Natco seeks US FDA nod for Tamiflu generic

Natco Pharma, the generics major, has challenged Gilead Sciences, the US bio-pharmaceuticals research company, on the patent issued for influenza drug Tamiflu.

According to a statement from Natco, the US Food and Drug Administration (FDA) has accepted its ANDA for generic Tamiflu (oseltamivir phosphate) capsules.

ANDA, or abbreviated new drug application, is an application for a US generic drug approval for an existing licensed medication or approved drug.

“Gilead will have to now respond to a notice issued by the FDA within 45 days. We will know the legal status of our application only after hearing from the innovator,” a Natco spokesman told DNA.

Gilead, which develops and commercialises molecules for various ailments including HIV, receives royalties on the drug sales from Roche. It is estimated that the drug has a market of about $1 billion.

Though used extensively in treating bird flu and swine flu, Tamiflu is also recommended for influenza in the US.

Anticipating a favourable outcome, Natco has also inked a deal with the Luxembourg based Alvogen IPCO for marketing and sales of its generic Tamiflu in the US. Though the details of the deal are not disclosed, it is believed that there is a revenue sharing arrangement between the two companies.

However, Natco claimed it has a first-to-file status on the drug. “Natco is the first to file an ANDA for the generic version of Tamiflu. Should the ANDA be approved, the company may be entitled to 180 days of generic market exclusivity,” it said.

Gilead, too, is reviewing the FDA notice and would decide on suing Natco in the next 45 days. In case Gilead sues Natco, the Hyderabad-based company would be barred from marketing the product for at least 24 months or until the case is decided in Natco’s favour.

Meanwhile, the patent on Tamiflu would expire in 2013, possibly encouraging the innovator and the challenger to come to an agreement without pressing for litigation.