The complaint

The case is Shionogi Inc. v. Shanghai Auzone Biological Technology Co., Ltd., Auzone Biological Technology (USA) Ltd., and Auzone Biological Technology Pty Ltd, No. 2:26-cv-13323 (D.N.J.), filed October 13, 2026, ECF No. 1. Shionogi says it is a Delaware corporation with a place of business in Florham Park, New Jersey. The complaint says its allegations rest on knowledge as to Shionogi's own actions and on information and belief as to all other matters, and it alleges, on information and belief, that Shanghai Auzone is a Chinese company, that Auzone Biological Technology (USA) Ltd. is a Delaware company, and that Auzone Biological Technology Pty Ltd is an Australian company. The docket shows the case assigned to Judge Jennifer Choe-Groves of the Court of International Trade and Magistrate Judge Leda D. Wettre.

The complaint says that Shionogi acquired the U.S. RADICAVA ORS assets, including NDA No. 215446 and its Orange Book-listed patents, as of April 1, 2026, from the product's prior owner, and it lists more than a dozen related RADICAVA ORS patent actions pending in the District of New Jersey, including In re Radicava ORS, No. 25-03326, and No. 26-12063, filed September 14, 2026.

The application and the patent

The complaint alleges, on information and belief, that Shanghai Auzone holds 505(b)(2) NDA No. 219846 seeking approval to market AUKONTALS, an edaravone product for amyotrophic lateral sclerosis containing 90 milligrams of edaravone as three 30 milligram tablets, with RADICAVA ORS as the reference listed drug. It alleges, on information and belief, that Shanghai Auzone sent a notice letter dated October 6, 2026, with a certification under 21 U.S.C. 355(b)(2)(A)(iv) regarding the '586 patent. Shionogi says it has not received samples of the proposed product or its edaravone ingredient.

The '586 patent issued April 14, 2026. Claim 1 recites an edaravone suspension for human oral administration made of water, edaravone particles dispersed in the water, and a dispersant that keeps the particles in a solid state in the water, prepared by mixing edaravone particles with a D50 particle size of 10 to 50 micrometers and a D90 particle size of 50 to 200 micrometers with the water and dispersant, where the particles have a dissolution rate of 80 percent or more 30 minutes into a dissolution test under Method 2 of the Japanese Pharmacopoeia.

What the lawsuit alleges

Count 1 alleges that submitting NDA No. 219846 with the notice letter infringed the '586 patent under 35 U.S.C. 271(e)(2), and alleges, on information and belief, that the proposed product infringes at least independent claim 1, literally or under the doctrine of equivalents, and that commercial sales would infringe under 35 U.S.C. 271(a), (b), and (c). It also alleges, on information and belief, that the defendants amended the application to add the certification despite an objectively high risk of infringing a valid patent.

The prayer asks for judgments of infringement, an order under 35 U.S.C. 271(e)(4)(A) that any FDA approval take effect no earlier than the patent's expiration plus any extensions and exclusivities, preliminary and permanent injunctions that the complaint says should run through any exclusivity, including Orphan Drug Exclusivity, an exceptional-case finding with attorney fees under 35 U.S.C. 285, and costs.

What to watch next

The docket shows summonses issued October 15, 2026, text orders entered October 28 and October 30, 2026 that set hearings, and a status conference minute entry on October 30, 2026. Watch for the defendants' response, any coordination with the related RADICAVA ORS actions in the district, and any narrowing of the asserted claims. The case can end at any time, including by settlement or voluntary dismissal.