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Generic Floxin Otic Solution Granted Tentative Approval
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 U.S. 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.
Source: Hi-Tech Pharmacal