Lupin’s arm receives Tentative FDA Approvals for Generic Nuvigil Tablets and Generic Oracea Capsules

31 Jul 2013 Evaluate

Pharma Major Lupin’s  U.S. subsidiary- Lupin Pharmaceuticals, Inc. (LPI) 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 United States Food and Drugs Administration (FDA).

Lupin's Armodafinil Tablets are the 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), narcolepsy, or shift work disorder.

Nuvigil tablets, 50 mg, 100 mg, 150 mg, 200 mg and 250 mg had U.S sales of approximately$ 420 million, for the twelve 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 U.S sales of approximately $ 319 million for the twelve months ending March, 2013 (IMS Health data).

Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).

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