The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.
Sage Chemical won the
first generic approval
for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.
If patients wanted to take the generic version, they’d need to separately obtain the brand-name Apokyn pen, regulators said.
Sage and its partner TruPharma have since alleged that Supernus has acted unlawfully to delay or block generics to Apokyn, including through its control over the injector pen. While Supernus has filed a motion to dismiss the case, the FTC filed an amicus, or “friend of the court,”
brief
on Monday arguing that “there is a broader public interest in the legal issues this case presents.”
“Competition from cheaper generic versions of branded drugs saves consumers hundreds of billions of dollars per year,” the brief states.
The FTC alleged that Sage has made “almost no sales” on its Apokyn generic in the year since its approval, while patients pay “supracompetitive prices for Apokyn because of Defendants’ anticompetitive scheme.” The agency added that “the exclusion of lower-cost generic drug competition typically causes significant harm to consumers and to competition.”
Meanwhile, brand-name Apokyn sold $75.3 million in 2022, down 24% from the year prior. Supernus
picked up
Apokyn along with Myobloc and Xadago in its $300 million deal for US WorldMeds’ CNS portfolio back in 2020.