Natco Pharma, a Rs 400 crore Hyderabad-based pharma company, is planning to suitably respond to Teva Pharma's Citizen Petition with the US FDA regarding Glatiramer Acetate product. Teva had alleged, that there is a significant difference between Natco's product and its Copaxone. According to Natco Pharma the petition is intended to prolong Teva's monopoly on Copaxone, used in the treatment of multiple sclerosis. This Citizen Petition is very similar to another petition which Teva had filed in 2008, which was rejected by US FDA earlier this year.
Natco and Mylan's abbreviated new drug application for Glatiramer Acetate has been accepted for review by the US FDA in September 2009 and the review is presently on going. This attempt of Teva is to delay the approval of the ANDA. This product is extremely important for Teva's sales (US$ 11.1 billion in 2008) and it is the largest product in their portfolio. For Natco, this product, on approval, represents a significant upside. Natco is the only generic producer in world of this product, involving complex peptide chemistry.
Natco press release said that the company stands firmly behind the safety and integrity of its marketed Glatiramer Acetate product and it will respond to Teva's unfounded claims.