Genpharm gives up omeprazole exclusivity rights
Toronto-based Genpharm, the Canadian generics affiliate of Merck KgaA, has relinquished its 180-day marketing exclusivity rights to its 10 and 20mg generic omeprazole product and has entered into agreements with Schwarz Pharma's subsidiary Kremer's Urban Development Co. (KUDCo), and Florida-based Andrx Pharmaceuticals to clear the way for a possible launch of a non-infringing generic omeprazole product.
Toronto-based Genpharm, the Canadian generics affiliate of Merck KgaA, has relinquished its 180-day marketing exclusivity rights to its 10 and 20mg generic omeprazole product and has entered into agreements with Schwarz Pharma's subsidiary Kremer's Urban Development Co. (KUDCo), and Florida-based Andrx Pharmaceuticals to clear the way for a possible launch of a non-infringing generic omeprazole product.
Under the terms of the agreements, both Genpharm and Andrx have relinquished their six-month co-marketing exclusivity. Following this relinquishment the FDA has given final marketing approval for KUDCo's 10 and 20mg omeprazole product. KUDCo will share a percentage of its profits, split equally between Andrx and Genpharm, reducing from 30% to 18% to 12.5% over a period of time. The agreements follow a recent US District Court decision whereby KUDCo's product was found not to infringe any of Astra Zeneca's US patents relating to omeprazole.
However, AstraZeneca has now carried out an initial detailed review of the US Court's 11 October opinion and believes the Court 'made reversible errors in determining key facts and applying the law'. AstraZeneca has therefore decided to appeal against the portions of the judgement relating to KUDCo and Schwartz Pharma.