New Delhi: Mumbai-based pharmaceutical firm Lupin is gearing to tap opportunities to the tune of up to USD 200 million in the US oral contraceptives market, despite patent litigation from rivals on its plans to sell generic drugs there.
"The oral contraceptives (OCs) market in the US is valued
at around USD 4 billion and growing at around 10 per cent
annually...This is a segment where it makes sense to have a
complete basket of products so that one can drive serious
value into the market and Lupin would be one of the few
innovators to drive it in," Lupin Group President and
Executive Director to the Board Nilesh Gupta told a news agency in an
emailed interview.
The company has filed four more abbreviated new drug
applications (ANDAs) with the US Food and Drug Administration
(USFDA) to sell the generic version of several OCs bringing
its total current filing number at 11.
The company plans to file another 10 ANDAs in the next
6-7 months. It expects the first approval by 2011-12 -- the
time it can enter the US market.
"Over the years to come there is no reason to believe
that it (OCs) would not account for USD 100–200 million for
Lupin," Gupta said.
When asked about rivals filing patent infringement
litigation, the most recent being Teva Pharmaceuticals filing
a patent suit against Lupin for its ANDA for generic version
on 'Seasonale' and also by Warner Chilcott for Losetrin Fe and
Fencon Fe, he declined to comment.
"As a policy Lupin would not like to comment on any
ongoing litigations," Gupta said.
He, however, said the company would go ahead with its
constant strategic focus on addressing niche therapy areas,
developing differentiated difficult-to-develop and replicate
niche control release generic products and build IPR by
focusing on Para IV filings (which gives a company 180-day
exclusive marketing rights).
The company has already set up a dedicated OC
manufacturing unit at Indore with an investment of about Rs
150 crore.
Bureau Report
First Published: Sunday, October 11, 2009, 20:36