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 14th 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 1st 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
