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Sunday, October 24, 2010

[T.S.R:16105] Lupin settles dispute with Warner Chilcott



Warner Chilcott PLC said Thursday they will settle a pending patent lawsuit over Warner's birth control Loestrin 24 and Femcon FE with Lupin Ltd.


Financial details of the deal, which delays entry of generic competition to the drugs, was not disclosed. Such deals are sometimes called "pay-to-delay" because pharmaceutical companies pay generic competitors a sum in order to settle a patent challenge and delay market entry of the proposed generic drug.


In 2009, Lupin, based in India, asked the Food and Drug Administration to approve generic versions of the oral contraceptives.

Ireland-based Warner Chilcott ( WCRX - news - people ) said it started selling Loestrin 24 FE in March of 2006 and its patents on the drug expire in 2014. Meanwhile, it started selling Femcon FE in 2006 and a key patent for that drug doesn't expire until 2019.

Under the settlement, Lupin agreed it will not sell generic versions of Loestrin 24 prior to July 22, 2014, unless another company launches a generic version first. Meanwhile, Warner Chilcott granted Lupin a non-exclusive license covering Femcon Fe, which will permit Lupin to sell a generic version under certain circumstances.


On Femcon, Lupin is authorized to sell a version of Femcon FE in the U.S. either 180 days after Teva launches its version, as that company was the first to file, or Jan. 1, 2013.

Safe Harbor Statement:

Some forward looking statements on projections, estimates, expectations & outlook are included to enable a better comprehension of the Company prospects. Actual results may, however, differ materially from those stated on account of factors such as changes in government regulations, tax regimes, economic developments within India and the countries within which the Company conducts its business, exchange rate and interest rate movements, impact of competing products and their pricing, product demand and supply constraints.
 
Nothing in this article is, or should be construed as, investment advice.
 
 
 

 
 


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