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Jazz Pharmaceuticals JAZZ, a drug company behind the CBD-based medication Epidiolex, recently filed a lawsuit against Teva Pharmaceutical Industries Ltd TEVA, Apotex, Alkem and several other generic drugmakers alleging patent infringement on the cannabis-derived therapy.
Epidiolex, which won its U.S. Food and Drug Administration (FDA) approval in 2018 and 2020 as the first therapy comprised of an active ingredient derived from cannabis, treats seizures from Lennox-Gastaut Syndrome (“LGS”), Dravet Syndrome (“DS”), and Tuberous Sclerosis Complex (“TSC”), all of which are rare diseases characterized by severe early-onset epilepsy.
What Happened
According to the lawsuit, filed in the U.S. District Court for the District of New Jersey, Jazz accuses generic drugmakers of submitting abbreviated New Drug Applications (ANDAs) to the FDA to market generic versions of Epidiolex.
The company, which relied on the drug through its $7.2 billion buyout of GW Pharmaceuticals PLC- ADR GWPH in 2021, says its patents cover the “composition and method of use of Epidiolex, and methods of treatment using Epidiolex.”
Attempts to develop and market those generics took place “prior to the expiration of one or more” of GW’s patents, per the lawsuit.
Additionally, the patents on the drug run to 2035 and beyond, according to the FDA’s Orange Book. Moreover, Jazz says its FDA regulatory exclusivity protects the product until 2025 and 2027 for certain uses.
The generics makers contend that their proposed copycat medications do not infringe Jazz patents, or that the patents are invalid, reported Fierce Pharma.
According to Jazz’s 3Q 2022 financial results, Epidiolex/Epidyolex net product sales increased 22% to $196.2 million in 3Q22 compared to the same period in 2021.
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