Like Glenmark, Mylan Now Seeks FDA Nod -- To Sell Generic Version Of Zetia® In US

First it was Glenmark trying to put Zetia^® "on ice" -- now (as of May 25, 2010, when it filed an ANDA with the FDA for a generic version of ezetimibe), Mylan Labs has laced up its hockey-skates, as well. On June 10, 2010, a subsidiary of New Merck, on the legacy Schering-Plough side of the house, filed for a re-issue patent on its so-called '721 patent -- one of the patents covering ezetimibe, the chemical compound name for Zetia. Shortly before that, Mylan had sent Merck a "poison pen" letter, saying it was seeking approval to sell a generic version of Zetia. That led Merck to file a patent infringement suit, to create a 30 month automatic stay on Mylan's U.S. market launch.

This patent suit is pending in -- of all places -- the Northern District of West Virginia (H/T Patent Docs blog -- for the lead). It looks as though New Merck was interested in bringing this case where a particularly-able federal judge sits, on patent matters -- in Clarksburg, West Virginia. The judge is Irene M. Keeley, who has also been assigned a current piece of Pfizer drug-patent litigation, also brought against Mylan.

Just a snippet from PatentDocs, then:

. . . .Infringement of U.S. Patent Nos. RE37,721 ("Hydroxy-substituted Azetidinone Compounds Useful as Hypocholesterolemic Agents," issued May 8, 2002) and 5,846,966 ("Combinations of Hydroxy-Substituted Azetidinone Compounds and HMG CoA Reductase Inhibitors," issued December 8, 1998) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Plaintiffs' Zetia® (ezetimibe, used to treat elevated cholesterol levels). . . .

And so -- as of December 2009, Glenmark was angling its way toward a US market launch for a generic version of Zetia. The statutory 30 month stay on US market launch -- created by New Merck's filing of a patent suit in opposition -- as to Glenmark, at least -- expired back in October of 2009. Thus, there may ultimately be at least two generic version of Zetia, before too long. We'll keep you posted.