On 26 November 2010, generic drug maker Impax Laboratories announced that it is challenging the patent covering Abbott Laboratories’ cholesterol-treatment drug, Simcor (niacin/simvastatin).
Impax challenges Simcor patent
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Posted 25/02/2011
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Impax said it had filed an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of niacin/simvastatin extended-release tablets in 20 mg and 1000 mg strengths.
Impax’s application contained a paragraph IV certification, a legal assertion under the Hatch-Waxman Act of 1984 that the patent covering Simcor is invalid or unenforceable, or that Impax’s version will not infringe upon it. Abbott responded by filing a patent infringement suit on 24 November 2010 against Impax in the US District Court of Delaware.
Once the ANDA is approved by FDA, Impax intends for Global Pharmaceuticals, its generic division, to commercialise the product.
Niacin/simvastatin combination therapy is used to reduce cholesterol levels in patients with high cholesterol, especially in cases where treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate.
Annual US sales of Simcor extended-release tablets, 20/1000 mg, were approximately US$37 million (Euros 26.8 million) up to 30 September 2010.
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