The product is a generic version of Novo Nordisk’s Prandin (repaglinide), which is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type-2 diabetes mellitus. Annual sales of Prandin are approximately US$250 million, according to Symphony Health Solutions.

Tentative approval by FDA enables generics access to poor nations, where generics are often the only drugs that are affordable for patients. This comes about via a US initiative, which allows sale of generics to treat conditions where there is a significant public health impact, even though the originator drugs are still under patent protection.

Perrigo’s Chairman, President and CEO, Mr Joseph C Papa said of the approval that ‘this is another example of Perrigo’s commitment to bring new products to market and deliver on its mission to provide quality, affordable healthcare to consumers.’

Novo Nordisk has two patents protecting Prandin, one of which (U.S. RE 37,035), already expired in March 2009. The second patent (U.S. 6,677,358), which includes combination product and method claims for using repaglinide and metformin, is set to expire on 12 June 2018.

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