Michael Vi /
22 February 2022Americas

Janssen seeks to halt generic schizophrenia drug

Johnson & Johnson unit Janssen Pharmaceuticals has filed a suit against Intas Pharmaceuticals, seeking to block the India-based drugmaker from launching a generic version of schizophrenia drug Invega Sustenna (paliperidone palmitate).

In a suit filed February 16 at the US District Court for the District of New Jersey, Janssen accused Intas and its subsidiaries of infringing US patent number 9,439,906, called “Dosing regimen associated with long acting injectable paliperidone esters”.

The complaint stems from the filing of an Abbreviated New Drug Application (ANDA) by Intas’ subsidiary Accord Healthcare to the Food and Drug Administration, seeking approval to market a generic version of Invega Sustenna.

The ANDA includes a paragraph IV certification that the claims of the ‘906 patent are invalid, unenforceable, and/or not infringed.

“Defendants’ generic paliperidone palmitate extended-release injectable suspension products are specifically designed for use in a manner that infringes claims 1-21 of the ‘906 patent,” said the suit.

Invega Sustenna is a blockbuster drug. J&J’s portfolio of schizophrenia injections—Invega Sustenna/Xeplion/Invega Trinza/Trevicta—made $4 billion in sales in 2021.

“Plaintiffs will be irreparably harmed by defendants’ infringing activities unless those activities are enjoined by this court,” said Janssen’s suit.

Janssen has asked the court to find that Intas’ has infringed the ‘906 patent and issue and order holding that the effective date of any approval of the ANDA is a date that is not earlier than the expiration date of the ‘906 patent. The patent expires in 2031.

Janssen has also requested that the court issue an injunction and issue an order for costs. It has asked for damages where Intas imports its generic into the US, before the expiration of the patent.

The lawsuit against Intas comes just months after Janssen’s successful attempt to halt Teva’s generic version of the schizophrenia drug.

In November 2021, after a two-week bench trial, the New Jersey court found in favour of Janssen, rejecting Teva’s claims and holding that the ‘906 patent was not invalid.

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