Ranbaxy Laboratories has launched the generic version of GlaxoSmithkline's blockbuster antibiotic, Augmentin, in the US.
Ranbaxy is the fourth company to have launched the generic version of the $2-billion-a-year drug in the US market, the other three being Israel's Teva Pharmaceuticals, Geneva Pharmaceuticals, a subsidiary of Novartis, and Slovakia's Lek Pharmaceuticals.
A Ranbaxy spokesperson confirmed that the company had launched the drug in the US last week. Analysts say Augmentin will give a big push to the company's global sales in 2003, just like the generic version of GlaxoSmithkline's cefuroxime axetil boosted the company's performance last year, with sales crossing $115 million.
Ranbaxy has already managed to grab 90 per cent of the US market with the Ceftin clone. After the launch of Augmentin, Ranbaxy is now gearing up to launch the generic version of the Roche's anti-acne drug, Accutane, in the US by the end of the quarter.
Augmentin is a $2 billion drug in the US and clocks about $3 billion globally. Although company officials were tightlipped on sales forecasts, analysts said the company could hope to garner sales of $30 million in the first year itself.
Ranbaxy received US Food and Drug Administration approval for 875 milligram and 25 milligram tablets of amoxicillin and clavulanate potassium on September 18, 2002.
Analysts said Ranbaxy would have to devise an aggressive strategy for capturing a fair share of the pie as it would have to counter competition from the other three players that have already entered the market.
While Geneva started marketing the generic in July last year, Israel's Teva entered the market in October 2002. Lek received the FDA nod for the drug in November last year and hit the market with the drug earlier this month.
In case of the other GlaxoSmithkline drug, cefuroxime axetil, Ranbaxy had an added advantage being the only generic maker to have been granted approval.
In May last year, a US district court judge had invalidated GlaxoSmithkline's three patents on the drug. The patents expired in December 2002.
The originator also filed a lawsuit against Ranbaxy, Teva and Geneva in August 2002, alleging the three had used stolen bacteria from GlaxoSmithkline to make copies of Augmentin.
GlaxoSmithkline later filed a similar lawsuit against Lek Pharmaceuticals, too, alleging that the company was using confidential information from GSK to produce generic versions of the drug.
The launch of generic versions of Augmentin is likely to effect GlaxoSmithkline's profits tremendously as it was the company's second largest selling drug, behind the anti-depressant Paxil. GlaxoSmithkline's had been selling Augmentin in the US since 1984.
Amoxicillin/clavulanate potassium tablets are indicated in the treatment of infections caused by susceptible strains of the designated organisms in conditions like lower respiratory tract infections, otitis media, sinusitis, skin and skin structure infections and urinary tract infections.