Plaintiff
3 cases as plaintiff.
Company overview. Padagis US LLC is a Delaware-incorporated generic pharmaceutical company and a wholly owned subsidiary of Padagis LLC, based at 1251 Lincoln Road, Allegan, Michigan. The business began as Perrigo Company plc's prescription-generics division (founded 2004) and became a standalone company on July 6, 2021, after private-equity firm Altaris Capital Partners acquired the unit for roughly $1.55 billion. Padagis is privately held (PE-backed by Altaris) and reports over 1,300 employees across U.S. and Israeli sites; revenue is not publicly disclosed.
Products / operations. Padagis develops, manufactures, and markets generic prescription and OTC pharmaceuticals, focusing on extended topical dosage forms—creams, ointments, lotions, gels, foams, liquids, and nasal sprays—and says its dermatology product line is the largest in the U.S. It also markets Naloxone HCl nasal spray (an OTC opioid-overdose antidote) and holds legacy operations from Agis Industries and Paddock Laboratories, with manufacturing in Allegan, Michigan, and Minneapolis, Minnesota. The company specializes in Paragraph IV generics that challenge branded patents via FDA ANDAs.
Patent-litigation posture. Padagis is an operating company, not an NPE, and appears as an active two-way litigant: 3 tracked matters as plaintiff (PTAB inter partes review petitions) and 1 as defendant (District of Delaware). All tracked cases stem from a single Hatch-Waxman dispute with Neurelis, Inc. over generic versions of VALTOCO (diazepam nasal spray) for seizure clusters. The defendant case is Neurelis, Inc. v. Padagis LLC et al. (D. Del., filed May 8, 2024), an ANDA/Paragraph IV suit; Padagis's plaintiff-side matters are IPR2025-00464/00465/00466 challenging three Neurelis benzodiazepine-formulation patents. Venue is Delaware and the PTAB—not Eastern District of Texas.
Notable context. Padagis petitioned for IPR against Neurelis patents sharing a family whose parent patent ('876) was previously invalidated in IPR2019-00451; the PTAB instituted trial and the USPTO designated a related non-discretionary-denial ruling "informative" in January 2026. Padagis has also been a party to related Delaware ANDA cases filed by Neurelis in 2025–2026 (e.g., 1:25-cv-00821, 1:25-cv-01228), beyond the four tracked matters above.
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Padagis petitioned for inter partes review of the '414 patent, challenging claims 1–18 as obvious over Gwozdz and Meezan. Trial was instituted, and the case remains pending with no final written decision.
Inter partes review challenging claims 1-22 of the '546 patent. The Board instituted review on September 16, 2025. Neurelis filed a statutory disclaimer disclaiming claims 1-16 and 18-21, leaving claims 17 and 22 at issue, and no Final Written Decision has yet issued.
IPR proceeding challenging the '786 patent; institution decision issued around July 16, 2025, and the proceeding is active.