Genpharm gives up its exclusivity rights

Published: 1-Dec-2002
Regulatory


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 Kremer's Urban Development Co. (KUDCo) and Florida-based Andrx Pharmaceuticals 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 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 AstraZeneca's US patents relating to omeprazole.

However, AZ has now carried out an initial detailed review of the opinion and believes the court 'made reversible errors in determining key facts and applying the law', and has decided to appeal against the ruling.

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