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The reversal of a U.S. district court’s decision that dismissed a legal action brought by Teva Pharmaceutical to launch generic Famvir may have positive implications for generic firms taking moves to avoid at-risk launches, according to legal sources.
The fate of Mylan Pharmaceuticals’ 180-day marketing exclusivity period for its recent launch of generic Norvasc may be answered in a little more than two weeks, according to terms of a court order blocking other generic firms from marketing their versions of the drug.
House Oversight and Reform Committee Chairman Henry Waxman (D-Calif.) has taken an interest in the debate over how the FDA can approve follow-on biologics, holding a hearing on the issue featuring scientists from the pharmaceutical industry
Moving to minimize the effect of generic competition for its blockbuster hypertension drug, Pfizer plans to authorize the sale of its own generic Norvasc, the company announced last week.
Last week’s reversal of a district court ruling that blocked a challenge to a key Norvasc patent has triggered an early generic launch of the drug by Mylan Laboratories.
The Supreme Court is seeking advice from the U.S. government on whether it should review a federal antitrust lawsuit triggered by a reverse-payment deal that delayed the launch of generic tamoxifen.
Mylan Laboratories lost its bid to launch generic Topamax capsules and tablets after a federal court barred the company from selling its version of the epilepsy treatment prior to late 2008.
A federal appeals court has invalidated a key patent held by Pfizer for its blockbuster high blood pressure treatment Norvasc, the company said March 22.