Pill drill

Mumbai, Dec. 27: Dr Reddy’s Laboratories (DRL) has bagged a 180-day marketing exclusivity for Ondansetron Hydrochloride tablets in the US.

The drug, a generic version of GSK’s Zofran tablets, is used to prevent nausea associated with cancer treatment.

The US Food and Drug Administration (USFDA) has given its final approval to DRL for the abbreviated new drug application (ANDA) of Ondansetron Hydrochloride tablets of 4mg, 8mg, 16mg and 24mg.

The Hyderabad-based company has informed the stock exchanges that as it was the first company to file an ANDA containing a paragraph IV certification for the product, it has been awarded 180 days of marketing exclusivity.

G.V. Prasad, vice-chairman and CEO of DRL, said: “We are pleased with the final approval of our generic version of Zofran with 180 days of marketing exclusivity. With six product introductions to date in the current year, we are making progress in building a sustainable base generics business with potential upsides in the US in the medium term. This reaffirms our commitment to developing one of the largest pipelines in the US generic industry.”

According to DRL, the brand product has annual sales of around $639 million.

Though the company did not comment on the amount it would rake in from the six-month marketing rights, analysts expect revenues from the drug during this period to be up to $100 million.

DRL officials said besides adding to its topline, the generic version of Zofran would enhance its presence in the US markets.

This year has been good for DRL. It crossed $1 billion in global sales and clinched some deals. It has entered into an authorised generics pact with US-based Merck to sell generic versions of heart drug Zocor and Proscar that is used to treat prostate disease. It has also acquired Betapharm of Germany for $570 million.

However, DRL is not the only one to reap benefits from Ondansetron. Wockhardt Ltd’s US subsidiary has launched Ondansetron injection in the US.

“This is Wockhardt’s eighth product approval from USFDA in 2006 and the third injection product in the US market,” said company chairman Habil Khorakiwala. He added that the company now markets 15 products in the US and of these, 10 were launched this year.