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

businesswire.com
ACAD The article discusses an oral argument in a patent appeal for NUPLAZID®, a key drug for Acadia. The outcome of this appeal could impact the company's intellectual property and future revenue streams, but the article does not provide a clear indication of the likely outcome or its immediate financial implications.

Acadia Pharmaceuticals Comments on Federal Circuit Oral Argument in NUPLAZID® Formulation Patent Appeal SAN DIEGO--( BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today reported that oral arguments were held before the U.S. Court of Appeals for the Federal Circuit in the appeal of the U.S. District Court for the District of Delaware’s May 2025 decision upholding Acadia’s U.S. Patent No. 11,452,721 (the ‘721 patent), which covers the NUPLAZID® (pimavanserin) 34 mg capsule formulation.

“We continue to believe in the strength of our position on the NUPLAZID formulation patent, on which the Federal Circuit heard oral arguments today,” said Catherine Owen Adams, Chief Executive Officer of Acadia. “Acadia believes the district court’s decision is supported by the facts established at trial and by applicable law. The trial court decided key issues of fact after hearing detailed testimony from experts. Such factual findings should receive deference from the appeals court.”

Today’s oral argument was heard by a three-judge panel, and a decision by the Federal Circuit requires a majority of two of the three judges. While there is no set timeline for a ruling, Acadia expects a decision in the first half of 2027.

If the district court’s judgment is upheld, Acadia expects the ‘721 patent to provide protection for the NUPLAZID 34 milligram capsule formulation until February 2038. If it is not upheld, Acadia expects patent protection to extend to October 2030, based on pimavanserin’s composition of matter patent, which was previously upheld by the Federal Circuit, and associated pediatric exclusivity.

As a reminder, under the Inflation Reduction Act, Acadia expects NUPLAZID to be subject to a negotiated price taking effect in 2029.

About NUPLAZID®

Pimavanserin is a selective serotonin inverse agonist and antagonist preferentially targeting 5-HT2A receptors. These receptors are thought to play an important role in neuropsychiatric disorders. In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors. Pimavanserin was approved for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis by the U.S. Food and Drug Administration in April 2016 under the trade name NUPLAZID.

About Acadia Pharmaceuticals

Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson’s disease psychosis and Rett syndrome. We are developing the next wave of therapeutic advancements with a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer’s disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs that address other underserved patient needs. At Acadia, we’re here to be their difference. For more information, visit us at acadia.com and follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential,” “continue” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about: (i) our comments on the Federal Circuit oral argument; (ii) the strength of the NUPLAZID ‘721 patent; (iii) the strength of the trial court’s decision, including its findings of fact and the anticipated treatment of those findings on appeal; (iv) the expected scope and duration of protection for NUPLAZID under the composition of matter patent, associated pediatric exclusivity and the 34 mg capsule formulation patent, including under alternative outcomes of the appeal; (v) the anticipated timing of the Federal Circuit decision; and (vi) the anticipated application of negotiated pricing to NUPLAZID under the Inflation Reduction Act, including the expected effective date of such pricing. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Such risks, uncertainties and other factors include, but are not limited to: our ability to maintain, protect and enhance our intellectual property; the outcome and timing of the pending appeal and other existing and potential future lawsuits challenging our intellectual property; uncertainties concerning the selection of NUPLAZID for negotiated pricing under the Inflation Reduction Act and the implementation, timing and impact of such pricing, including changes in applicable laws, regulations or their interpretation; uncertainties inherent in drug development, including the timing and results of clinical trials, our ability to obtain regulatory approvals and whether our development programs will result in safe and effective treatments that provide the anticipated patient benefits; and our ability to remain in compliance with applicable laws and regulations. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-Q for the quarter ended September 30, 2026, filed on November 5, 2026, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law.