New Patent Protection Extends Aquestive’s Lead for Anaphylm Through 2037—First Oral Epinephrine Alternative Nears FDA Review

Patent Estate Expanded: Anaphylm Protected by New U.S. Patents

Aquestive Therapeutics has added two critical U.S. patents to its intellectual property estate for Anaphylm™, a novel sublingual film designed for the emergency treatment of severe allergic reactions. These patents extend market protection for Anaphylm into 2037, positioning the product with long-term competitive insulation as it approaches possible FDA approval.

Innovative Oral Option May Disrupt Epinephrine Injection Market

If approved, Anaphylm could become the first and only orally administered (sublingual) rescue treatment for anaphylaxis—a rapid, life-threatening allergic reaction that traditionally requires an immediate epinephrine injection. The device-free, patient-friendly film format could address one of the major pain points in emergency allergy care: fear and hesitation surrounding auto-injectors.

Key Anaphylm Features Aim for Practical Patient Adoption

According to Aquestive, Anaphylm is formulated as a thin film, similar in size to a postage stamp and smaller than a credit card, designed to dissolve quickly under the tongue without water or swallowing. The packaging is weather-resistant and easily portable, which may boost adherence among patients at risk of severe allergic reactions.

Intellectual Property Strategy Supports Global Pipeline

The issued patents cover unique prodrug compositions and film delivery technology—crucial assets as Aquestive pursues global patent applications for Anaphylm and other candidates in its Adrenaverse™ platform. This broad patent estate could deter competition and support premium pricing, provided the company can successfully bring Anaphylm to market.

Upcoming Milestone: FDA Decision Set for January 2026

Anaphylm’s regulatory fate hinges on an FDA review, with a Prescription Drug User Fee Act (PDUFA) target action date scheduled for January 31, 2026. If approved, Anaphylm may reshape the epinephrine market and become the go-to solution for patients hesitant to use injectable devices. However, the product still faces development, regulatory, and commercialization risks, as well as the challenge of winning over prescribers and patients accustomed to current standards.

Investor Takeaway: Patent Win Adds Value—But Commercial Success Hinges on FDA Approval

The new patents enhance Aquestive’s moat for Anaphylm at a critical moment, giving the company exclusive rights as it awaits potential regulatory approval. While this IP expansion is a positive sign for long-term strategy, investors and industry watchers will be monitoring clinical, regulatory, and commercial milestones over the coming quarters. With an FDA decision now in focus for early 2026, all eyes remain on whether Anaphylm can become the breakthrough oral alternative for emergency allergy care.

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