FDA approves Sun's generic Prandin
This article was originally published in Scrip
Sun Pharmaceutical Industries has received final approval for its ANDA for a generic version of Novo Nordisk's diabetes drug Prandin (repaglinide), paving the way for a launch of the product in the US.
Sun said that it would be eligible for 180-day marketing exclusivity in the US being the the first-to-file an ANDA for a generic version of Prandin.
Analysts expect significant sales for the generic version though specifics on the labeling details for the product were not immediately clear. Sun declined to comment on the labeling issue. Nimish Mehta, founder of Research Delta Advisors, told Scrip that assuming a 30-40% price erosion and no news yet of an authorized generic version, Sun should be able to garner sales of close to $25-30m from its generic Prandin during the exclusivity period. Prandin tablets 1mg and 2mg reported annual sales of about $200m in the US.
The FDA approval for Sun's generic comes after the US Court of Appeals for the Federal Circuit last month ruled that Novo Nordisk's claim 4 of its patent for the administration of Prandin with metformin – PrandiMet – was invalid as obvious (scripintelligence.com 24 June 2013). The court, though, reversed the decision by the US District Court for the Eastern District of Michigan that the claim on the patent – US Patent No 6,677,358 – was unenforceable due to inequitable conduct.
Last year, the US Supreme Court had, in a case concerning Sun's generic version of Prandin, held that generic firms may employ the so-called counterclaim provision of the Hatch-Waxman Act to force brand-name drug manufacturers to correct inaccurate descriptions of their medication's patent as covering a particular method of using the product (scripintelligence.com 19 April 2012).
Sun's US arm, Caraco, had earlier filed an ANDA for a generic version of Prandin, which had been approved by the FDA for the treatment of diabetes alone; in combination with metformin; and in combination with thiazolidinediones. Novo filed an infringement suit and Caraco submitted a section viii and a proposed labeling carving out Novo's patented use of Prandin with metformin. Novo's patent for the compound expired in 2009 but in 2004, the Danish company had also acquired a method-of-use patent for the drug, the '358 patent, for the administration of Prandin with metformin that expires in 2018.