Mylan, a generic pharmaceutical company, has announced that it and/or a subsidiary has been sued in connection with four separate first-to-file abbreviated new drug applications filed with the FDA.
Mylan and Alphapharm were sued by Sepracor in the US District Court of New Jersey in connection with the abbreviated new drug application (ANDA) filing for eszopiclone tablets, 1mg, 2mg and 3mg. Eszopiclone tablets are the generic version of Sepracor’s insomnia treatment Lunesta tablets.
Mylan Pharmaceuticals was sued by Osi Pharmaceuticals, Pfizer and Genentech in the US District Court in Delaware in connection with the ANDA filing for erlotinib hydrochloride tablets, 25mg, 100mg and 150mg. Erlotinib hydrochloride tablets are the generic version of Osi Pharmaceuticals’s lung cancer treatment Tarceva tablets.
Mylan, Mylan Pharmaceuticals and Matrix Laboratories, in which Mylan owns a majority interest, were sued by Shire Canada, Shire International Licensing and Shire US in the US District Court of New York in connection with the ANDA filing for lanthanum carbonate chewable tablets, 500mg, 750mg and 1,000mg. Lanthanum carbonate chewable tablets are the generic version of Shire’s kidney disease treatment Fosrenol.
Mylan Pharmaceuticals was sued by Galderma Laboratories Inc, Galderma Laboratories LP, The Research Foundation of the State University of New York and New York University in the US District Court of Delaware in connection with the ANDA filing for doxycycline delayed-release (DR) capsules USP, 40mg. Doxycycline DR capsules are the generic version of Galderma’s adult rosacea treatment Oracea capsules.
Mylan believes it is among the first companies to have filed substantially complete ANDAs containing a Paragraph IV certification for three of these products and expects to be awarded 180 days of shared marketing exclusivity once final approvals are obtained. With Doxycycline DR capsules, Mylan believes it could have sole marketing exclusivity for the 180-day period. Currently, Mylan said that it has 118 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.