Lek's Omeprazole in the US Market

21. 8. 2003

Novartis has taken a decision on Lek’s launching a generic omeprazole in the US market this week.

In the beginning of February 2003 Lek d.d. obtained from FDA (Food and Drug Administration) final approval for the sales of generic 10- and 20-mg capsules of omeprazole. The US market is the world’s largest pharmaceutical market and also Sandoz’ largest strategic market.

Omeprazole is the world’s second-largest-selling pharmaceutical product. The originator AstraZeneca ranks among the world’s top five pharmaceutical companies. It markets its products under the registered trade mark Prilosec/Losec. The US sales of Prilosec in 2002 reached around USD 4 billion. The first generic manufacturer, the company KUDCo/Schwartz Pharma, launched its generic omeprazole in December 2002.

Lek, having developed its own, patent-free formulation, has been marketing omeprazole for a number of years in Slovenia and in its traditional markets of Central, Eastern and South-Eastern Europe. Generic omeprazole for the US market is being produced in the Ljubljana production plant. Marketing activities have been undertaken by Lek associated company Lek Pharmaceuticals, Inc., under Lek label.

“We believe there is significant interest in providing physicians and their patients with high-quality alternative to currently available products,” said Christian Seiwald, CEO of Sandoz.

Metod Dragonja, CEO of Lek, said:” Lek invested a large amount of know-how in this project. With substantial co-operation and support from the Sandoz company, we succeeded in launching the product in the world’s largest generic market.”