Lek enters the US market with enalapril
Ljubljana, 23 August – Upon the expiration of a 6-months’ exclusive pediatric right for enalapril, the Slovene pharmaceutical company Lek obtained a registration certificate for this drug in the USA. The US market is the largest global pharmaceutical market and one of Lek’s strategic markets. Enalapril belongs to the best sold drugs in the US market. In 1999, before the expiration of the patent for enalapril held by the American pharmaceutical company MSD, the sales volume of enalapril in the US market reached almost one billion dollars.
In conformity with its strategic orientation, Lek yesterday obtained the registration certificate for the drug enalapril in the USA. In co-operation with a US distributor, Lek will be marketing four forms of enalapril in this market. The drug is used in hypertensive patients.
Enalapril is one of the best sold drugs in rhe US market. In 1999 the sales volume of enalapril in the US market reached almost one billion dollars.
The patent for enalapril, held by the US pharmaceutical company MSD, expired in February, yet a 6-month renewal of the exclusive right for the use in children was granted by the Food and Drug Administration (FDA). The renewed right expired yesterday, 22 August. A green light was thereby given to Lek’s enalapril in the highly competitive US generic market. Sales of the drug enalapril have already started.
The timely acquisition of the registration certificate for the finished enalapril products in the US pharmaceutical market is another proof of Lek’s meeting the strict US requirements imposed on the pharmaceutical industry. Lek is thus implementing the set guidelines and its strategic objectives, thereby consolidating its position in a highly demanding and competitive US generic market.