Orexo files US patent infringement law suit against Actavis for Abstral

Sweden-based pharma company Orexo (STO: ORX) has filed a patent infringement law suit in the US District Court for New Jersey against Ireland-headquartered generics major Actavis (NYSE: ACT).

The law suit was prompted by Actavis’ filing of an Abbreviated New Drug Application for Abstral (fentanyl) sublingual tablets in the USA prior to the expiration of Orexo’s US patents for Abstral, as listed in the FDA’s Orange Book. US Patents 6,759,059, 6,761,910 and 7,910,132 are not due to expire until September 2019, the company said.

Orexo’s law suit means the FDA is statutorily precluded from approving Actavis’ ANDA for 30 months, or until a district court decision finding the patents invalid or not infringed.