BRIEF—Orexo files patent infringement action Sun Pharma

Sweden’s Orexo has filed a patent infringement action in the US District Court for the District of New Jersey against India’s Sun Pharmaceutical Industries and certain of its subsidiaries.

The lawsuit was filed in response to an Abbreviated New Drug Application (ANDA) filed by Sun with the US Food and Drug Administration seeking to market and sell generic versions of Orexo's Zubsolv (buprenorphine and naloxone) sublingual tablets (CIII), in the USA prior to expiration of the patents listed in FDA's Orange Book.

The patents have expiration dates ranging from December 2027 to September 2032.

Since Orexo timely filed a lawsuit against Sun, the FDA is statutorily precluded from approving Sun's ANDA for 30 months, or until a district court decision finds the patents to be invalid or not infringed, whichever occurs first.

The 30-month stay period began as of the date Orexo received the notice letter from Sun advising Orexo of their ANDA filing.