Shire Sues to Block Par Pharma’s Generic Adderall XR

Par Pharmaceutical is facing a patent infringement lawsuit over its Paragraph IV ANDA against Shire’s ADHD therapy Adderall XR.

Shire wants Par barred from generic Adderall XR (amphetamine, dextroamphetamine mixed salt) approval until the two patents in question — ’096 and ‘148 — lose their protection, according to the complaint filed Feb. 26 in U.S. district court in New Jersey.

Thanks to pediatric exclusivity, the two patents don’t run out until April 2019, according to the Orange Book.

Shire received word of the ANDA filing in a Jan. 14 notice, according to the lawsuit, Shire LLC v. Par Pharmaceutical, Inc.

The Kentucky-based brandmaker reported $383 million in sales for Adderall XR in 2014, along with $28.9 million in royalty payments for authorized generic versions licensed by Teva and Barr. The FDA also lists a third Adderall generic from Actavis that is not an authorized version.

Par did not respond to a request for comment by press time. — Bryan Koenig