RE:RE:RE:Will the Epidiolex exclusivity doors get kicked wide opensorry s1i, yes, I meant to reference their ANDA filed to the FDA by a global pharma co in Sept 22, 2022 not a 505(b)
The one thing we dont know is if they were they first to file their ANDA and Paragraph IV Certification to the FDA, as a half year head start could be very beneficial in the pharm shark tank.
"If a generic company is the first to file its Abbreviated New Drug Application (ANDA) with a Paragraph IV certification and prevails in the subsequent lawsuit, that generic company is granted a period of market exclusivity of 180 days." https://paragraphfour.com/paragraph-iv-explained/