Momenta Pharmaceuticals - CEO Craig Wheeler on Q4 2014 Results - Earnings Call Transcript
Copaxone discussion excerpts -
Our generic Copaxone ANDA is still under FDA review. As I said in our last earnings call we have no outstanding questions from the FDA and we believe we have supplied the FDA with everything they need to approve the Sandoz Momenta application.
I still believe our application could be approved at anytime. We remain in contact with the agency and have been given no indication that there are any outstanding review issues.
As a reminder Teva's manufacturing patent that expires in September is not listed in the Orange Book and therefore the FDA may grant final approval to any ANDA for a generic 20 milligram Copaxone at any time.
Once approved we continue to believe that there remains a significant commercial opportunity for our generic Copaxone. Teva reports it has switched approximately 63% of Copaxone patients to the three times per week formulation. Even with this share shift we continue to see high anticipation for a generic product in the MS market.
Market Data 
Markets 
AI
