PADAGIS ANNOUNCES TWO FIRST-TO-FILE ANDA SUBMISSIONS

ALLEGAN, Mich., June 15, 2023 /PRNewswire/ -- Padagis announced today two first-to-file ANDA submissions. Padagis President, Pam Hoffman, stated "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."

On June 14^th Hikma Pharmaceuticals USA, Inc initiated patent infringement action in the U.S. District Court for the District of Delaware regarding a first-to-file Abbreviated New Drug Application ("ANDA") filed by Padagis for a generic version of Kloxxado® (Naloxone), nasal spray, 8mg. Kloxxado® is  an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.. Annual market sales for Kloxxado® were approximately $16 million in the 12 months ended April 2023 as measured by IQVIA.

Additionally, on June 1^st Evofem Biosciences, Inc initiated patent infringement action in the U.S. District Courts for the District of Delaware and New Jersey regarding a first-to-file ANDA filed by Padagis for a generic version of Phexxi® (Lactic Acid, Citric Acid and Potassium Bitartrate), vaginal gel. Phexxi® is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. Phexxi is not effective for prevention of pregnancy when administered after intercourse. Annual market sales for Phexxi® were approximately $28 million in the 12 months ended April 2023 as measured by IQVIA.

About Padagis

Padagis is dedicated to improving the well-being of patients and consumers by providing high quality, affordable, specialized healthcare products.  The company is a leading provider of extended topical and other specialty pharmaceuticals to its primary markets of the United States and Israel. Padagis employs over 1,300 people worldwide. Visit Padagis online at (http://www.padagis.com).

SOURCE Padagis