Lundbeck and Takeda take on Lupin over anti-depressant ANDA

Pharmaceutical companies Lundbeck and Takeda have sued generic drug producer Lupin for infringing a patent directed to anti-depressant medication Trintellix (vortioxetine hydrobromide).

The plaintiffs, which jointly market the treatment, filed their complaint at the US District Court for the District of Delaware on Monday, May 21.

It comes after Lupin filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking to sell generic versions of Trintellix.

Lundbeck and Takeda said the ANDA infringes US patent number 9,861,630, which is assigned to Danish company Lundbeck. The US Patent and Trademark Office issued the patent in January 2018.

Takeda USA holds New Drug Application No. 204447 for Trintellix tablets in 5 mg, 10 mg, 15 mg and 20 mg dosages.

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.

According to the lawsuit, the drug is “an inhibitor of serotonin (5-HT) reuptake, an agonist at 5- HT1A receptors, a partial agonist at 5-HT1B receptors, and an antagonist at 5-HT3, 5-HT1D and 5-HT7 receptors”.

“It is considered to be the first and only drug with this combination of pharmacodynamic activity. It represents a major advancement in the treatment of depression,” the suit claimed.

The lawsuit is not the first between the parties in relation to this drug.

On January 12, just three days after the ‘630 patent was issued, Lundbeck and Takeda filed similar patent infringement claims against Lupin, on that occasion over US patent numbers 8,722,684; 8,969,355; and 9,227,946.

In that lawsuit, and in this one, the companies asked for damages, attorneys’ fees, a permanent injunction, and for any FDA approval date of the ANDA to become effective only after the patents have expired.

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