Alphapharm's Attempt To Force Listing of Celexa Patent Rejected By Court
This article was originally published in The Pink Sheet Daily
Federal judge affirms FDA's "ministerial" role in declining to list certain patents in the "Orange Book." Forest said the patent should not be listed because it claims an intermediate of citalopram.
You may also be interested in...
Commissioner says agency will modernize drug patent reference manual this year and consider potential changes to Orange Book administration policy. However, any transformative moves could trigger a court challenge.
Forest attributes the majority of Celexa’s $15.4 mil. sequential quarterly sales growth to a 4% price increase taken in March. Forest’s estimates put the Celexa revenue run rate in early 2005 at $680 mil., above earlier predictions.
Company sees "no impediments" to ANDA approvals for antidepressant, beyond demands on FDA resources to review multiple applications simultaneously. Forest believes the agency will try to approve all generics simultaneously, making it difficult to complete the reviews before the end of the year.