Business Wire·Nov 9, 2026, 11:47 PM ET

Acadia Pharmaceuticals Comments on Federal Circuit Oral Argument in NUPLAZID® Formulation Patent Appeal

Acadia Pharmaceuticals Inc. reported oral arguments were held before the U.S. Court of Appeals for the Federal Circuit regarding the appeal of a May 2025 district court decision upholding U.S. Patent No. 11,452,721.
The '721 patent covers the NUPLAZID® (pimavanserin) 34 mg capsule formulation.
The oral argument was conducted before a three-judge panel, with a Federal Circuit ruling requiring a majority vote of two judges.
Acadia anticipates a Federal Circuit decision will be issued in the first half of 2027, though no specific timeline is set.
If the district court judgment is upheld, Acadia expects the '721 patent to protect the 34 mg capsule formulation until February 2038.
If the judgment is not upheld, patent protection is expected to extend to October 2030 based on the previously upheld composition of matter patent & associated pediatric exclusivity.
Under the Inflation Reduction Act, NUPLAZID is expected to be subject to a negotiated price taking effect in 2029.
NUPLAZID is an FDA-approved treatment for hallucinations & delusions associated with Parkinson's disease psychosis, approved in April 2016.
Acadia's commercial portfolio includes FDA-approved treatments for Parkinson's disease psychosis & Rett syndrome, with development programs ongoing for Alzheimer's disease psychosis & Lewy body dementia psychosis.