The Federal Trade Commission has jumped into a commercial dispute making its way through federal court, siding with two companies trying to break into the market for an expensive Parkinson’s disease drug.
Supernus Pharmaceuticals currently sells the branded medicine, called Apokyn, which cost Medicare close to $100,000 per patient in 2020, according to the FTC. Sage Chemical and partner TruPharma won Food and Drug Administration approval more than a year ago for a cheaper generic version, but they say Supernus and its partners have blocked their ability to sell it.
At issue is the Apokyn Pen, a reusable injector needed to dispense the medicine through cartridges made either by Supernus or its generic competition. Sage and TruPharma allege Supernus blocked their efforts to have the pen maker manufacture a version for them and then used its position as the only provider of the pen to spur pharmacies to rescind orders for their cheaper generic option.
The case could have implications for other drug-device combinations on the market and may reflect the FTC’s increased scrutiny of the pharmaceutical industry in general. Expert advisers last year warned the FTC that some drugmakers were gaining unfair market power.
“Because the strategies alleged here are similar to strategies used by other branded pharmaceutical companies to block generic competition, there is a broader public interest in the legal issues this case presents,” the FTC said in the brief filed Monday with the U.S. District Court in Delaware.
Apokyn hasn’t had any exclusive marketing rights or patent protection since 2011, but it has steadily become more costly. In the last five years, the price has risen by more than 30%, according to the FTC’s amicus brief