By -
Jun 27, 2014
Ranbaxy Laboratories Ltd. (RBXY) surged to
an 18-month high in Mumbai trading after winning U.S. approval
to make Novartis AG (NOVN)’s blood pressure drug Diovan almost two
years after the $3.5 billion medicine lost patent protection.
Ranbaxy gained as much as 8 percent to 510.75 rupees, headed for the highest level since January 2013 before trading at 495.05 rupees at 9:35 a.m. in Mumbai today. Sun Pharmaceutical Industries Ltd. (SUNP), which agreed in April to purchase Ranbaxy, gained as much as 6.3 percent.
Ranbaxy has held exclusive rights to copy Diovan for the first six months of the medicine’s generic period though it couldn’t manufacture the drug after plants in India failed inspections. The Food and Drug Administration approved Ranbaxy’s Ohm Laboratories in New Jersey to make the generic, Christopher Kelly, a spokesman for the agency, said in an e-mail.
Ranbaxy had planned to produce generic Diovan at its plant in Mohali, Punjab. The FDA banned the facility from selling products in the U.S. in September 2013. Three more Ranbaxy plants in India are prohibited from U.S. sales dating back to 2009. The Gurgaon, India-based company has been cited for unsanitary conditions and manipulating quality tests.
Once Ranbaxy’s generic Diovan has been on the market for six months, other drugmakers are eligible to gain FDA approval and introduce their versions to the market. Diovan lost patent protection in September 2012.
Diovan and a version of the drug combined with a diuretic that is already generic generated $3.5 billion in revenue last year, making the combined therapies the second-best selling medicine for Basel, Switzerland-based Novartis.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Anjali Cordeiro, Frank Longid
Ranbaxy gained as much as 8 percent to 510.75 rupees, headed for the highest level since January 2013 before trading at 495.05 rupees at 9:35 a.m. in Mumbai today. Sun Pharmaceutical Industries Ltd. (SUNP), which agreed in April to purchase Ranbaxy, gained as much as 6.3 percent.
Ranbaxy has held exclusive rights to copy Diovan for the first six months of the medicine’s generic period though it couldn’t manufacture the drug after plants in India failed inspections. The Food and Drug Administration approved Ranbaxy’s Ohm Laboratories in New Jersey to make the generic, Christopher Kelly, a spokesman for the agency, said in an e-mail.
Ranbaxy had planned to produce generic Diovan at its plant in Mohali, Punjab. The FDA banned the facility from selling products in the U.S. in September 2013. Three more Ranbaxy plants in India are prohibited from U.S. sales dating back to 2009. The Gurgaon, India-based company has been cited for unsanitary conditions and manipulating quality tests.
Once Ranbaxy’s generic Diovan has been on the market for six months, other drugmakers are eligible to gain FDA approval and introduce their versions to the market. Diovan lost patent protection in September 2012.
Diovan and a version of the drug combined with a diuretic that is already generic generated $3.5 billion in revenue last year, making the combined therapies the second-best selling medicine for Basel, Switzerland-based Novartis.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Reg Gale at rgale5@bloomberg.net Anjali Cordeiro, Frank Longid
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