AstraZeneca Loses Bid To Delay Generics Of Seroquel In US Market
26 Mars 2012 - 10:57AM
Dow Jones News
AstraZeneca PLC (AZN) has failed to delay generic versions of
its top-selling anti-psychotic drug Seroquel entering the U.S.
market.
The U.K.'s second biggest drug maker company had wanted to
prevent the U.S. Food and Drug Administration giving final
marketing approval to generic forms of Seroquel until December. But
its suit against the FDA, filed earlier this month, was dismissed
on Friday in Washington D.C. by a US judge who refused to grant
AstraZeneca an injunction, ruling that the group had failed to make
a clear case that it was entitled to one.
The ruling opens the way for doctors in the U.S. to switch to
prescribing cheaper generics of the medicine that will quickly
become available as Seroquel's protective patent expires
Monday.
The medicine maker filed its suit against the FDA earlier this
month in an effort to overturn an FDA ruling that generic copies of
the antidepressant would not have to carry the same warnings about
possible side effects -- including suicidal thoughts and high blood
sugar levels -- that were required of AstraZeneca.
Seroquel, AstraZeneca's second best-selling product, generated
$5.83 billion last year and is the first of its best-selling drugs
to lose U.S. patent protection.
AstraZeneca said Monday that it "continues to believe strongly
in the merits of its position and is evaluating its options."
But analysts believe AstraZeneca has little room for
maneuver.
"We see AstraZeneca's options as now limited, especially given
the speed of the court's decision," said Navid Malik of Cenkos.
Last week, AstraZeneca lost a battle in the U.K. High Court
which ruled that its patent on Seroquel is invalid in Britain. The
company had hoped to maintain revenues by placing a patent on an
extended release version. However, the UK court ruled the patent is
invalid following challenges from companies such as Teva
Pharmaceutical Industries (TEVA).
AstraZeneca faces one of the highest exposures to drug patent
expirations within the pharmaceuticals sector. Its blood-pressure
medicine Atacand loses protection this year while an ulcer drug
Nexium goes generic in 2014 followed by cholesterol fighter
Crestor, its best-selling product, in 2016.
AstraZeneca shares opened down Monday at at 0900 GMT were 0.2%
lower at 2,836 pence.
-By Sten Stovall, Dow Jones Newswires; +44 207 842 9292;
sten.stovall@dowjones.com