Padagis, formerly Perrigo’s generic prescription pharmaceutical business, has announced the launch of a generic version of Narcan naloxone nasal spray for the reversal of opioid overdose. The Padagis generic is the second approved in the US since the FDA’s initial approval of Narcan in 2015. Teva’s version of Narcan was approved by the FDA in April 2019 and was launched in December 2021.
Perrigo filed its ANDA for the naloxone nasal spray in 2018, setting off patent litigation with Opiant Pharmaceuticals and Adapt Pharma (now Emergent Biosolutions). According to the FDA drugs database, the ANDA received tentative approval on December 18, 2020; and according to the Orange Book listing, final approval was issued on June 21, 2022.
Padagis President and CEO Sharon Kochan commented, “The Padagis team has been especially prolific in the last thirty days bringing three important new products to customers and patients who rely on high-quality generic products. The culmination of these launches is a result of years of hard work from our world-class development, manufacturing, and commercial teams and are a further illustration of the depth and breadth of our pipeline. We are particularly proud to be one of only two approved ANDA’s for naloxone nasal spray which is a very important tool in the fight against the opioid epidemic in the United States.”
Read the Padagis press release.
