Vanda Pharmaceuticals (VNDA) announced that the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. District Court for the District of Delaware's decision that West Ward Pharmaceuticals, a subsidiary of Hikma Pharmaceuticals (HKMPY), infringed Vanda's U.S. Patent number 8,586,610 for Fanapt. The '610 Patent is set to expire November 2, 2027.
GlaxoSmithKline (GSK) has won an additional reprieve for its Advair lung drug after U.S. regulators demanded Hikma Pharmaceuticals (HKMPY) conduct a further clinical study evaluating the generic version of the drug, Reuters reports, citing Hikma. The firm, along with partner Vectura (VEGPF), expects to submit a response to the FDA with new clinical data in 2019 meaning potential approval and launch of the generic medication could come in 2020 if all goes according to plan. Reference Link