Orchid Chemicals and Pharmaceuticals Ltd has received the formal approval from the US FDA for its abbreviated new drug application (ANDA) for cefprozil tablets USP, 250 mg and 500 mg. The current US market size for cefprozil tablets is USD 117 million.
According to the company release, Orchid Chemicals will launch the product exclusively through Par Pharmaceuticals immediately upon the expiry of the patent on December 23, 2005.
This is the eighth cephalosporin ANDA approval that the company has received till date covering four cephalosporin products in various dosage forms. The company expects more ANDA approvals to follow in the months to come. As of date, the company has filed 21 ANDAs with the US FDA.
"This is an important approval in our regulated markets strategy. We are happy that we have received the approval in time to launch the product immediately after the patent expiry (December 23, 2005). We expect cefprozil to be a lead product in the distribution alliance with Par Pharmaceuticals in the US generics market and are confident of capturing a sizeable share of the oral cephalosporin generic formulations market going forward," said K Raghavendra Rao, managing director, Orchid Chemicals.