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The FTC’s recent ruling that Schering-Plough and several generic firms forged anticompetitive pacts in the 1990s sends a message to drugmakers contemplating similar agreements, though some experts say such deals are no longer in favor in the industry.
The European Parliament last month voted to give brand firms up to 11 years of exclusivity on products before they would have to face generic competition, a move that European generic drug advocates say could delay generic entry but will also provide for a more efficient regulatory system.
In a move that could delay generic competition, Purdue Pharma has petitioned the FDA to withhold final approval for a version of its profitable pain drug OxyContin until generic firms implement appropriate risk management plans (RMPs).
The FDA has withdrawn its tentative approval for Barr Pharmaceuticals’ generic version of Bristol-Myers Squibb’s diabetes drug Glucophage XR because of concerns over the pharmaceutical ingredients used to make the product, the firm said Friday.
Pharmaceutical firms entering into settlement agreements over generic versions of brand drugs must now inform federal antitrust authorities once a deal is reached.
Connecticut is going to investigate possible anticompetitive actions by Purdue Pharma in seeking and maintaining patents for the painkiller OxyContin and wants other states to join the probe, according to a spokesman for state Attorney General Richard Blumenthal.
NaPro BioTherapeutics did not obtain its formulation patents for a generic version of paclitaxel through inequitable conduct and fraud, a federal court ruled late December.