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In some cases, patent regulation additionally collides with the FDA's manufacturing guidelines. For example, the Novartis patent for Diovan expired in 2012. Ranbaxy obtained exclusivity for a hundred and eighty days for the first generic product. However, due to poor high quality manufacturing, Ranbaxy couldn't receive ultimate FDA approval for its generic version. The FDA banned shipments of Ranbaxy products to the United States. Ranbaxy ended up paying a $500 million fine , the most important penalty paid by a generic agency for violations.
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