According to Teva Pharmaceuticals, the company’s legal battle with GSK over “skinny labels” portends a greater threat to the generic drug market. Skinny labeling is a practice where a manufacturer can get its generic approved by applying for some of the original drug’s indications, but not all. GSK and others argue that the practice is infringement because the generics are often prescribed off-label for the original drug’s indications. Teva has asked the US Supreme Court to reverse the decision, which ordered the company to pay GSK $235 million.
According to , “Teva and GSK’s skinny label litigation saga has been roiling for years now. Teva launched its Coreg generic in two of the branded med’s three indications back in 2007. Four years after that, the FDA told Teva to add the med’s third indication for congestive heart failure, despite GSK holding a patent for that use through 2015.”
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(Source: Fierce Pharma, July 14th, 2022)