Perrigo said that Adapt Pharma and Opiant Pharmaceuticals have initiated patent litigation in the United States District Court for the District of New Jersey in regards to Perrigo’s recently filed ANDA for a generic version of Narcan naloxone nasal spray for the treatment of opioid overdose.
Adapt Pharma licensed naloxone nasal spray from Opiant (then called Lightlake Therapeutics) in December 2014. Adapt has now been acquired by Emergent BioSolutions.
The 4 mg dose Narcan nasal spray was approved by the FDA in November 2015, and a 2 mg dose version of Narcan was approved in January 2017. Perrigo said that its ANDA is for a 4 mg dose nasal spray.
According to a September 19, 2018 filing with the Securities and Exchange Commission, Opiant Pharmaceuticals received notice of the filing from Perrigo on September 14. The patents involved are US patents nos. 9,211,253, 9,561,177, 9,629,965, and 9,775,838
Perrigo Executive VP and President of Rx Pharmaceuticals John Wesolowski commented, “This filing is another example of the diligent work done by our skilled R&D, operations and legal teams to develop new extended topical generic products that lower the cost of healthcare.”
Read the Perrigo press release.