East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Armodafinil Tablets, 50 mg, 150 mg, and 250 mg. Aurobindo’s Armodafinil tablets are an AB-rated generic equivalent to the reference listed drug NUVIGIL®.

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), narcolepsy or shift work disorder (SWD).

The product has an estimated market size of $104M for the twelve months ending January 2018 according to IMS*.

Armodafinil tablets represent the latest addition to Aurobindo’s broad line of vertically integrated generic pharmaceuticals. Aurobindo’s product portfolio consists of 292 final approvals, including 38 tentative approvals, and 17 approved products from Aurolife. There are 106 additional products on file with U.S. FDA.

* IMS National Sales Perspectives: Retail and Non-Retail MAT January 2018