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.

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