By Peter Loftus
Of DOW JONES NEWSWIRES
The U.S. Food and Drug Administration has given permission to Indian generic-drug maker Lupin Ltd. (500257.BY) to seek approval for a generic version of Pfizer Inc.'s (PFE) blockbuster cholesterol drug Lipitor with a different formulation than the original drug.
The FDA decision, however, isn't likely to result in the introduction of the Lupin product anytime soon. Lupin still must go through the normal generic-drug approval process before it can launch its proposed capsule version of Lipitor--the original product is a tablet--and agency reviews can take upwards of two years.
New York-based Pfizer said in a written statement Thursday that it believes the FDA decision on Lupin's request has no effect on its prior Lipitor patent settlement with Ranbaxy Laboratories Ltd. (500359.BY), which is expected to keep generic copies of Lipitor off the U.S. market until November 2011.
A Lupin spokeswoman declined to comment.
Lupin is one of several generic-drug manufacturers eyeing a piece of what promises to be a big market opportunity. The original Lipitor is the top-selling prescription drug in the world, with $11.4 billion in global sales last year and $5.7 billion in the U.S. alone.
Lipitor's impending loss of U.S. market exclusivity will be a major financial blow to Pfizer, which has cut costs and diversified its business lineup in preparation.
In 2008, Lupin filed a citizen petition with the FDA asking for permission seek approval of the capsule version of Lipitor. Lupin said it wanted to market a capsule version for people who have difficulty swallowing a tablet or prefer a capsule form.
The FDA last week granted Lupin's request, according to a letter posted online by the agency. The agency said Lupin's proposed capsule version of Lipitor wouldn't pose questions of safety or effectiveness, since the uses and oral route of administration are the same as the original tablet.
A capsule typically has a gelatinous exterior with the active ingredient inside, sometimes in powder form. Currently, Pfizer sells solid-tablet versions of Lipitor, which is approved to lower cholesterol and reduce the risk of heart attacks.
Because Lupin's product would be a different formulation, pharmacies wouldn't be able to automatically substitute it for branded Lipitor prescriptions, Pfizer said. Instead, doctors would have to specifically prescribe the capsule version if they or patients wanted the Lupin product.
Pfizer has U.S. patents for Lipitor that expire this year and in 2011, 2016 and 2017. The company had sued Ranbaxy after Ranbaxy challenged the patents' validity, and in 2008 the companies settled their litigation. Pfizer granted Ranbaxy a license to begin selling generic Lipitor in the U.S. effective Nov. 30, 2011.
Other generic-drug companies have filed for FDA approval to sell generic Lipitor, and Pfizer has filed patent-infringement suits that are pending in U.S. courts. Under federal law, Ranbaxy is expected to have a 180-day period of exclusivity to sell a third-party generic Lipitor.
In addition, Pfizer has granted Watson Pharmaceuticals Inc. (WPI) exclusive rights to sell what is known as an authorized generic version of Lipitor in the U.S. for five years, beginning in November 2011. Pfizer will manufacture and sell Lipitor's active ingredient, atorvastatin, to Watson for use in the authorized generic product, the company disclosed in a recent regulatory filing.
-By Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com
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