US FDA’s First Competitive Generic Therapy Approval Comes With A Twist

10 Aug 2018

Apotex’s potassium chloride oral solution is eligible for 180-day exclusivity under new expedited pathway even though Amneal’s generic referencing same product was approved three weeks earlier; Amneal's continued marketing will not be blocked by Apotex’s exclusivity, which is forfeited if it fails to launch within 75 days.

The US FDA’s first approval under the Competitive Generic Therapy pathway came with a twist – it followed the approval just weeks earlier of a first generic, from a different sponsor, to the same reference product.

On Aug. 8, the agency approved Apotex Inc.’s abbreviated new drug application (ANDA) for potassium chloride oral solution, which...