Ranbaxy Foils Mylan's Challenge To Valsartan Exclusivity

Law360, Washington (January 2, 2013, 3:28 PM EST) -- A Washington federal judge on Thursday tossed Mylan Pharmaceuticals Inc.'s suit against the U.S. Food and Drug Administration that attempted to gain marketing approval for its generic hypertension drug valsartan, saying Ranbaxy Laboratories Ltd.'s first-to-file exclusivity for the generic remains intact.

Although Ranbaxy received its tentative FDA approval for its generic version of valsartan nearly four months after the deadline, U.S. District Judge John D. Bates determined the delay was understandable, as the approval requirements changed within the 30-month period in which Ranbaxy had to obtain...
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Case Information

Case Title

MYLAN LABORATORIES LIMITED et al v. FOOD AND DRUG ADMINISTRATION et al


Case Number

1:12-cv-01637

Court

District Of Columbia

Nature of Suit

Other Statutory Actions

Judge

John D. Bates

Date Filed

October 2, 2012

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