Watson Labs Rosuvastatin Zinc 505(b)(2)


On Oct 27, 2010, Watson confirmed the patent challenge on Rosuvastatin (Astrazeneca sued watson at Delaware). Watson has submitted new drug application under Section 505(b)(2) seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets (press release).

On Nov 10, 2010, Watson is again sued by Astrazeneca in District court of Nevada (View on PriorSmart).

For Creastor, four patents are listed in FDA orange book, which are Product (RE37314), Composition (6316460), and secondary Method of treating claim patents (7030152, 6858618).

Watson has certified that its NDA does not infringe ‘314 patent. FDA’s approval of this NDA is stayed until March 30, 2013 or until final resolution of this matter.

EGIS has rosuvastatin zinc patent application filed (WO2007119085; priority of April 2006) and has approved DMF.

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About Guna

Interested to learn things around me
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