Lek files documentation for the acquisition of the marketing authorization for the drug omeprazol in the USA

21. 6. 2000

Ljubljana, 21 June – The Slovene pharmaceutical company Lek d.d. is one of the first pharmaceutical companies of the Central and Eastern Europe to have started marketing its finished pharmaceutical products in the US market; moreover, Lek is also marketing its pharmaceutical active ingredients in the USA. The US market is the world’s largest pharmaceutical market and one of Lek’s strategic markets. This is why Lek will continue to market its strategic products there.

In line with its strategy, Lek has filed the documentation for the marketing of the drug omeprazol in the USA. Omeprazol is used in the treatment of gastric disorders, mainly of the duodenal and gastric ulcer.

The sales of omeprazol amount to more than 6 billion US dollars, which ranks the drug among the best-selling pharmaceutical products worldwide.

AstraZeneca, one of the five largest pharmaceutical companies, owns the majority of patents for this drug. They are related to the manufacturing process, administration and form of the drug.

The basic patent for omeprazol by AstraZeneca expires in April 2001, but there are also other patents for this drug, their protection expiring gradually in the time period till February 2014.

The US regulations on drugs give the generic pharmaceutical companies an opportunity of a 6-months’ exclusive right to the sales of a generic product in the market, if the company concerned proves not to infringe the originator’s patents, or if it contests the patents.

At the moment, 7 generic pharmaceutical companies, including Lek, are striving to get the right to sell omeprazol in the US market. AstraZeneca, the originator, started legal actions against all of them.

Lek has developed its own patent-independent drug formulation, and will be proving in court that it is not infringing the patents expiring after April 2001.

There are several scenarios of coming on the US market, depending on the time of the acquisition of the registration certificate and on the outcome of the legal actions brought against the above mentioned generic companies.

Lek is already marketing omeprazol in some of its key markets, while for Lek, a successful ending of the registration and patent procedures in the USA would be one of the major business and marketing achievements.