Shionogi Inc. filed Shionogi Inc. v. Zydus Pharmaceuticals (USA) Inc., No. 2:26-cv-12063, in the District of New Jersey on September 14, 2026. The complaint also names Zydus Lifesciences Limited and Zydus Lifesciences Global FZE as defendants.
What the complaint alleges
The complaint alleges that Zydus submitted ANDA 220849 for a proposed edaravone oral suspension at a concentration of 105 mg/5 mL, identifying RADICAVA ORS as the reference listed drug. Shionogi asserts U.S. Patent 12,599,586, which the complaint identifies as Edaravone suspension for oral administration.
Count 1 alleges infringement of the '586 patent. Paragraph 47 alleges that the proposed product infringes one or more claims, including at least independent claim 1, literally or under the doctrine of equivalents. These are allegations in the complaint.
Context from the complaint
Paragraph 3 lists eighteen related infringement actions involving RADICAVA ORS pending in the District of New Jersey, including In re Radicava ORS, No. 25-03326, and two earlier Shionogi suits against Zydus, No. 25-18032 (filed November 29, 2025) and No. 26-06619 (filed June 5, 2026). Paragraph 4 says that, as announced December 22, 2025, Shionogi agreed to acquire the global RADICAVA ORS business from Tanabe Pharma Corporation, formerly Mitsubishi Tanabe Pharma Corporation, and that it took ownership of the U.S. assets, including the NDA and its Orange Book-listed patents, as of April 1, 2026. Paragraph 5 says Tanabe intends to move under Federal Rule of Civil Procedure 25(c) to substitute Shionogi as plaintiff.
Paragraph 38 alleges that the '586 patent issued on April 14, 2026, and paragraph 51 alleges that Zydus amended ANDA 220849 to add a Paragraph IV certification for it after learning of the patent. Paragraphs 12 through 14 allege that FDA granted RADICAVA ORS seven years of orphan drug exclusivity on March 28, 2024, expiring May 12, 2029, and prayer D asks for an injunction that runs through any exclusivity to which Shionogi is or becomes entitled, "including Orphan Drug Exclusivity."
What relief is requested
In paragraph C of its prayer for relief, Shionogi asks the court to order that any FDA approval of ANDA 220849 take effect no earlier than expiration of the patent, including any patent term extensions or adjustments and additional exclusivity to which Shionogi is or becomes entitled. It also asks for judgments of infringement (prayers A and B), a preliminary and permanent injunction (prayer D), and an exceptional-case finding with attorneys' fees under 35 U.S.C. 285 (prayer E).
What to watch next
Watch for consolidation or coordination with In re Radicava ORS, No. 25-03326, the Rule 25(c) substitution motions, Zydus's answer, and any narrowing of the asserted claims.