Lupin gets USFDA approval for generic Cymbalta capsules & eyes $300 mn revenue from Japan in next 2 yrs

12 Dec 2011 Evaluate

Drug maker Lupin has received approval fromthe US health regulator to market Duloxetine Hydrochloride capsules, used to treatmajor depressive disorder, in the American market. The company has receivedtentative approval from the US Food and Drug Administration (USFDA) for itsDuloxetine Hydrochloride Delayed-release (HCl DR) capsules in strengths of 20mg, 30 mg and 60 mg. TheMumbai-headquartered firm's capsules are the generic equivalent of Eli Lily'sCymbalta Delayed-release capsules. According to IMS Health data,Cymbalta HCl DR capsules had annual US sales of nearly $3.5 billion for 12months to September. Duloxetine HCl DR capsules are indicated for the treatmentof various ailments including major depressive disorder and generalised anxietydisorder (GAD).In another development, Lupin is eyeing a jumpof over 80% in its revenues to $300 million (Rs 1,557 crore) from the Japanesemarket in the next two years on the back of its enhanced presence in thecountry. The company, which is present in Japan through its subsidiary KyowaPharmaceutical Industry, has strengthened its presence with the acquisition ofI'rom Pharmaceuticals for an undisclosed amount Besides US and India, Japan is a priority market forLupin. The company, through its enhanced presence is aiming tobecome one of the top five generic pharmaceutical companies in Japan in thenext three years. Currently, Lupin is the ninth largest generic player in theJapanese Market. Apart from Japan, the company is also eyeing to enter othermarkets, including Latin America and Europe.

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