After 11 years, Dr Reddys Lab gets Chinese regulator nod for generic Clopidogrel

Hyderabad: After a decade long wait, Dr Reddy's Laboratories (Dr Reddys) has finally bagged the approval from the Chinese regulator for its anti-blood clotting drug Clopidogrel. According to a recent media report, the Chinese regulator has shown a green flag to the drug, which is expected to land up in sales worth over Rs 11175 crore (USD 1.6 billion).

As per a recent report in Business Standard, DRL received approval for generic Clopidogrel earlier this month. The drug is indicative of preventing blood clotting primarily and acts against cardiovascular issues. Clopidogrel, sold under the trade name Plavix among others, is an antiplatelet medication used to reduce the risk of heart disease and stroke in those at high risk.

Presently, the drug is undergoing generic equivalent assessment (China requires drugmakers to conduct bioequivalence studies).

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Prior to this in 2012, DRL had launched generic Clopidogrel in the United States market along with its partner Mylan. The move came in following the expiry of patent for Sanofi-Aventis' Plavix, one of the best selling drugs in the US. During the patent period, the drug approximately had an annual sale of around USD 6.7 billion.

According to Edelweiss analyst, DRL has seven to eight products lined up for approval from the Chinese drug regulator and it expects to increase the number of filings.

“DRL is the largest international generic pharmaceutical company in China with presence across all provinces. In FY18, DRL clocked around $100 million sales from 8-10 products with sales accounted for in its joint venture (JV), Kunshan Rotam Reddy (DRL owns 51.3 per cent interest),” Edelweiss told Business Standard. The Joint Venture has a sales and marketing team covering 5000 hospitals spread over China.

It is learnt through the media report that the launch of the formulation will take a while and the move would be DRL's biggest product in China concerning market potential.

As per analysts, it takes around seven to eight years in China to receive approvals. However, as part of some friendly market reforms which will expedite the generic approval timelines, the Government is looking at speeding up the procedure. Thus, approvals for companies from outside China has increased in recent time.

After the US, China is reportedly the world’s second-largest single country pharma market and according to estimates around 25 per cent of the drugs by value to Chinese hospitals are supplied by companies outside of the country.