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Generic Version of Ditropan Granted Final Approval
Robert J. Coury, Mylan's Vice Chairman and Chief Executive Officer commented: "This is the latest milestone achievement in Mylan's long history of successfully developing difficult to formulate and difficult to manufacture generic products. Mylan has once again differentiated itself in the industry through the successful development of this product, and based on the limited number of competitors that have filed oxybutynin applications, we expect that it will be a valuable component of our product portfolio for the 180 days of market exclusivity and beyond."
Mylan is the first generic drug company to file ANDAs with the FDA for 5 mg and 10 mg Ditropan XL, and as such, the company has 180 days of market exclusivity for those strengths. Mylan has entered into two agreements with Ortho-McNeil Pharmaceuticals and Alza that ensures Mylan's ability to launch the 15 mg strength at market formation.
Source: Mylan Laboratories