Swedish drug-maker Meda Pharmaceuticals Inc and India’s Cipla have sued Canadian pharmaceutical company Apotex in the US Federal District Court in Delaware to enforce their patents covering nasal spray Dymista.

The development was in response to Apotex’s filing with the US Food and Drug Administration (FDA), seeking approvals for its generically similar version of Meda’s Dymista (azelastine HCl and fluticasone propionate), prior to the expiration of Dymista patents.

Apotex’s filing involves a patent challenge and Meda’s complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, Meda and Cipla said in a joint note.

The move triggers an automatic stay, preventing the FDA from approving Apotex’s ANDA (abbreviated new drug application) for 30 months from the receipt of the notice, unless ordered otherwise by a district court, the companies said.

In June last year, Cipla and Meda expanded their collaboration in the segment of allergic rhinitis, or allergies affecting the nasal airways.

Patent details

Meda has the global commercial rights on the product, excluding some markets where Cipla would take the lead, the companies had then said without giving details. Meda has exclusive licences to US Patent Nos 8,163,723 and 8,168,620, covering the Dymista composition and its approved uses, which does not expire until 2026, it said.

Meda holds the New Drug Application to manufacture and market Dymista in the US for the treatment of seasonal allergic rhinitis. “Meda will vigorously enforce the Dymista patent rights against Apotex and any other company who challenges these patents”, Jörg-Thomas Dierks, Meda Chief Executive, said in the statement.