*October 5th, 2010*

Dr Reddy’s Laboratories is likely to see a major upside coming its way in
the form of olanzapine, a drug to treat schizophrenia and bipolar disorder.

Currently being marketed under the brand Zyprexa by Eli Lilly, the drug is
seen having sales of $1 billion.

Eli Lilly has the patent for it now, but this would expire in 2011, and
Reddy’s is expected to launch it in the fourth quarter next year.
Officials at Dr Reddy’s did not provide the exact gameplan for approaching
the market, a company spokesman told DNA Money:

“We anticipate approval during financial year 2011-12. We expect to be sole
first-to-file company for the 20 mg dose.”

Analysts say Zyprexa can be a major revenue earner for Dr Reddy’s.

Sameer Baisiwala and Saniel Chandrawat, analysts with Morgan Stanley, in a
note on September 13 said there will be two players in the US by fiscal
2012, selling olanzapine.

Reddy’s, since it will be selling the generic version, will see a price
discount of about 40%. Yet, the the market would be worth about $500
million.

A first-to-file company gets to sell a generic exclusively in the US for 180
days or six months. That would give Reddy’s about 50% market share in that
period.

However, by fiscal 2013, about 7-8 players are likely to enter, which could
cut the price by 90% due to which the total market value of olanzapine gets
slashed to $84 million.

Reddy’s has been working on challenging the patent held by Eli Lilly.

In 2009, a UK appeals court had upheld the validity of Eli Lilly patent for
Zyprexa and rejected Dr Reddy’s contention that an earlier Lilly patent
rendered patent for the blockbuster drug for schizophrenia invalid.

Reddy’s had argued that a disclosure for a prior Lilly patent for a broad
class of compounds included the one used in Zyprexa, meaning that the
subsequent patent for the schizophrenia drug lacked novelty.

However, the court had shot down the argument.

However, going by the data on the company’s pipeline and the channel checks
by the research firms, the generic launch of Zyprexa 20 mg is going to be
one of the biggest exclusivity opportunities Reddy’s would have in the near
future.

“There are other shared market opportunities coming in the way of DRL. But
Zyprexa would be one of the biggest exclusive launches the company has seen
so far,” a source tracking the sector said.

http://www.dnaindia.com/money/report_for-reddy-s-zyprexa-is-a-half-billion-opportunity_1447740

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