Quarterly report pursuant to Section 13 or 15(d)

Subsequent Event

Subsequent Event
3 Months Ended
Mar. 31, 2022
Subsequent Event.  
Subsequent Event

NOTE 21. Subsequent Event

On May 2, 2022, the Company filed a complaint against Padagis Israel Pharmaceuticals Ltd. (F/K/A Perrigo Israel Pharmaceuticals Ltd.) (“Padagis”) alleging infringement of certain patents covering Zilxi® (the “Zilxi® Patents”), which are included among the proprietary rights to Zilxi® that were acquired pursuant to the VYNE Product Aquisition. This litigation was initiated following the submission by Padagis, in accordance with the procedures set out in the Hatch-Waxman Act, of an Abbreviated New Drug Application (“ANDA”). The ANDA seeks approval to market a generic version of Zilxi® prior to the expiration of the Zilxi® Patents and alleges that the Zilxi® Patents are invalid. Padagis is subject to a 30-month stay which prevents Padagis from selling a generic version. The stay is set to expire on October 6, 2024. Journey is seeking, among other relief, an order that the effective date of any FDA approval of Padagis’ ANDA be no earlier than the expiration of the patents listed in the Orange Book, the latest of which expires on October 1, 2030, and such further and other relief as the court may deem appropriate. Journey cannot make any predictions about the final outcome of this matter or the timing thereof.