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3 December 2014Americas

Cipla and Meda sue Apotex over Dymista application

Drugs companies Cipla and Meda Pharmaceuticals have sued Canada-based Apotex as they seek to protect the nasal spray Dymista (Azelastine hydrochloride, fluticasone propionate).

The pair took action in response to Apotex’s Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration that sought approval to market a generic version of the drug, used to treat allergies.

Although developed by Cipla, Sweden-based Meda has the rights to commercialise the drug.

In their complaint, which was filed at the US District Court for the District of Delaware, and announced yesterday (December 2), the pair said Apotex’s ANDA would infringe US patent numbers 8,163,723 and 8,168,620, which cover the Dymista composition and its approved uses.

Both patents are not due to expire until 2026.

The complaint, Meda said, was filed within 45 days of receiving Apotex’s notice that it had filed the ANDA.

This triggers an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months, unless ordered otherwise by a district court.

Meda holds the New Drug Application to manufacture and market Dymista in the US to treat seasonal allergic rhinitis.

"Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents,” said Jörg-Thomas Dierks, chief executive at Meda.

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