$4.7 bn Novarsc generic goes out of bounds, but Matrix Labs is grinning

MUMBAI: The US Food and Drug Administration’s (FDA) decision not to grant immediate approval to fresh generic versions of Norvasc, the $4.7-billion hypertension drug developed by Pfizer, is a big setback to India’s copycat drugmakers.

Four of them — Aurobindo Pharma, Sun Pharmaceuticals, Orchid Pharmaceuticals and Zydus Cadila — had sought to market the generic version of Norvasc (amlodipine besylate) to the FDA.

On March 23, US-based generics maker Mylan Labs won 180-day marketing exclusivity after a US court invalidated Pfizer’s patent.  It launched the generic in the US on the same day. On March 26, Mylan appealed to the District of Columbia to stop the FDA from immediately approving other applications for amlodipine besylate products. That is, stall Indian rivals.

The court ordered FDA to announce its final decision on further Norvasc generic approvals.

Responding through a ltter, the FDA said it has decided not to approve generic versions other than Mylan’s at this time. “All unapproved ANDAs are currently blocked by Pfizer’s pediatric exclusivity,” the FDA said.

A Sun Pharma spokeperson refused to comment.

It is not clear whether the Indian companies will challenge the FDA decision. An analyst said the move will have a negative impact. “Getting exclusivity is more important. Once the exclusivity period is over, all generic companies will throng the market and prices will tumble as much as 90%,” he pointed out.

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