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Four Indian drug makers get US nod to launch generic version of Plavix

BS Reporter  |  New Delhi 

Four Indian drug makers — Dr Reddy’s Laboratories Ltd, Ltd, Ltd and Ltd — have received approval from the US Food and Drug Administration (USFDA) to launch a low-cost version of blood-thinning drug in the US. The drug is used to reduce the risk of and stroke.

Dr Reddy’s has also secured a 180-day marketing right for its generic version in 300 mg. However, the Hyderabad-based company may have to share its right with two other foreign companies, Ltd and Inc, which were also among the first to file for a right to launch the generic version of the drug.

The approval assumes significance, given the huge market size of the drug. is the world’s second-largest selling drug brand. Marketed by Sanofi-Aventis in 75 mg and 300 mg tablets, garnered sales worth $6.7 billion (around Rs 36,850 crore) in the US in the year ended March 31, 2012.

  • Plavix, a blood-thinning drug, is used to reduce and stroke risk
  • The total US market for generic is $6.7 billion per year
  • Dr Reddy’s Laboratories is the only Indian company with a 180-day marketing exclusivity for 300 mg generic
  • Pharmaceuticals Inc and Teva to share marketing exclusivity with Dr Reddy’s Lab
  • Sun Pharma, Torrent Pharma and to sell the drug in 75 mg; Dr Reddy's to sell in 75 mg, too

(Source: Companies, industry data)

Analysts say even with a shared exclusivity, Dr Reddy’s is set to gain from the drug’s launch because of the significant size of the market. “Dr Reddy’s has launched the drug in both the strengths (75 mg and 300 mg) and will also enjoy exclusive marketing (right) for the 300 mg tablets. It’s a huge opportunity for the company,” an analyst said.

Shares in Dr Reddy’s on Friday ended at Rs 1,664.50 on the National Stock Exchange, marginally up by 0.1 per cent from their close on Thursday.

According to market analysts, the impact of the development on the stock is yet to come. “The launch was announced just on Friday, but the broad market was down through the day. I am hoping to see at least two-three per cent jump in shares of Dr Reddy’s on Monday,” a market analyst said.

While Dr Reddy's has received the approval for the generic drug in both 300 mg and 75 mg tablets, other Indian drug makers such as Aurobindo Pharma, Sun Pharma and Torrent Pharma have received the nod for the 75 mg tablets.

Besides, foreign such as Teva Pharma, Mylan, Apotex Inc and Roxane Laboratories Inc have also received the USFDA’s nod for selling the low-cost version of in strength of 75 mg in the US.

“For people who must manage chronic health conditions, having effective and affordable treatment options is important,” said Keith Webber, deputy director, Office of Pharmaceutical Science at USFDA’s Center for Drug Evaluation and Research. “The generic products approved on Friday will expand those options for patients.”

According to a statement from USFDA, the drug would also contain a boxed warning to alert that it may not work well for those with certain genetic factors that affect how the body metabolises the drug.

First Published: Sat, May 19 2012. 00:58 IST