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Acadia Pharmaceuticals (NASDAQ: ACAD) announced that the U.S. Court of Appeals has upheld the validity of its patent for Nuplazid, a key treatment for hallucinations and delusions linked to Parkinson’s disease psychosis. This decision reaffirms a prior ruling from the U.S. District Court of Delaware in December 2023, solidifying Acadia’s position in an ongoing legal dispute with Indian generics maker MSN Laboratories.
The appellate court determined that the contested patent remains valid, citing legal precedent that prevents later-filed patent claims from invalidating earlier ones when both share the same priority date. This ruling ensures patent protection for Nuplazid’s composition of matter until at least 2030.
“We are gratified that the U.S. Federal Appeals Court has affirmed the lower court’s ruling in favor of our composition of matter patent for Nuplazid,” said Acadia CEO Catherine Owen Adams. “This decision, coupled with a favorable ruling on our formulation patent, provides extended protection for our 34 mg capsule formulation through 2038.”
Nuplazid received FDA approval in 2016 and remains the only treatment specifically approved in the U.S. for Parkinson’s disease psychosis. The ruling marks a major win for Acadia in its broader effort to defend Nuplazid against generic competition, including legal challenges from Aurobindo Pharma and other manufacturers.
The confirmation of both composition and formulation patents significantly enhances Acadia’s intellectual property position, supporting its commercial exclusivity for Nuplazid over the next decade. As generic pressure increases in the pharmaceutical market, strong patent defense remains crucial for companies like Acadia to protect innovation and maintain market share.
This development strengthens Acadia’s revenue outlook and provides investors with greater clarity on the long-term viability of one of its flagship therapies.
