Abbott sues to block generic form of TriLipix as drug questioned
Abbott Laboratories sued to prevent Impax Laboratories Inc. from selling a generic version of the cholesterol drug TriLipix until 2025.
Impax said in a statement it is seeking U.S. Food and Drug Administration approval to sell a copy of the delay-release capsules in the 135-milligram and 45-milligram dosages. Abbott and its Fournier Laboratories contend the copy would infringe a patent on the medicine, and sued Impax on March 12 in federal court in New Jersey.
TriLipix, which reduces cholesterol and fatty acids called triglycerides in the blood, had about $276 million in sales for the 12 months ended in January, Impax said, citing Wolters Kluwer Health. The drug, whose chemical name is choline fenofibrate, is a delayed-release version of Abbott's TriCor medicine.
Abbott, based in Libertyville Township, is relying on TriLipix to generate revenue as TriCor faces generic-drug competition. Teva Pharmaceutical Industries Ltd., the world's biggest generic-drug maker, could begin sales as early as March 2011 under a lawsuit settlement with Abbott.
The lawsuit against Impax is a standard part of the process to clarify patent rights before a generic drug enters the market. Under federal law, the FDA can't give final approval to Hayward, California-based Impax's application for 30 months unless a judge rules in the company's favor before then.
TriLipix to be studiedTriLipix also will be reviewed by U.S. regulators after an older version failed to lower the risk of heart attack and stroke more than a generic cholesterol pill in a study.The Food and Drug Administration said it will review data from the study once it becomes available, according to a posting on its Web site. The research, presented at a medical meeting yesterday, found no significant reduction in heart complications among patients taking simvastatin with Abbott's older TriCor cholesterol drug compared with those on simvastatin alone.The study, called Accord, looked at type 2 diabetics who were at an increased risk for heart disease. Patients shouldn't stop taking the medications without talking to their doctors, regulators said. TriCor and TriLipix, a delayed-release version, generated a combined $1.34 billion in revenue last year for Abbott."We expect FDA to eventually add the Accord data to the label but it's unclear to us at this time how the indication might change," said Larry Biegelsen, an analyst with Wachovia Corp. "We expect FDA's review to take at least a few months."The FDA hasn't made a conclusion about whether combining the generic cholesterol drug simvastatin with TriCor or Trilipix has benefits for heart patients, according to the agency's Web posting.Sales ProspectsThe findings and FDA review could hurt Abbott's prospects for generating $1 billion a year in sales for an experimental pill called Certriad, which combines TriLipix with AstraZeneca Plc's Crestor, said Biegelsen. He projects Certriad sales of $291 million in 2014 following the results.The study didn't specifically track patients with high triglycerides and low HDL, or good, cholesterol -- a targeted population for the drug. In a sub-analysis, people who had high triglycerides and low HDL appeared to benefit from TriCor, though the study wasn't designed to look at that group, researchers said. Patients taking TriCor typically have twice the level of triglycerides as those tracked in the study, Abbott said.Triglycerides are a type of fat that circulates in the blood and can lead to heart disease when found in excess in the body. HDL cholesterol is believed to help ferry artery-clogging LDL cholesterol out of the body, preventing plaque buildup.Simvastatin is from a class of cholesterol pills called statins, which work by blocking an enzyme that helps produce cholesterol in the liver. TriCor at the highest dosage costs $4.60 a pill, more than four times the price of generic simvastatin, according to Drugtore.com.Abbott shares fell 2 cents to $54.54 at 12:55 p.m. in New York Stock Exchange composite trading.