epinephrine prodrug sublingual film.

“We are pleased with the issuance of these additional patents for Anaphylm, extending protection for the product through at least 2037,” said Dan Barber, President and CEO of Aquestive. “These claims cover the proprietary composition for Anaphylm, which enables the oral sublingual film delivery of an epinephrine prodrug. By leveraging our proprietary technology platforms, PharmFilm^® and Adrenaverse™, in this inventive way, we are addressing significant unmet needs in severe allergic reactions, while reinforcing patent protection for Anaphylm. These patents are the result of a broad intellectual property strategy that includes many other multi-continent patent applications pending and planned.”

The USPTO has issued Aquestive U.S. patent number 12,427,121 entitled “Enhanced Delivery Epinephrine Compositions,” and U.S. patent number 12,443,850 entitled “Enhanced Delivery Epinephrine and Prodrug Compositions.” These composition of matter patents feature formulations including prodrugs of epinephrine and other components designed to facilitate oral mucosal absorption via film. Each patent is expected to expire on May 4, 2037, subject to any extensions thereof.

Anaphylaxis is a severe, rapid allergic reaction requiring immediate application of epinephrine, but many patients hesitate to use epinephrine injections due to fear of needles. Aquestive’s product candidate Anaphylm is the first sublingual epinephrine film, offering a device-free, patient-friendly alternative, if approved by the United States Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date for Anaphylm is scheduled for January 31, 2026.

About Anaphylm™ (dibutepinephrine) Sublingual Film
Anaphylm (dibutepinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the FDA. Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.

About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has four commercialized products marketed by the Company and its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm^®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel for possible various dermatology conditions. For more information, visit Aquestive.com and follow us on LinkedIn.

Forward-Looking Statement
Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (dibutepinephrine) Sublingual Film through clinical development and approval by the FDA; that Anaphylm will be the first and only oral administration of epinephrine and accepted as an alternative to existing standards of care treatment, if Anaphylm is approved by the FDA; the extent and breadth of our existing and planned patents for Anaphylm and our Adrenaverse pipeline in the United States and abroad; that these patents will protect Anaphylm from competitors; regarding the advancement of the Company’s product candidate AQST-108 through clinical development and regulatory approval by the FDA for possible various dermatology conditions; regarding the potential benefits our products and product candidates could bring to patients; and other statements that are not historical facts.

These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm (including for pediatric patients) and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing of the NDA for AQST-108, or the failure to receive FDA approval at all of Anaphylm and AQST-108; risk of the Company’s ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments and questions regarding the Company’s clinical trials and the NDA for Anaphylm and other concerns of the FDA identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk associated with the success of any competing products, including generics; risk associated with the development of a sales and marketing capability for commercialization of our product candidates, including Anaphylm; risks associated with the potential impact on the value of the Company of the sale or outlicensing of our product and product candidates, including Anaphylm; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to commence principal payments under our 13.5% Notes in 2026, to fund future clinical development and commercial activities for our product candidates, including Anaphylm, should these product candidates be approved by the FDA; risk that our manufacturing capabilities will be sufficient to support demand of our product candidates, if approved by the FDA, and our licensed products in the U.S. and abroad; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. of Anaphylm and our other product candidates, should these product candidates be approved by the FDA, and for our licensed products in the U.S. and abroad; risk of the size and growth of our product markets; risks associated with failure to comply with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the USPTO; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and product candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against Aquestive, including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and rising interest rates; risks related to the impact of the COVID-19 global pandemic and other pandemic diseases on our business; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; risks related to the uncertainty about presidential administration initiatives and their impact on our business, including the imposition of tariffs and other trade restrictions; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.

PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com

FAQ

What patents did Aquestive receive for Anaphylm (AQST) and when do they expire?

The USPTO issued U.S. patents 12,427,121 and 12,443,850 covering epinephrine prodrug film formulations, each expected to expire on May 4, 2037.

How could the new Anaphylm patents affect AQST shareholders?

The patents extend exclusivity for the Anaphylm film through 2037, potentially protecting commercial rights if FDA approval is granted.

When is the FDA decision expected for Anaphylm (AQST)?

The Prescription Drug User Fee Act (PDUFA) target action date is January 31, 2026.

What makes Anaphylm different from existing epinephrine treatments for AQST?

Anaphylm is a sublingual epinephrine prodrug film designed as a device-free, oral alternative to injectable epinephrine, if approved.

Which technologies underpin Anaphylm's formulation for AQST?

Aquestive cites its PharmFilm and Adrenaverse platforms as enabling oral mucosal absorption of the epinephrine prodrug.

Are the new Anaphylm patents final and free of future changes?

The patents are issued but their expirations are noted as subject to any extensions, so timing could change.