Generic Version of Zetia Likely to Clear FDA Soon. . . .

Mumbai-based Glenmark Pharmaceuticals Ltd. has received tentative approval for a generic 10 mg form of ezetimibe, the chemical name of Schering-Plough's branded Zetia. This, from today's HeartWire -- do go read it all:

. . . .In a press release issued Monday, Glenmark, which is based in Mumbai, India, said this is the first tentative approval granted by the FDA and that the company believes it has "first-to-file" status on ezetimibe, which would give it 180 days of market exclusivity. The tentative approval is for the 10-mg dose. . . .

It just keeps on rainin' -- over in Kenilworth.

UPDATED @ 2:24 pm: A commenter, below, points out that Schering-Plough has sued Glenmark for patent infringement, on the chemical ezetimibe.

I will go verify this, but I believe Glenmark Pharma will still be free to conduct an "at risk" launch, even if the suit isn't resolved, by the time FDA clears Glenmark's ANDA. There is only a relatively short window within which the federal district courts may order a generic competitor that it is not "allowed to take the risk" of launching a competing version -- and thus, arguably be liable for damages to the patent holder (here Schering-Plough). I believe that period is not far from expiry.

I will report back on what I find, right here -- from an amended (March 10, 2008) Answer filed by Glenmark, in the Ezetimibe Patent Litigation (Case No. 07-1334, U.S. Dist. Ct. NJ):

. . . .18. Glenmark Ltd. admits that if ANDA No. 78-560 is approved by the FDA, that Glenmark USA may market and distribute an ezetimibe product in the United States. . . .

135. On information and belief and as discussed in detail earlier in this Answer, the failure of either Magatti, Schering, and / or other Schering individuals subject to Rule 56, to disclose to the PTO during prosecution of the ’751 application that the metabolites of the SCH48461 compound were inherently produced when SCH48461 was administered to mammals (including humans), as described in the ‘048 PCT, was an intentional and knowing act. . . .

238. On October 25, 2006, Abbreviated New Drug Application (“ANDA”) 78-560 was filed with the U.S. Food and Drug Administration (“FDA”) pursuant to 21 U.S.C. § 355(j). ANDA 78-560 seeks FDA approval to market 10 milligram ezetimibe tablets (“the Glenmark Ezetimibe Product”).

239. One or more claims of the ‘721 patent are invalid for double patenting and / or failure to meet one or more of the requirements of patentability set forth in the Patent Statute, inter alia, 35 U.S.C. §§ 101, 102, 103, 112, 116, and 256. . . .

242. The ‘721 patent, and all patents in the ‘721 family of patents, are unenforceable for inequitable conduct before the PTO by Schering, other Schering individuals subject to Rule 56, and Schering’s counsel, and / or failure on the part of Schering, other Schering individuals subject to Rule 56, and Schering’s counsel, to comply with the PTO Duty of Disclosure under Rule 56. . . .

In short, Glenmark is disputing the validity of the Schering-Plough patents -- and intends to market ezetimibe 10 mg "at risk" -- if and when it receives FDA approval to do so.

Stay tuned.