Company: Abbott Laboratories
2010 U.S. sales: $1.015 billion/$1.582 global (includes TriLipix)
Impact: 6.68% of U.S. sales
Patent expires: July 2012
When Abbott Laboratories finally loses patent protection on TriCor, the drug may have set the record for exclusivity. It has been covered by one patent or another for more than 35 years, thanks to some formulation shifts and other changes Abbott made. In one case, Abbott avoided a patent challenge from Teva by converting TriCor to a tablet from a capsule, making the Israeli company's copycat form no longer bioequivalent.
The company was so successful at keeping TriCor's sales protected, it drew the spotlight from state and federal antitrust regulators, not to mention cornering-the-market allegations from Teva. Abbott agreed to pay $184 million to settle antitrust allegations, but denied any wrongdoing.
TriCor's patent life now is coming to an end. Luckily for Abbott, it has a successor drug, TriLipix, a delayed-release form analysts believe will siphon off about half of TriCor's patients by the time exclusivity ends. The only trouble is that some recent data suggest these two fenofibrate drugs aren't better at protecting diabetics against heart attack or stroke than generic simvastatin on its own. An FDA panel recommended the data be added to TriLipix's label, but it's unclear whether the study will have any impact on sales.