Perrigo Squares Off With Dr. Reddy’s In Lansoprazole Launch
This article was originally published in PharmAsia News
U.S. FDA denied Perrigo’s petition that had sought to block Dr. Reddy’s ANDA for generic Prevacid 24HR because it used bioequivalence data for the proton pump inhibitor’s Rx version. Competition between the firms is intensifying as Dr. Reddy’s expands its U.S. OTC presence.
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The private labeler lowered its full-year revenue guidance, noting weak cough/cold/flu OTC sales. Perrigo built up excess capacity to take advantage of recalled Johnson & Johnson OTCs, and now is shifting some capacity in response to a Novartis plant shutdown.
The Indian private labeler predicts annualized U.S. OTC sales of $200 million by March 2013. Dr. Reddy’s recently launched an equivalent of Allegra-D 24 Hour and plans to introduce generic Prevacid 24HR in its next fiscal year.