Supernus confirms ONAPGO exclusivity and seeks a second supplier

Supernus ($SUPN) said the FDA has recognized orphan-drug exclusivity for ONAPGO, its apomorphine infusion treatment for motor fluctuations in adults with advanced Parkinson's disease. The seven-year protection period runs from the medicine's original approval on February 3, 2025. The announcement therefore confirms protection tied to that earlier approval rather than starting a fresh seven-year period.

The company also submitted a supplemental application seeking approval of a second ONAPGO supplier and continues to anticipate a potential decision by mid-2027. The additional supplier could support more reliable availability after supply problems earlier in the year, while exclusivity helps protect the product's commercial position. The manufacturing change still requires regulatory approval: submitting the application does not establish that the additional supplier is approved or that the expected decision timetable will be met.

Sources:

• GlobeNewswire