Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) today announced that Alvogen US received a decision from the United States District Court for the District of Delaware that Alvogen prevailed in challenging US Patent No. 8,784,888, the only remaining patent in suit, covering UCERIS (Budesonide ER) tablets marketed as a brand product by Valeant International Pharmaceuticals (“Valeant”). This is one of the products under strategic alliance between Alvogen US and Lotus. The court determined that the asserted claims of this patent are not infringed, and therefore Alvogen US and Lotus will proceed with ANDA related preparations. Meanwhile, the Company is prepared if Valeant appeals.
Alvogen US was sued in February 2015 due to the PIV challenge of UCERIS. Valeant obtained the rights to UCERIS via its acquisition of Salix Pharmaceuticals in April 2015.
Based on the decision, US Food and Drug Administration (FDA) may grant Alvogen US and, subsequently, Lotus the ANDA approval of Budesonide ER, subject to the appealing of Valeant, after the 180-day generic exclusivity of the first-to-file (FTF) either lapses or is otherwise forfeited, in this case Teva/Actavis. IMS data showed that UCERIS enjoys market size of approximately US$200 million in the past 12 months and there are currently no generic competitors in the market.