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Apotex has dropped an antitrust lawsuit against eye care drugmaker Allergan that alleges the firm improperly obtained a patent to prevent generic competition on its anti-inflammatory eye drug Acular.
Purdue Pharma has filed its notice of appeal with the trial court that recently ruled that some of its patents for the powerful pain drug OxyContin (oxycodone) are invalid.
Eon Labs has started shipping the first generic version of GlaxoSmithKline’s (GSK’s) profitable antidepressant Wellbutrin SR (bupropion HCl extended release) in 100-mg strength tablets.
The FDA’s decision to award Alpharma subsidiary Purepac 180-day marketing exclusivity for a generic version of Pfizer’s epilepsy drug Neurontin (gabapentin) has been upheld by a federal appeals court.
Both brand and generic drug interests have urged the U.S. Supreme Court to review an appeals court decision that found a 1997 patent settlement agreement between generic firm Andrx and brand firm Aventis automatically violated antitrust laws.
The FDA’s draft guidance on pharmacogenomics that calls for voluntary genomic data submissions (VGDSs) needs more detail on how drugmakers’ proprietary interests would be protected, Eli Lilly told the agency in comments recently.
Drugmakers involved in potential off-label promotions of their products need to be wary of a new tactic used by prosecutors that has greater financial consequences than FDA enforcement activities under the Food, Drug and Cosmetic Act: prosecution under the False Claims Act.
The U.S. Supreme Court is considering whether to review an appeals-court decision that found a 1997 patent settlement agreement between generic firm Andrx and brand firm Aventis automatically violated antitrust laws.