After More Than A Decade: Chinese regulator gives nod for Dr Reddy's cardiac drug

Hyderabad: After a 11-year long wait, Dr Reddy's Laboratories (Dr Reddy's) has finally bagged the approval from the Chinese regulator for its anti-blood clotting drug Clopidogrel.

The Chinese regulator has shown a green flag to the drug, which is expected to land up in sales worth over Rs 11,175 crore ($1.6 billion).

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.

According to a clarification given to stock exchanges, the city-based drug maker said sales of this drug would not be materialised in the current financial year.

"Please note that the Company has received approval for the product Clopidogrel in China.The Company believes that the sales from this product will not be material in the current financial year i.e. FY2020," Dr Reddy's said.

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 $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 said.