Padagis announced two recent ANDA submissions, including an ANDA for a generic version of Hikma’s Kloxxado naloxone nasal spray for the reversal of opioid overdose. Kloxxado, which delivers an 8 mg dose of naloxone compared to a 4 mg dose for Narcan nasal spray, was approved by the FDA in April 2021. Padagis launched a generic version of Narcan in the US in June 2022.
According to Padagis, Hikma filed a patent infringement suit in the US District Court for the District of Delaware on June 14, 2023 after receiving notification of the ANDA submission.
Padagis President Pam Hoffman commented, “The investments in our pipeline made by Padagis since our inception have begun to bear fruit. Two first-to-file ANDA submissions speak to the innovation and execution capabilities of the Padagis team. Most importantly, these achievements are the embodiment of our mission to bring high-quality, affordable products to our customers and patients.”
Read the Padagis press release.
