FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Oct. 19, 2005--Andrx Corporation (Nasdaq:ADRX) (“Andrx” or “Company”) today announced that it has a pending abbreviated new drug application (“ANDA”) with the United States Food and Drug Administration (“FDA”) for generic versions of Cardizem(R) LA (diltiazem HCl extended-release tablets), 120mg, 180mg, 240mg, 300mg, 360mg and 420mg strengths. Andrx initially filed its ANDA for the 420mg strength on April 25, 2005, with a Paragraph IV certification and notification to the patent holder. On August 10, 2005, Biovail Laboratories Int’l SRL. (“Biovail”), which is the holder of the New Drug Application for Cardizem LA, initiated a patent infringement lawsuit against the Company for the 420mg strength in the U.S. District Court for the District of Delaware. On August 30, 2005, Andrx amended its initial ANDA submission to include the 120mg, 180mg, 240mg, 300mg and 360mg strengths, along with a related Paragraph IV certification and notice letter. On October 14, 2005, Biovail initiated a patent infringement lawsuit on the remaining strengths. Andrx believes that it may have been the first ANDA applicant with a Paragraph IV certification for each of the six strengths, and accordingly may be entitled to 180 days of market exclusivity under the Hatch Waxman Amendments.
