RE:I’ll help you out on the when. alleysome, dont be surprised if one of these generic Epidiolex suitors beats the 30 month stay through an FDA orange book patent challenge.
Also dont be surprised if a similiar drug appears in Brazil through Verdemed
Jazz (GW) faced the same music with Avadel's Lumryz drug, lost that infringement lawsuit, and decided its best course of action was to sue the FDA.
Not the best way to make friends with those who hold the ultimate hammer, and I expect no different with Epidiolex now that previous case law has set precedent and the generic ANDA filers have made their intentions known through their Paragraph IV certifications!
"The notices from the ANDA Filers each included a “paragraph IV certification” with respect to certain of the Company’s patents listed in FDA’s Orange Book for Epidiolex on the date of the receipt of the notice. The listed patents relate generally to the composition and method of use of Epidiolex, and methods of treatment using Epidiolex. A paragraph IV certification is a certification by a generic applicant that alleges that patents covering the branded product are invalid, unenforceable, and/or will not be infringed by the manufacture, use or sale of the generic product."