Zydus Cadila said it received tentative approval from the USFDA to market Pimavanserin tablets — a generic form of Acadia Pharmaceuticals’ Nuplazid — in the US.
Tentative approval refers to approval given ahead of patent expiry. The company will be able to start selling the drug only when the patent protection expires.
The compound, as a treatment for hallucinations and delusions associated with Parkinson’s disease psychosis, was patented by Acadia Pharmaceuticals several years ago. Some companies announced plans to bring out a generic version of Nuplazid last year, leading Acadia to file patent suits.
However, in a regulatory filing recently, Acadia had this to say:
“The pimavanserin-specific patent and the Parkinson’s disease psychosis treatment patent provide protection until June 2027 and 2026, respectively. The patent that covers polymorphs of pimavanserin provides protection until June 2028. The patents that cover pimavanserin generically expire in 2021.”
Nuplazid was approved in 2016 to treat hallucinations and delusions associated with Parkinson’s disease psychosis. In October 2017, it received breakthrough therapy designation from the FDA for hallucinations and delusions related to dementia-related psychosis.
Following this, Acadia Pharma, last year, filed a supplemental new drug application (sNDA) for the drug as a treatment for hallucinations and delusions in dementia patients, as distinct from Parkinson’s patients.
The drug is the first and only medication approved by the U.S. Food and Drug Administration for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis.
It is a selective serotonin inverse agonist and antagonist that targets 5-HT2A receptors.
Zydus Cadila said the drug helps lessen symptoms such as seeing or hearing things that are not there (hallucinations) and false beliefs (delusions) in Parkinsons’ patients.
It will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila added.
With this, the group now has 325 approvals and has so far filed over 400 ANDAs.