ADDERALL XR PATENT LITIGATION DELAYED
Shire said recently that the trial for its patent suit against Barr Laboratories
over attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR had been
delayed, which may give Shire more time to promote its abuse-proof Adderall
XR follow-on, NRP104, without generic competition. Adderall XR is Shire's top-selling
drug, with 2004 sales of $606.7 million.
British drugmaker Shire said the court had continued a recent pre-trial conference
until March 10, 2006, and had not set a trial date. The Shire-Barr trial —
initially scheduled for January 2006 — could be delayed well into next
year, and a ruling seems unlikely before the end of 2006, analysts said, giving
Shire more time to steer patients to NRP104.
With NRP104, Shire and drug development partner New River Pharmaceuticals aim
to tap a growing market for abuse-proof ADHD stimulant drugs. ADHD stimulant
drugs are abused recreationally and also by students who take them to enhance
concentration. Study results unveiled recently confirmed that NRP104 is more
abuse-proof and overdose-proof than other amphetamine-based ADHD therapies like
Adderall XR (amphetamine aspartate/ amphetamine sulfate/dextroamphetamine saccharate/dextroamphetamine
sulfate).
Moreover, any deal Barr strikes with Shire is also likely to delay generic competition
beyond 2006, analysts said. Such a delay could boost Shire's earnings per share
64 percent to 67 cents a share, Merrill Lynch analyst Graham Parry writes in
a recent note.
Shire has also thrown up other hurdles to generic competition by suing rivals
for infringing on its newest patent, and filing a citizen petition with the
FDA requesting that any abbreviated new drug applications show "exact bioequivalence"
to Adderall XR, notes Merrill Lynch analyst David Munno.
In a more negative scenario, however, Barr could cut a deal with Impax or another
generic drugmaker that has also filed to market a version of Shire's drug, if
that drugmaker wins its case against Shire. Impax's trial is set for February
2006. Barr could also launch generic Adderall XR at-risk before the trial begins.
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