The abbreviated new drug application (ANDA) is for Levofloxacin tablets 750mg, the AB-rated generic equivalent of Ortho McNeil Pharmaceutical broad spectrum antibiotic.
As the first ANDA applicant to file an ANDA with a paragraph IV patent certification, Teva has been awarded 180 days of generic drug exclusivity for Levofloxacin tablets 750mg.
Shipment of this product will not commence at least until a decision in the pending patent litigation in the US District Court for the District of New Jersey is made.
In addition, Teva expects to receive final approval for its Levofloxacin tablets in the 250mg and 500mg strengths upon the earlier of either the expiration of another ANDA filer’s 180-day marketing exclusivity, or the expiration of the patent.