Aug 15 (Reuters) - Generic drugmaker Watson Pharmaceuticals
Inc sued the U.S. Food and Drug Administration,
challenging a ruling against Watson's generic version of a
big-selling diabetes drug, Actos.
Watson said that the FDA improperly denied the company's
shared exclusivity on the generic version despite Watson
directly following directions received from the regulator.
As a result of the FDA's decision, approval could be delayed
for up to six months, Watson said.
Watson planned to launch its generic version of Takeda
Pharmaceutical Co Ltd's Actos on Aug. 17 after a 2010
settlement with the Japanese drugmaker.
Takeda also granted licenses to Mylan Inc and
India's Ranbaxy Laboratories at that time to start
marketing generic Actos on Aug. 17.
The first company that files for approval of a generic
version of an off-patent drug typically gets marketing
exclusivity for 180 days.
During the 2010 settlement, Takeda said Mylan, Watson and
Ranbaxy were the first to file for generic Actos.
"We believe that we have sound arguments that refute FDA's
position and will seek the court's intervention to enable
approval," Watson CEO Paul Bisaro said in a statement.
An FDA spokeswoman said the agency would not comment on
Actos, which belongs to the same drug class as
GlaxoSmithKline's Avandia, h ad total U.S. sales of about
$2.7 billion for the twelve months ending May 31, Watson said,
quoting IMS Health data.
Watson said that it remains confident of achieving its
recently-disclosed forecast for 2012, even if the FDA does not
approve its generic Actos within the expected time frame, citing
improved market conditions for certain generic drugs and a
favorable FDA decision on another product.
Watson in July raised its 2012 earnings forecast to between
$5.65 and $5.85 per share, up from its prior view of between
$5.55 and $5.80.
The generic drugs industry, which has seen extensive
consolidation in the recent past, is expected to see big gains
as several top-selling pharmaceutical drugs lose their patent
protection and governments across the developed economies try to
cut down healthcare costs by focusing on cheaper generics.
Shares of Watson, which is acquiring Swiss generic drug firm
Actavis Group for at least 4.25 billion euros ($5.60 billion),
were down nearly 1 percent at $79.39 in morning trade on the New
York Stock Exchange on Wednesday morning.