Elite, SunGen get FDA nod for generic Adderall XR

Sandra Levy
Senior Editor
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Elite has received the Food and Drug Administration’s green light for a generic version of Shire’s Adderall XR. The product is an extended-release mixed salt of a single-entity amphetamine product (dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate).

It comes in tablets in dosage strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg.

The product is a central nervous system stimulant that is indicated for the treatment of attention deficit hyperactivity disorder

The branded product and its equivalents had a market value of $1.3 billion for the 12 months ended October 2019, according to IQVIA.

Generic Adderall XR is jointly owned and the second product approval for Elite and SunGen’s collaboration. Elite will manufacture and package the product on a cost-plus basis. Lannett will be the exclusive U.S. distributor.

"We are pleased to have received approval of this second product co-developed with our partner, SunGen. Launch of this product is our top priority," said Nasrat Hakim, Elite president and CEO.

"We are very pleased to have another ANDA approval through our partnership with Elite and achieve a significant milestone for SunGen as we work on the launch of the recently approved generic Adderall XR," said SunGen co-CEO Jim Huang.

Lannett CEO Tim Crew said, "Our strategic alliance partners already have received FDA approval for generic Adderall XR, paving the way for a near-term launch," said "Generic Adderall XR complements our previously launched generic Adderall immediate release and is included in the dozen or so products we expect to launch by the end of our current fiscal year. While the Adderall XR market is sizable, there currently are several generic suppliers for this product."