Pharma companies routinely sue generics makers for alleged patent infringement with their proposed copycats. But the fight over Jazz Pharmaceuticals' Epidiolex marks a more unique fight against pending generic competition.
Jazz is suing Teva, Apotex, Alkem and a few other generic drugmakers for alleged infringement on the cannabis-derived therapy, the company said in a Securities and Exchange Commission filing. The drug won its FDA approval back in 2018 as the first therapy comprised of an active ingredient derived from marijuana.
Jazz got its hands on the drug through its $7.2 billion buyout of GW Pharmaceuticals back in 2021. Epidiolex is approved to treat seizures from Lennox-Gastaut syndrome, tuberous sclerosis complex or Dravet syndrome.
The company says its patents cover the "composition and method of use of Epidiolex, and methods of treatment using Epidiolex." The patents on the drug run to 2035 and beyond, according to the FDA's Orange Book.
Further, Jazz says its FDA regulatory exclusivity protects the product until 2025 and 2027 for certain uses.
For their part, the generics makers contend that their proposed copycats wouldn't infringe Jazz patents, or that the patents are invalid.
Last March, Jazz dropped $100 million on a 60,000-square-foot facility to boost manufacturing of Epiodiolex and nabiximols, a cannabis-derived spray that’s been approved in the EU for MS spasticity for more than a decade. That drug flopped its U.S. phase 3 trial, failing to improve lower-limb muscle tone as measured by the Modified Ashworth Scale. The spray, known as Sativex in Europe, garnered $13 million in 2021 sales.
As for Epidiolex, the drug is on a growth streak, generating nearly $530 million in the first 9 months of 2022.