FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER