White-hot rivalry to curb gains from generic Seroquel

Cut-throat competition is seen limiting the opportunity on blockbuster anti-psychotic drug Seroquel, the patent on which expired on March 26 in the US.

The drug, innovated by UK-based AstraZeneca, is used to treat schizophrenia, depression and bipolar disorders. It had sales of $4.4-4.6 billion last year, accounting for over 15% of the company’s sales —- its No. 2 drug behind cholesterol treatment Crestor.

As many as 8-10 players are seen mounting bids to tap the huge generic opportunity on Seroquel following the patent expiry, according to analysts.

These include entries from US-based Mylan and Israel’s Teva, besides Indian firms Dr Reddy’s Laboratories, Sun Pharmaceuticals, Lupin and Aurobindo Pharma.

Mylan and Teva have, in fact, announced that they are starting commercial launch of quetiapine fumarate tablets.

Interestingly, there is no clarity yet on which generic maker holds the first-to-file, or FTF, status on Seroquel, a status which could have earned the player 180 days of exclusivity to market the generic version in the US.

Competition is therefore expected to be intense.

And this, in turn, could limit the sales opportunity for the players, said Bhavin Shah, analyst, Dolat Capital.

A Morgan Stanley report pegged the price erosion for Seroquel at a whopping 96-97% following the patent expiry and launch of generic products. This would earn the Indian players a market share of about 10-12% and sales of $15-17 million, it said.

An analyst at another brokerage estimated the opportunity at $40-50 million apiece for the companies.