Neurelis, Inc.

Company overview. Neurelis, Inc. is a privately held, venture-backed, commercial-stage neuroscience pharmaceutical company headquartered at 3430 Carmel Mountain Road, San Diego, California. Founded in 2007 by David F. Hale and Craig Chambliss (who remains president and CEO), the company is not publicly traded. It has raised roughly $221 million across multiple rounds, including a $114 million Series D in 2021 backed by HBM Healthcare Investments, LYZZ Capital, Cormorant Asset Management, and Decheng Capital. Third-party trackers estimate headcount around 100–190 employees; exact revenue is not publicly disclosed and estimates vary widely.

Products / operations. Neurelis develops and commercializes intranasal therapies for central nervous system disorders, focused on epilepsy and seizure rescue. Its sole marketed product is VALTOCO® (diazepam nasal spray), FDA-approved in January 2020 for acute treatment of seizure clusters in epilepsy patients aged six and older; it uses the Intravail® transmucosal absorption-enhancement technology and carries FDA orphan-drug exclusivity. Neurelis has licensed VALTOCO commercialization rights for Japan/Asia-Pacific to Aculys Pharma. Its pipeline reportedly includes an intranasal lorazepam candidate and an early-stage intranasal product for acute psychiatric agitation.

Patent-litigation posture. Neurelis is an operating company and an active two-way litigant, but its profile is that of a branded drugmaker enforcing its product patents, not an NPE. It appears as plaintiff in 5 of 8 tracked matters and as defendant in 3. The plaintiff suits — against Padagis, Lupin, Amneal, and Strides entities — are Hatch-Waxman Paragraph IV actions alleging that generic ANDA filers seeking to market diazepam nasal spray copies infringe Neurelis's VALTOCO formulation and method patents. The 3 defendant-side matters are Padagis-filed inter partes review petitions at the PTAB challenging those same patents (e.g., IPR2025-00464/465/466). All district-court cases sit in the District of Delaware — a standard Hatch-Waxman venue, not a plaintiff-friendly NPE venue like EDTX.

Notable context. The litigation cluster, running from a May 2024 suit against Padagis through 2026 filings against Strides and Amneal, centers on a family of benzodiazepine nasal-spray patents (covering diazepam dissolved with tocopherols, alcohols, and permeation enhancers such as dodecyl maltoside). The PTAB instituted Padagis's IPR challenges, and the Delaware actions have been consolidated, with a bench trial scheduled for 2027. All tracked disputes relate to generic entry against VALTOCO.