After a patent lawsuit is settled, Teva will have 180 days exclusivity to market the generic version of Ortho McNeil's Levaquin.
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced today that the US Food and Drug Administration has granted final approval for the company's ANDA for Levofloxacin tablets, 750 mg.
Teva's Levofloxacin Tablets are the AB-rated generic equivalent of Ortho McNeil Pharmaceutical Inc.'s broad spectrum antibiotic Levaquin tablets.
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, 750 mg. Shipment of this product will not commence at least until a decision in a pending patent litigation in the U.S. District Court for the District of New Jersey.
Teva stated that it expects to receive final approval for its Levofloxacin tablets in the 250 mg and 500 mg strengths upon the earlier of the expiration of another ANDA filer's 180-day marketing exclusivity, which has not started, or the expiration of the patent.
Published by Globes [online], Israel business news - www.globes.co.il - on Thursday, January 27, 2005