Janssen sues Mylan to block generic of schizophrenia drug
A Johnson & Johnson (J&J) company, Janssen Pharmaceuticals, is seeking a court order blocking Mylan from making copies of its schizophrenia treatment, Invega Trinza, until its patent expires in 2036.
Last month, Mylan submitted an Abbreviated New Drug Application to the US Food and Drug Administration seeking approval to market a generic version of the treatment before the expiration of the patent, US number 10,143,693.
According to the complaint filed Wednesday, September 23, in a federal court in Trenton, New Jersey, Janssen has alleged that Mylan’s proposed generic version of an extended-release injectable treatment for schizophrenia infringes its existing patent.
The company has also requested cash compensation if copies are made, stating in its complaint that, “If Mylan engages in the commercial manufacture, use, offer for sale, sale, and/or importation into the United States of the proposed generic versions of JPI’s Invega Trinza brand products identified in this complaint prior to the expiration of the ’693 patent,” it would demand a “judgment awarding damages…. resulting from such infringement with interest”.
Trinza is a quarterly injectable of Invega Sustenna, which is dosed monthly. According to the FDA Orange Book, Invega Sustenna and Trinza had combined US sales of $1.12 billion during the first half of 2020.
Earlier this year, the City of Baltimore sued Janssen for “unlawfully” delaying generic competition to Zytiga, its branded cancer medication.
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