Lupin receives US FDA approval for generic diabetic drug

Lupin Pharmaceuticals Inc, the US subsidiary of Indian pharma major Lupin Ltd (Lupin), has received final approval from the United States Food and Drugs Administration (FDA) to market a generic version of CP Pharmaceuticals' `Lyrica' capsules.

Lyrica (Pregabalin) capsules are indicated for neuropathic pain associated with diabetic peripheral neuropathy, post herpetic neuralgia, adjunctive therapy for adult patients with partial onset seizures and fibromyalgia, the company said in a release today.

Lupin has received permission to market its Pregabalin capsules - 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg, which, the company said, are AB-rated generic equivalent of Lyrica capsules.

Lyrica capsules had annual US sales of approximately $1.8 billion in the 12 months ended March 2012, as per IMS Health Sales Data, the release noted.

Lupin is the 5th largest and fastest growing generics player in the US, with a 5.3-per cent market share by prescriptions, the only Asian company to achieve that distinction. The company is also the fastest growing top 10 pharmaceutical player in India, Japan and South Africa.

For the financial year ended March 2012, Lupin reported after-tax profit of Rs867.6 crore ($190 million) on consolidated revenues of Rs7,082.9 crore ($1.42 billion).

Based in Mumbai, Lupin has a significant presence in the cardiovascular, diabetology, asthma, paediatrics, CNS, GI, anti-infective and NSAID space in addition to holding global leadership positions in the anti-TB and cephalosporin segments.