On 29 June 2010, Perrigo announced that it had acquired the exclusive US rights to sell and distribute OTC versions of Fexofenadine HCl 180 mg and 60 mg tablets, plus Fexofenadine HCl 60 mg and Pseudoephedrine 120 mg tablets, the generic versions of sanofi-aventis’ Allegra and Allegra D-12 products. Teva Pharmaceutical Industries currently has prescription (Rx) approval for these products, and Teva and sanofi-aventis have settled their Paragraph IV litigation.
Rights to Allegra acquired by generics’ manufacturer Perrigo
Home/Pharma News | Posted 10/08/2010 0 Post your comment
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 US$1.5 billion, and in 2009, Allegra D-12 had annual sales of US$600 million.
Perrigo’s Chairman and CEO, Mr 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”.
US-based Perrigo develops, manufactures and distributes OTC and generic prescription pharmaceuticals, nutritional products, infant formula, active pharmaceutical ingredients and consumer products. The company is the world’s largest manufacturer of OTC pharmaceutical products for the store brand market.
Reference:
Perrigo Company Press Release, Perrigo acquires exclusive sales and distribution rights to OTC store brand versions of Allegra and Allegra D-12 from Teva. 29 June 2010
Guidelines
Regulatory update for post-registration of biological products in Brazil
New regulations in Brazil for the registration of biosimilars
Policies & Legislation
NPRA Malaysia trials new timelines for variation applications
Regulatory evolution and impact of simplified requirements for interchangeable biosimilars in the US
Most viewed articles
The best selling biotechnology drugs of 2008: the next biosimilars targets
Global biosimilars guideline development – EGA’s perspective
Related content
Meitheal expands portfolio with three biosimilars through exclusive US licensing agreement
EMS proposes merger with Hypera to form Brazil's largest drugmaker
Bio-Thera and Gedeon Richter partner to commercialize Stelara biosimilar BAT2206
Advances for Biocon Biologics’ Stelara and Eylea biosimilars
Comments (0)
Post your comment