ALLEGAN, Mich. Perrigo on Tuesday announced that it has acquired the exclusive U.S. store brand rights to sell and distribute OTC versions of fexofenadine HCl 180 mg and 60 mg tabs, plus fexofenadine HCl 60 mg and pseudoephedrine 120 mg tabs, the generic versions of Sanofi-Aventis' Allegra and Allegra D-12 products, respectively.
Allegra 180 mg, 60 mg, and Allegra D-12 are indicated for the relief of symptoms associated with seasonal allergies. Sanofi-Aventis has applied to the Food and Drug Administration for the Rx-to-OTC switch of these drugs, even going so far as to acquire OTC supplier Chattem as an in-house distribution arm for the allergy medicine.
It is assumed Allegra will be approved for its switch OTC, especially as an FDA advisory committee in 2001 recommended Allegra be eligible for switch.
Prior to generic competition entering the fexofenadine Rx market in 2005, Allegra 180 mg and 60 mg had combined annual sales of approximately $1.5 billion, and in 2009, Allegra D-12 had annual sales of $600 million according to data provided by Wolters-Kluwer.