Mumbai: Sun Pharmaceutical Industries Ltd said on Friday that it had received final approval from the US Food and Drug Administration (FDA) to sell the generic version of Novo Nordisk’s anti-diabetic drug Prandin in that country.
Sun Pharma will have six-month market exclusivity since it was the first to file the generic drug application. One of the US subsidairies of Sun Pharma will sell 1mg and 2mg tablets of repaglinide, the generic ingredient of Prandin, in the US.
These doses of Prandin had annual sales of approximately $200 million in the US last year. Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
Six-month market exclusivity is given to drug makers that first file the abbreviated new drug application (ANDA)—documents seeking approval for launching a generic version of a patented drug after the expiry of the original patent—as an incentive for the first introducer of a low-cost generic version in the US market. Such applications are known as Para IV filings. Generic drugs help patients save on costs—they are typically at least 60% cheaper than the innovator’s brand.
Sun Pharma shares ended 1.20% higher at Rs.1,108.25 apiece on BSE. Analysts predict a substantial revenue boost in the second quarter of fiscal 2014 due to the launch of the Prandin generic.
More generic companies will enter the market upon the expiry of the exclusivity period and the price of the drug will start eroding substantially.
Danish drugmaker Novo Nordisk had sued Sun Pharma’s US subsidary Caraco Pharmaceutical Laboratories Ltd for patent infringement when the latter submitted its ANDA for the generic version in 2005.
In Jan 2011, a US court held the patent on the drug invalid. But Novo Nordisk appealed against this in the US Court of Appeals.