Takeda and Lundbeck take more patent action over Trintellix

Drug makers Takeda and Lundbeck have filed a patent infringement lawsuit over anti-depressant medication Trintellix (vortioxetine hydrobromide), less than a month after launching similar claims.

On Thursday, June 7, the companies sued India-based MSN Laboratories after it sought approval from the US Food and Drug Administration (FDA) to sell a generic version of Trintellix.

Takeda and Lundbeck filed the suit in the US District Court for the District of Delaware, where they also took action against generic drug company Lupin on May 21 over the same drug.

The disputed patent—US number 9,861,630—is assigned to Lundbeck, a Danish company. Japan-based Takeda owns New Drug Application No. 204447 for Trintellix tablets in 5 mg, 10 mg, 15 mg and 20 mg dosage strengths.

According to the lawsuit, MSN has sent two letters to Takeda and Lundbeck notifying them of the Abbreviated New Drug Application (ANDA), with the most recent being issued on April 23.

Takeda and Lundbeck said the ANDA will directly infringe the ‘630 patent. They have asked for a permanent injunction against MSN and an order that the effective date of any FDA approval of the application be no earlier than the expiration date of the patent.

The companies announced in May that the FDA had granted a supplemental new drug application for Trintellix, which was originally approved in the US in September 2013. The drug has been given the green light in nearly 80 countries and is currently available in more than 60.

In the first quarter of this year, Trintellix and Brintellix (the name for the drug outside the US)  achieved revenues of DKK 467 million ($73.4 million), a 25% increase compared to the same period in 2017.

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