Breckenridge Pharmaceutical has acquired five Abbreviated New Drug Applications (ANDAs) from Nostrum Laboratories. Three of the acquired assets are FDA approved and will be sold by Breckenridge under its label. Two of the assets are filed and pending with FDA with anticipated approval dates within the next 12 months. The total generic market value for these products is $305 Million, according to July 2017 IMS data.
The three approved ANDAs are CNS products indicted for the treatment of Attention Deficit Disorders and Narcolepsy Attention Deficit Disorders in various dosage forms.
The parties have entered into a separate agreement whereby Nostrum will remain the exclusive manufacturer for certain assets.