Apotex Receives Final Approval for Ofloxacin Otic 0.3%

Apotex Corp. today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for ofloxacin otic, 0.3%. Apotex confirmed it was first-to-file and that it will receive 180-days of market exclusivity. Shipments of the drug are expected to commence pending the successful outcome of ongoing litigation.

The patent owner, Daiichi, initiated suit against Apotex in March 2003 in the United States District Court for the District of New Jersey. The bench trial in that case ended on November 17, 2005. On November 28, 2005, the district court entered an order preventing Apotex from marketing its approved generic Ofloxacin Otic Solution pending the court’s decision on the merits of Daiichi’s infringement claim. The order also prevents Daiichi from launching an authorized generic version of its Floxin(R) product until final judgment is entered in the case. Apotex continues to believe in the merits of its defenses.

Ofloxacin otic is the generic equivalent of Daiichi’s Floxin(R). Annual sales for the brand are approximately $90 million.

The Apotex Group manufactures more than 60 different high-quality generic pharmaceuticals, used by millions of patients worldwide. Its product line includes oral solids, liquids, injectables, nasal sprays, ophthalmics and inhalation solutions.

Floxin(R) is a registered trademark of Daiichi.

Apotex Corp. is the U.S. subsidiary of Apotex Inc., the largest Canadian-owned manufacturer of prescription drugs. Through its sales and marketing headquarters in Weston, Florida and operations center in Indianapolis, Apotex Corp. is committed to providing safe and affordable generic medicines. Products manufactured and marketed by the Apotex Group are sold in 115 countries around the world. For more information visit apotexcorp.com.