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US court rejects Mylan’s plea against Ranbaxy
The US court has dismissed Mylan’s petition challenging Ranbaxy’s exclusive marketing
rights over the generic version of Pfizer’s Lipitor. Mylan had sued the USFDA for providing
the exclusive right to Ranbaxy, alleging that the permission was given on the basis of
’falsified data’. In response to Mylan’s plea, the FDA said the company’s complaint was
premature and the agency's enforcement discretion was not reviewable by a court. It also
indicated that drug makers cannot sue over pending applications filed by their competitors.
Ranbaxy is expected to launch its generic Lipitor on November 30 under a settlement deal
with Pfizer having a 180 day-exclusivity (FTF opportunity). Ranbaxy is awaiting a final
approval from the USFDA for the same. Lipitor’s global sales were US$10.7bn in 2010,
with US sales of US$5.33bn. The ruling is a positive development coming in as a relief
for Ranbaxy. We maintain our estimates and recommend Buy on the stock with a target
price of `588.
India Equity Research Reports, IPO and Stock News
Visit http://indiaer.blogspot.com/ for complete details �� ��
US court rejects Mylan’s plea against Ranbaxy
The US court has dismissed Mylan’s petition challenging Ranbaxy’s exclusive marketing
rights over the generic version of Pfizer’s Lipitor. Mylan had sued the USFDA for providing
the exclusive right to Ranbaxy, alleging that the permission was given on the basis of
’falsified data’. In response to Mylan’s plea, the FDA said the company’s complaint was
premature and the agency's enforcement discretion was not reviewable by a court. It also
indicated that drug makers cannot sue over pending applications filed by their competitors.
Ranbaxy is expected to launch its generic Lipitor on November 30 under a settlement deal
with Pfizer having a 180 day-exclusivity (FTF opportunity). Ranbaxy is awaiting a final
approval from the USFDA for the same. Lipitor’s global sales were US$10.7bn in 2010,
with US sales of US$5.33bn. The ruling is a positive development coming in as a relief
for Ranbaxy. We maintain our estimates and recommend Buy on the stock with a target
price of `588.
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