Lek obtains marketing authorization for omeprazol

4. 2. 2003

A Slovenian pharmaceutical company, Lek Pharmaceuticals d.d., was granted by the US Food and Drug Administration (FDA) a final approval for the marketing of 10 and 20mg omeprazol capsules. The US market is the world’s largest pharmaceutical market and one of Lek’s strategic markets.

Omeprazol, the world’s second biggest blockbuster drug, is used for the treatment of gastro-intestinal disorders, particularly duodenal and gastric ulcers.

The originator AstraZeneca belongs to the group of top five global pharmaceutical companies, marketing its product under the registered trade mark Prilosec/Losec. The US sales of Prilosec in 2002 amounted to about USD 4 billion. The company KUDCo/Schwarz Pharma, the first generic manufacturer, launched the generic omeprazol in December 2002. KUDCo is the only generic manufacturer of the first group of the companies sued, having reached a favourable settment of the patent dispute at the court of first instance. Through its active role in the patent litigation, Lek, belonging to the second group of the generic companies sued, is proving that its product is patent non-infringing. Considering the complexity of the patent situation, the future of the product is unpredictable. Lek is also planning to obtain a marketing authorization in the EU.

Lek, which has developed its own, patent non-infringing formulation of the drug, has been marketing omeprazol in Slovenia for several years and in its traditional markets of Central-Eastern Europe and South-Eastern Europe.

For Lek, the successful conclusion of the registration procedure in the USA represents one of its major business achievements. “For Lek Group, omeprazol is of strategic importance, while its launching in the US market is one of the company’s key challenges for the future,” said Metod Dragonja, President of Lek Board of Management.