Abbott and Fournier agree to pay $22.5 million for blocking generic fenofibrate

Makers of the popular cholesterol-lowering drug TriCor have agreed to pay $22.5 million to resolve allegations that they illegally kept generic versions off the market. As a result of these practices, consumers and state governments paid higher prices for the cholesterol drug.

Under the agreement, Abbott and Fournier will pay $22.5 million to the states. North Carolina's share of nearly $800,000 will go to the state's Medicaid program, a joint federal-state program that provides health insurance for the poor. TriCor is a brand-name prescription drug that uses the active ingredient fenofibrate to regulate trigyliceride and cholesterol levels.

Cooper and the other attorneys general allege that since 1998, Abbott and Fournier have successfully monopolized sales of fenofibrate drugs by blocking generics from the market. The companies crafted elaborate schemes like filing multiple patents with the Federal Drug Administration and then filing patent infringement lawsuits to delay generic versions of TriCor. The attorneys general also contend that Abbott and Fournier thwarted competition by making various clinically insignificant changes to the dosage and form of TriCor and manipulating the drug codes used to create generic substitutions. Under the settlement, Abbot and Fournier have agreed not to delete the drug codes for the latest version of TriCor in the event a generic manufacturer seeks FDA approval of a generic version of the drug.

Oscient and Ethypharm receive paragraph IV notification from Lupin for Generic fenofibrate

Oscient Pharmaceuticals Corporation and its licensor, Ethypharm SA, have received notice of a Paragraph IV certification on behalf of Lupin Limited, advising of the submission of an ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg doses. The notice alleges that U.S. Patent No. 7,101,574, owned by Ethypharm, exclusively licensed to Oscient and listed in the FDA Orange Book for ANTARA, is invalid and/or will not be infringed by Lupin's manufacture, use or sale of the product for which the ANDA was submitted. U.S. Patent No. 7,101,574 is set to expire in 2020. Oscient and Ethypharm have 45 days to commence a patent infringement lawsuit against Lupin that would automatically stay, or bar, the FDA from approving Lupin's ANDA for up to 30 months or until a district court decision in its favor, whichever may occur earlier. Oscient and Ethypharm are currently in the process of evaluating the notice from Lupin and intend to pursue all available legal and regulatory options in defense of ANTARA, including enforcement of their intellectual property rights.

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