Teva Fails To Overturn €60m EU Fine Over Provigil ‘Pay For Delay’
Firm Had Contested 2020 Decision Stemming From Investigation That Began In 2011
Teva has failed in its attempt to overturn European fines totaling €60.5m in relation to a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil).
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Teva plans to begin appeal proceedings, the firm has told Generics Bulletin, after being fined €60.5m ($72m) by the European Commission over an historic “pay-for-delay” arrangement covering subsidiary firm Cephalon’s Provigil (modafinil).
Clear progress is being made in the European value added medicines sector, Medicines for Europe’s outgoing sector chair Arun Narayan has highlighted in an interview with Generics Bulletin. However, there is still more work to be done to ensure that the market is supported by imminent legislative and regulatory initiatives, to ensure patients’ access to continuous innovation for existing medicines.
Partners Apotex and Ambio have announced approval of a second US teriparatide generic from the FDA, adding another Forteo rival to the market and removing hopes that Teva’s recently approved first generic could benefit from 180 days of market exclusivity. Further competition is also in the works with Amphastar awaiting FDA action on a further teriparatide ANDA.