Mylan Seeking To Sell Generic Of Pfizer's Sutent Cancer Drug
May 13 2010 - 6:35PM
Dow Jones News
Mylan Inc. (MYL) has applied for U.S. regulatory approval to
sell a generic version of Pfizer Inc.'s (PFE) Sutent cancer pill by
challenging several patents on the drug.
In a regulatory filing Thursday, Pfizer said Mylan had notified
it of the challenge earlier this month. Mylan is challenging "on
various grounds" the Sutent basic patent, which expires in 2021,
and two other patents that expire in 2020 and 2021, Pfizer
said.
Last month, the Food and Drug Administration disclosed on its
Web site that a company submitted an application to market generic
Sutent, although the identify of the challenger wasn't known.
Sutent has been one of Pfizer's few successful new drugs in
recent years, generating $964 million in sales last year. Launched
in the U.S. in 2006, Sutent is approved to treat kidney cancer and
certain gastrointestinal tumors.
Being first to file a patent challenge, called a "Paragraph IV"
challenge, can be lucrative for a generic drug maker because it
provides 180 days of exclusivity if the move is successful.
Even if Mylan succeeds, a generic version of the drug likely
wouldn't make it to the market for years. Under the law, if a
patent owner sues a generic applicant for infringement within 45
days of that notice, approval of the generic is stayed for 30
months.
The automatic 30-month stay allows time for resolution of the
litigation, while protecting the patent holder from harm that could
ensue from the FDA granting marketing approval to a potentially
infringing product.
Officials from Mylan weren't immediately available for
comment.
Pfizer shares closed down 2% at $16.56 Thursday, and were up
three cents after hours.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com
(Peter Loftus contributed to this article.)
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