Jazz Pharmaceuticals has filed a lawsuit against several other drug makers, alleging patent infringement over attempts to make generic versions of Epidiolex, its FDA-approved cannabis-based oral treatment for epilepsy.
The company said it received notice that Teva Pharmaceuticals; Padagis; Apotex; API Pharma Tech and InvaGen Pharmaceuticals; Lupin Limited; Taro Pharmaceutical Industries; Zenara Pharma Private Limited and Biophore Pharma; MSN Laboratories and MSN Pharmaceuticals; Alkem Laboratories; and Ascent Pharmaceuticals had filed abbreviated new drug applications (ANDA) with the FDA.
On January 3, 2023, Jazz filed a patent infringement suit against the companies in the United States District Court for the District of New Jersey.
"The complaint alleges that by filing their ANDAs, the ANDA filers have infringed certain of the company’s Orange Book listed patents, and seeks an order that the effective date of FDA approval of the ANDAs shall be a date no earlier than the expiration of the last to expire of the asserted patents," the company wrote in an SEC filing. "As a result of this lawsuit, a stay of approval of up to 30 months will be imposed by FDA on the ANDA Filers’ ANDAs.
Jazz said Epidiolex also has Orphan Drug Exclusivity for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older through September 28, 2025 and for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients between 1 and 2 years of age and for the treatment of seizures associated with tuberous sclerosis complex through July 31, 2027.