Why generic companies might like 505(b)(2)

How would you like to spend a couple of hundred thousands of dollars (or equivalent local currency) and countless months getting FDA approval and patent expiration and then face 14 competitors?  What’s the ROI for that?

June 1, 2011

• Donepezil Hydrochloride Tablets, Matrix Laboratories Ltd., Approval
• Donepezil Hydrochloride Tablets, Cipla Ltd., Approval
• Donepezil Hydrochloride Tablets, Wockhardt Ltd., Approval
• Donepezil Hydrochloride Tablets, Roxane Laboratories, Inc., Approval
• Donepezil Hydrochloride Tablets, Sandoz Inc., Approval
• Donepezil Hydrochloride Tablets, Sun Pharmaceutical Industries Ltd., Approval
• Donepezil Hydrochloride Tablets, Huahai US Inc., Approval
• Donepezil Hydrochloride Tablets, Hikma Pharmaceuticals, Approval
• Donepezil Hydrochloride Tablets, Actavis Pharma, Approval
• Donepezil Hydrochloride Tablets, Torrent Pharmaceuticals Ltd., Approval
• Donepezil Hydrochloride Tablets, Pliva Hrvatska, Approval
• Donepezil Hydrochloride Tablets, Jubilant Life Sciences Ltd., Approval
• Donepezil Hydrochloride Tablets, Teva Pharmaceuticals, Approval
• Donepezil Hydrochloride Tablets, Dr. Reddy’s Laboratories Ltd., Approval
• Donepezil Hydrochloride Tablets, Aurobindo Pharma, Approval