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Dr Reddy's sees approval of Prozac version

Indian drugmaker Dr Reddy's Labs said on Thursday it expects to win approval for its generic version of Eli Lilly's antidepressant Prozac after a court ruled in favour of a competing generic producer.

US generic drug maker Barr said on Wednesday a court of appeals panel upheld an earlier decision allowing it to market its copycat version of Prozac. Dr Reddy's is also fighting in a US court for the right to market its version in the United States.

Dr Reddy's Laboratories Chief Executive G V Prasad told Reuters in an interview he expected to get six months' exclusive marketing for one 40 mg dosage of fluoxetine, the key ingredient in Prozac, which is different from the dosage Barr has been permitted to market.

"Our case is pretty much the same as Barr's," Prasad said. "Fluoxetine should drive US generics growth for Dr Reddy's."

Prasad did not make any estimates for sales of Dr Reddy's version of Prozac, but analysts have projected Barr will sell $400 million of generic Prozac in fiscal year 2002 (July-June).

Pharmaceutical Resources Inc will market Dr Reddy's version of Prozac through its Par Pharmaceutical division, Prasad said.

GENERIC EDGE

In April, Dr Reddy's became the first Indian drugmakers to list in the United States, one of its key markets.

India's drug market is dominated by generic producers.

Prasad said his company sold drugs worth Rs 1.4 billion ($29.8 million) in the United States in the year to March 2001.

Prasad said Dr Reddy's Labs had so far filed for permission to market 13 generic drugs in the United States, including six in the last year.

He said four drugs had been launched and the US Food and Drug Administration tentatively approved two others.

On Wednesday, Dr Reddy's reported a net profit of Rs 1.34 billion on sales of Rs 8.99 billion for the year ended in March. Almost half the sales came from exports.

On Tuesday, Dr Reddy's announced it had licensed a diabetes drug it had discovered to Swiss giant Novartis for up to $55 million plus royalties.

Prasad said there could be an upfront payment in the current quarter to June, but declined to give details.

"Qualitatively doing a deal with Novartis was very exciting for us," he said. "It is a recognition of Dr Reddy's science."

Dr Reddy's has already licensed two other diabetes drugs to Danish firm Novo Nordisk.

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