Barr Laboratories Inc has received approval from the U.S. Food & Drug Administration for generic Adderall (Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate) Tablets, 7.5 mg, 12.5 mg, 15 mg. This mixed salts of a single-entity amphetamine product is an AB rated generic equivalent of Shire US Inc's Adderall tablets. The Company will launch these three product strengths immediately.
The Company said that it has been granted 180 days of generic exclusivity, commencing at launch, as a result of being the first to file an Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for the listed patent. The patent holder did not file suit against Barr within the statutory forty-five day period.
In February 2002, Barr was the first to market and launch a generic equivalent to Shire's Adderall Tablets, 5 mg, 10 mg, 20 mg and 30 mg.
"Our ability to gain the first generic approval and 180 day market exclusivity for the additional strengths of generic Adderall expands our current portfolio of dextroamphetaphine products, which includes generic versions of GlaxoSmithKline's Dexedrine Spansules and Shire's Dextrostat, as well as a filing for Shire's Adderall XR product, and demonstrates our ability to accelerate the development of barrier-to-entry products to ensure that we reach the marketplace before competitors," said Bruce L. Downey, Barr's Chairman and CEO.
Adderall is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional ability and impulsivity.
Adderall Tablets, 7.5 mg, 12.5 mg, and 15 mg have annual sales of approximately $18 million for the twelve months ending January 2003.