Orchid, Lupin get FDA OK on Cefprozil, generic of Bristol-Meyers Squibb's antibiotic Cefzil

By E. Janene Geiss

Philadelphia, Dec. 20 - Orchid Chemicals & Pharmaceuticals Ltd. and Lupin Ltd. both announced that they received approval from the Food and Drug Administration for the Abbreviated New Drug Applications for Cefprozil tablets and Cefprozil oral suspension.

Cefprozil is the generic equivalent of Bristol-Myers Squibb's Cefzil for the treatment of bacterial infections such as ear, throat and skin infections and bronchitis.

Orchid said it has received the formal approval for Cefprozil tablets at 250 mg and 500 mg doses. The current U.S. market size for Cefprozil tablets is $117 million, Orchid officials said.

The company said it will launch the product exclusively through Par Pharmaceuticals immediately upon the expiry of the patent on Wednesday.

This is the eighth cephalosporin ANDA approval the company has received covering four cephalosporin products in various dosage forms. The company said it expects more ANDA approvals to follow in the months to come. It has filed 21 ANDAs with the FDA, officials said.

"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," said K Raghavendra Rao, Orchid's managing director, in its company news release.

In a separate announcement, Lupin said it received approval for its ANDA for Cefprozil oral suspension at 125 mg/5 ml and 250 mg/5 ml.

The suspension market in the United States is estimated at $119 million as per IMS MAT June 2005 data, the company said.

Earlier this month, Lupin said it received approval for Cefprozil tablets. The latest approval is the company's 10th ANDA approval by the FDA this year.

"The timely approval of this ANDA now enables us to offer both the tablets and the powder for suspension which is essential for the product's success. Together the Cefzil brand clocks in at $236 million and we look forward to capturing a profitable market share post patent expiry on Dec. 23, 2005," said Lupin chairman D.B. Gupta in that company's news release.

Orchid is a Chennai, India, pharmaceutical company with a focus on bulk drugs, formulations and drug discovery.

Lupin is a Mumbai, India, drug manufacturer that makes active ingredients and finished products to treat tuberculosis, bacterial infections and cardiovascular diseases.

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