Hi-Tech Pharmacal's Abbreviated New Drug Application (ANDA) for Ofloxacin otic solution, 0.3% has been granted tentative approval by US Food and Drug Administration (FDA). Hi-Tech's Ofloxacin otic solution is the generic equivalent of Daiichi's Floxin otic solution, 0.3% indicated for the treatment of bacterial infections of the ear which in 2004, had sales of $77 million.

Floxin is covered by a US patent listed in the Orange Book and currently subject to a litigation between Daiichi and Bausch & Lomb, which was first to file an ANDA on this product. If the US patent listed in the Orange Book is held invalid or unenforceable, Bausch & Lomb will be granted marketing exclusivity for 180 days. Hi-Tech expects to start marketing its generic version of Floxin upon expiration of this marketing exclusivity period, or upon expiration of the patent in 2012, according to a company release.