Ranbaxy Laboratories has got the US drug regulator's nod to sell its low-cost version of the world's best selling drug Lipitor in the US just in the nick of time after it clinched the regulator's nod hours before the cholesterol lowering drug's patent expires.
"Ranbaxy Laboratories has gained approval to make generic atorvastatin calcium tablets (chemical name of Lipitor) in 10 milligram, 20 mg, 40 mg, and 80 mg strengths, US Food and Drug Administration (FDA) said in a statement. The drug will be manufactured by Ohm Laboratories in New Brunswick, New Jersey, it said."
The approval marks an end to the months of uncertainty and the secrecy surrounding the approval of the drug which could earn Ranbaxy over $500 million during an exclusive 6-month period in the US.
"Ranbaxy Laboratories has gained approval to make generic atorvastatin calcium tablets (chemical name of Lipitor) in 10 milligram, 20 mg, 40 mg, and 80 mg strengths, US Food and Drug Administration (FDA) said in a statement. The drug will be manufactured by Ohm Laboratories in New Brunswick, New Jersey, it said."
The approval marks an end to the months of uncertainty and the secrecy surrounding the approval of the drug which could earn Ranbaxy over $500 million during an exclusive 6-month period in the US.
An agreement between Pfizer Inc and Ranbaxy in June 2008 allows the Indian drugmaker to launch its atorvastatin drug, on November 30. During the first 180-days, it will be the only generic drugmaker, besides Pfizer Inc and its generic partner Watson Pharmaceuticals and could fetch the country's largest drugmaker between $500-600 million.
Shares of Daiichi Sankyo Co., Ranbaxy’s Tokyo-based majority owner, gained the most in 12 weeks in Tokyo trading after the announcement, which was made on Nov. 30 in Washington.
Daiichi Sankyo advanced 3.1 percent to 1,416 yen on the Tokyo Stock Exchange at 10:50 a.m. local time. The benchmark Topix index climbed 1.8 percent.
Mylan Inc. of Canonsburg, Pennsylvania; Teva Pharmaceutical Industries Ltd. of Petach Tikvah, Israel and Dr. Reddy’s Laboratories Ltd. of Hyderabad, India, are among generic-drug makers seeking FDA approval to sell Lipitor copies after Ranbaxy’s six-month exclusivity expires, according to U.S. court filings.
"A portion of the profits from sales of atorvastatin [generic version of Lipitor] during Ranbaxy's 180-day first-to-file exclusivity period will be paid to Teva,"
Indian shares rise 3.7 pct; Ranbaxy up over 10 pct
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