Perrigo announced that it has acquired the exclusive US 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. Teva Pharmaceutical Industries Ltd. currently has Rx approval for these products, and Teva and sanofi-aventis have settled their Paragraph IV/Hatch-Waxman litigation.
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 FDA for the Rx-to-OTC switch of these drugs. 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.
Perrigo's chairman and CEO Joseph C Papa stated, "This is another example of Perrigo's strategic focus on making quality healthcare more affordable to American consumers by introducing new Rx-to-OTC switch products."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, active pharmaceutical ingredients (API) and consumer products.