Sweden-based drug firm Meda Pharmaceuticals Inc and Cipla Ltd have “sued” Apotex Inc and Apotex Corp in the Federal District Court in Delaware, US to enforce patents of its allergy drug ‘Dymista’.
Cipla has sued Apotex Inc and Apotex Corp “in response to Apotex’s submission to the US FDA of an abbreviated new drug application (ANDA), and accompanying Paragraph IV certification, seeking approval to market a generic version of Meda’s ‘Dymista’ prior to expiration of the ‘Dymista’ patents.
In June 2013, Cipla granted the global commercialisation rights for ‘Dymista’ to Meda AB except for certain geographies.
The Complaint was filed within 45 days of receiving Apotex’s Paragraph IV certification notice, thus triggering an automatic stay preventing the FDA from approving Apotex’s ANDA for 30 months from receipt of the notice, unless ordered otherwise by a district court.
Meda has the exclusive licenses 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.
Meda holds the New Drug Application (NDA) to manufacture and market Dymista in the US for the treatment of seasonal allergic rhinitis.
Meda and Cipla are jointly represented by attorneys from Sterne, Kessler, Goldstein & Fox PLLC and Ashby & Geddes, PA.