Aveva Drug Delivery Systems Prevails on Appeal, Federal Circuit Affirms Non-Infringement of ZTlido® Patents - Prepares for an Imminent Launch of its Generic Product with 180 Day Exclusivity

MIRAMAR, Fla., Aug. 5, 2026 — Aveva Drug Delivery Systems, Inc. ("Aveva"), a company in the DifGen Pharmaceuticals family, today announced that the U.S. Court of Appeals for the Federal Circuit has affirmed a District Court's opinion of non-infringement in the matter concerning Scilex's ZTlido® (lidocaine topical system) 1.8% product.

In Scilex Pharmaceuticals Inc., ITOCHU Chemical Frontier Corp., and Oishi Koseido Co., Ltd. v. Aveva Drug Delivery Systems, Inc., Appeal No. 2025-1002, the Appellate Court held that Aveva's proposed generic lidocaine topical system does not infringe U.S. Patent Nos. 9,283,174, 9,925,264, and 9,931,403, either literally or under the doctrine of equivalents.

About the Case

Scilex originally filed suit in June 2022 in the U.S. District Court for the Southern District of Florida after Aveva submitted an Abbreviated New Drug Application (ANDA) with a Paragraph IV certification challenging Scilex's Orange Book-listed ZTlido® patents. Following a bench trial in July 2024, the district court found no infringement and awarded Scilex no damages or injunctive relief. Scilex appealed to the Federal Circuit in March 2025.

Aveva was represented on appeal by Joseph Thomas Jaros of Rakoczy Molino Mazzochi Siwik LLP (Chicago, IL), who argued for defendant-appellee, along with William A. Rakoczy, Dylan Sacenti, and Conly S. Wythers.

What This Means Going Forward

With the Federal Circuit's affirmance, the path is now clear for Aveva to proceed toward imminent commercial launch of its generic lidocaine topical system 1.8% product, which will enjoy 180 day exclusivity.

About Aveva Drug Delivery Systems

Aveva Drug Delivery Systems (a DifGen company) is a fully integrated developer and manufacturer of sterile products, Transdermal Delivery Systems (TDS), and Oral Dissolvable Films (ODF). Aveva is licensed to manufacture, package, and market OTC & Rx TDS and ODF products and is DEA-approved for Schedule II & III controlled substance storage and handling. Aveva's licensed facilities, located in Miramar, FL, span four sites totaling 210,000 sq. ft.

About DifGen Pharmaceuticals

DifGen is a US-based global pharmaceutical company with a primary focus on developing complex, high-barrier-to-entry generics and specialty pharmaceutical products that help increase accessibility to high-quality medication, thereby contributing to the creation of next-generation healthy communities. DifGen consistently aspires to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. The firm has a talented team with some of the brightest minds, who have developed a holistic understanding of the nuances associated with developing unique, commercially viable, and difficult product lines across varying therapeutic areas and a broad array of dosage forms, including injectables, ophthalmic, topicals, biologicals, drug devices, soft gels, solid orals, and suspensions.

Any questions regarding this press release should be directed to Roberta Loomar, Global General Counsel, at +19546051796 or [email protected].