Yesterday’s Federal Court decision invalidating Pfizer’s Norvasc (amlodipine besylate) could give an early boost to Novartis’ Exforge.
“Besides the generic companies that will be launching their cheaper formulations of Norvasc, the other company that stands to benefit is Novartis,” Prudential analyst Tim Anderson wrote in a research note issued shortly after the decision.
Novartis has been holding off on launching Exforge, which combines Novartis’ Diovan (valsartan) with Norvasc in one pill, until September 2007, pending the expiration of market exclusivity and patent protection for Norvasc.
Exforge won FDA approval in December.
“The presumed Sept. ’07 launch could now be brought forward to March/April ’07, which is a slight positive for Novartis,” Anderson said.
The Court of Appeals for the Federal Circuit Thursday reversed a lower court’s ruling in favor of Pfizer in the company’s bid to prevent Canadian generics firm Apotex from launching a copycat version of Norvasc.
Mylan Laboratories, which was the first Norvasc Abbreviated New Drug Application filer, holds 180-day exclusivity rights for a generic version of the drug and could launch their version as early as next week.
Pfizer said in a statement that it disagreed with the yesterday’s ruling and is considering all its options, including “seeking reconsideration” of the decision.
Both Norvasc and Diovan are top-selling therapies in their respective categories.
Norvasc, a calcium channel blocker, had US sales of $2.6 billion in 2005, while Diovan, an angiotensin II antagonist, racked up 2005 sales of $1.04 billion, according to IMS Health.