The complaint

The case is Harmony Biosciences Management, Inc. and Novitium Pharma LLC v. AET Pharma US, Inc., AET Laboratories Private Limited, Alfred E. Tiefenbacher (GmbH & Co. KG), Sandoz Inc., and Sandoz AG, No. 1:26-cv-01191 (D. Del.), filed September 23, 2026, ECF No. 1 (23 pages). It sought a declaratory judgment under 28 U.S.C. 2201 and 35 U.S.C. 271(g) that the defendants' importing, using, offering, or selling the products described in AET's ANDA No. 218892, pitolisant hydrochloride tablets of 4.45 mg and 17.8 mg referencing WAKIX, would infringe one or more claims of U.S. Patent 11,945,788.

What the patent covers

U.S. Patent 11,945,788, titled Process for Preparing Pitolisant Hydrochloride and Solid-State Forms Thereof, issued April 2, 2024. Claim 1 covers a multi-step process for preparing pitolisant or a salt of it: starting from 3-(4-chlorophenyl)-propionic acid, converting it to the acid chloride or anhydride, reducing that to 3-(4-chlorophenyl)-propanol, adding an activating group, and reacting the result with 3-(piperidin-1-yl)propan-1-ol in a solvent with a base to obtain pitolisant, with further optional salt-forming steps. (U.S. Patent 11,945,788 claim 1; Compl. paras. 42 to 44.)

What the lawsuit alleged

The complaint pleads Harmony as the exclusive licensee of the '788 Patent with respect to WAKIX and the holder of NDA No. 211150, and Novitium as the patent's assignee. It alleges, on information and belief, that AET submitted the ANDA, that Sandoz is AET's commercial partner for the ANDA products, and that the pitolisant hydrochloride drug substance for the ANDA products is made by the claimed process. It also describes earlier Delaware cases between Harmony and AET entities on two Orange Book patents for WAKIX, C.A. Nos. 23-1340 and 24-941, which it says were consolidated with C.A. No. 23-1286. Count I sought the declaration of infringement, and the prayer sought an injunction until the patent expires, damages if the products were sold, and attorneys' fees. (Compl. paras. 1 to 3, 42 to 64; Count I; prayer.)

The dismissal

After a stipulation extending the defendants' time to answer (ECF No. 17), the docket shows a notice of voluntary dismissal filed October 26, 2026 (ECF No. 18) and the case closed on October 27, 2026 per that notice. Harmony and Novitium filed a notice under Fed. R. Civ. P. 41(a)(1)(A)(i) voluntarily dismissing the action without prejudice (ECF No. 18).

What to watch next

The case is closed. Watch for any refiled complaint on the '788 Patent against the same ANDA.