Lupin Pharmaceuticals Inc. (LPI), a US subsidiary of Pharma major Lupin Limited has received tentative approval for its armodafinil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths as well as another tentative approval for its doxycycline capsules, 40 mg (30 mg immediate release and 10 mg delayed release) from the US FDA.
Lupin's armodafinil tablets are AB-rated generic equivalent of Cephalon Inc.'s nuvigil tablets 50 mg, 100 mg, 150 mg, 200 mg and 250 mg strengths. Armodafinil tablet is indicated to improve wakefulness in adult patients with excessive sleepiness associated with treated obstructive sleep apnea (OSA), nacrolepsy or shift work disorder.
Nuvigil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg had US sales of approximately US$ 420 million, for the 12 months ending March 2013 (IMS Health data).
Lupin's doxycycline capsules is the AB-rated generic equivalent of Galderma Laboratories' oracea capsules, 40 mg. Doxycycline capsule is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients.
Oracea capsules had annual US sales of approximately US$ 319 million for 12 months ending march 2013 (IMS Health data).