Lek Enters the U.S. Market with Co-Amoxiclav

The originator, GlaxoSmithKline, markets its product under the trademark Augmentin. The annual sales of Augmentin in the U.S. amount to $1.3 billion. Co-amoxiclav is available on the market in only limited amounts because of its complex production process, both concerning the technology and intellectual property rights. In addition to the originator, there are two other generic manufacturers present on the market since July of last year: the American company, Geneva, with its generic co-amoxiclav, and an Israeli company, Teva, which began to market its co-amoxiclav tablets less than a month ago. A marketing authorization for co-amoxiclav tablets has also been received by an Indian company, Ranbaxy, but their product is not yet available on the U.S. market.

The product is protected by a large number of patents which limit generic competition. The originator, GlaxoSmithKline, has filed lawsuits against all generic manufacturers of co-amoxiclav who have obtained U.S. marketing authorizations for the product. In the lawsuits, GlaxoSmithKline alleges that the generic companies illegally obtained the strain for the production of clavulanic acid.

The Slovene pharmaceutical company, Lek d.d., has, however, developed an independent strain for the production of clavulanic acid in its research laboratories in cooperation with external associates who are internationally recognized experts. In a court dispute, Lek is now proving its own, independent development of the product claiming that the lawsuit is entirely unfounded. The business risks are managed with a sufficient critical mass of resources within the Novartis Group.

Lek d.d. began its co-amoxiclav project in 1989 with its own research and development efforts, developing its own technology for the production of clavulanic acid and its own finished forms of co-amoxiclav which are in compliance with international regulatory requirements. Lek d.d. is producing the active ingredient, clavulanic acid, in its plant in Lendava and the finished product in Prevalje.

Co-amoxiclav is Lek’s most internationally distributed product which, to date, has become established in the markets of Poland, Croatia, Romania, the Russian Federation, the EU nations, as well as in Asian, African and Latin American countries. Lek is marketing its product in over 60 countries.

The consolidated sales of co-amoxiclav in the U.S. market are expected to exceed $100 million in 2003 making the U.S. Lek’s biggest market.

Disclaimer

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