Indian generic drug makers, such as Ranbaxy, Lupin, Dr Reddy's and Aurobindo, which often opt to challenge patents in the US, might have to wait longer to launch their generic versions there.
For the next few years, the US Food and Drug Administration (FDA) has extended the timeline by 10 months for granting tentative approval to generic drug applications filed under Paragraph IV of its rules, seeking 180 days of marketing exclusivity.
A Paragraph IV filing is made when the generic applicant believes its product does not infringe the innovator's patents or such patents are not valid or enforceable.
The FDA, under a recent amendment to the Food and Drug Administration Safety and Innovation Act, has increased the timeframe for giving a tentative nod to such applications filed between January 1, 2010 and July 9, 2012 to 40 months from the earlier 30 months.
Generic drug makers are required to forfeit their exclusive marketing rights for the product in case they fail to secure tentative approval for their drug within this period.
According to an industry source, the move is not limited to applications filed between January 1, 2010, and July 9, 2012. "For applications whose 30-month stay expires between October 2015, and September 30, 2016, the 30-month period will be extended to 36 months," the source says.
The move has raised fear among domestic pharma companies, most of which have a strategy to challenge patents. Industry officials and analysts believe an extended time period for approval would mean a delay in the launch of their generic drug, which might lead to loss of exclusive sales of low-cost versions.
That apart, companies are also worried that even if they win a case in the US courts against the innovator company, they would not be able to launch the product if it is not approved by the regulator.
When a company files a Para IV generic application and the latter is challenged by the innovator, the court gives a stay on the product for 30 months. The generic company may launch the product if the court rules in favour of it. Besides, the company can also launch the product at risk after this 30-month period is over if it manages to get approval from the FDA. However, to retain 180 days of exclusive marketing rights on the product, the company has to get a tentative approval from the USFDA within 30 months, now extended to 40 months, for applications filed within the window specified.
"Companies generally file Para IV applications close to patent expiries. With this delay, companies would run a risk of reduction of the exclusivity period, as the patent may get expired in between, allowing other generic players to enter the market," a senior pharma research analyst said.
Though temporary, the move is significant because of the patent cliff during this period (starting 2010 to 2015), allowing a maximum of generic penetration mainly in developed markets like the US. So, most numbers of Para IV generic applications are expected to be filed during this period.
However, in some cases, generic drug makers could also benefit from the extension of the time frame. "Now that they have more time, it abates the risk of marketing exclusivity forfeiture in case their generic filing doesn't get a tentative approval within 30 months of being sued by the innovator," says Praful Bohra, senior research analyst, Nirmal Bang.
He cites the example of Ranbaxy, sued by many companies in the past, to forfeit marketing exclusivities on generic versions of drugs such as Nexium and Diovan.
According to the FDA, their latest move is due to a huge backlog of generic applications pending with it. The amendments to the Act have also allowed levy of a fee on generic drug applications and facility inspections, to garner resources to improve the pace of the system.
According to the source, the time frame would be gradually phased back to 30 months as the FDA eliminates the backlog of generic filings. According to Bohra, pending generic filings are estimated at 2,500.
