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No exclusivity for Ranbaxy’s FDA approved drugs

Mar 22, 2000

The US Food and Drug Administration (FDA) has given Ranbaxy’s wholly owned US subsidiary, Ranbaxy Pharmaceuticals Inc. permission to market pentazocine plus naloxone tablets in the USA. These are used for relieving acute pain post–operative surgeries. Ranbaxy is among the top Indian pharmaceutical companies ranks second in terms of domestic sales. It has interests in anti–infectives, respiratory and cardiovascular. It possesses 12 brands among the top 250 brands in the country and in terms of its therapeutic dosage offerings covers around 77% of the market.

With almost $32 bn worth of drugs going off patent (more than 5 times the Indian market) over the next four year’s in the USA, top Indian pharma companies are focusing on the US generic market to drive topline growth. Bottomline performance however, is critically dependent on the time to the market. This is so since within the first two years prices of generic drugs drop almost 80%. Hence it is the first two entrants which make money on the introduction of a new drug in the generic market.

An approval for the generic product has already been granted to a US based company and hence Ranbaxy would not enjoy the 180–day period of exclusivity that the first company getting generic approval is entitled to. So, how lucrative the introduction of these drugs will prove for Ranbaxy remains to be seen.

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