First to File Paragraph IV generic exclusivity for Eszopiclone, Erlotinib, Lanthanum Carbonate, Doxycycline: Mylan confirmed patent litigations

Pharma giant Mylan confirmed (in a press release Here) that Mylan and/or a subsidiary have been sued in connection with four separate "first-to-file" Paragraph IV Abbreviated New Drug Applications (ANDA) filed with the U.S. Food and Drug Administration (FDA).
1. Eszopiclone Tablets, 1 mg, 2 mg and 3 mg: Mylan and Alphapharm were sued by innovator Sepracor Inc. in the U.S. District Court of New Jersey in connection with the ANDA filing for Eszopiclone Tablets. Eszopiclone Tablets are the generic version of Sepracor's insomnia treatment Lunesta® Tablets, which had approximately $796 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health. (IP Pharma doc earlier review Here)
2.Erlotinib Hydrochloride (HCl) 25 mg, 100 mg and 150 mg Tablets: Mylan was sued by innovators OSI Pharma, Pfizer and Genentechin the U.S. District Court in Delaware in connection with the ANDA filing for Erlotinib Hydrochloride (HCl) Tablets, 25 mg, 100 mg and 150 mg. Erlotinib HCl Tablets are the generic version of OSI Pharmaceuticals' lung cancer treatment Tarceva® Tablets, which had approximately $492 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health. (IP Pharma doc earlier review Here)
3. Lanthanum Carbonate Chewable Tablets, 500 mg, 750 mg and 1000 mg: Mylan and Matrix were sued by innovators Shire (as reported by IP Pharma doc Here and Here) in the U.S. District Court for the Southern District of New York in connection with the ANDA filing for Lanthanum Carbonate Chewable Tablets, 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets are the generic version of Shire's kidney disease treatment Fosrenol®, which had approximately $108 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health.
4. Doxycycline Delayed-release (DR) Capsules USP, 40 mg: Mylan was sued by innovator Galderma Lab, The Research Foundation of the State University of New York and New York University in the U.S. District Court of Delaware in connection with the ANDA filing for Doxycycline Delayed-release (DR) Capsules USP, 40 mg. Doxycycline DR Capsules are the generic version of Galderma's adult rosacea treatment Oracea® Capsules, which had approximately $82 million in U.S. sales for the twelve months ending Dec. 31, 2008, according to IMS Health. (IP Pharma doc earlier review Here)

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 has 118 ANDAs pending FDA approval, 33 of which are potential first-to-file opportunities.