The Anthrax scare is spreading like fire in the US. Ciprofloxacin is the only antibiotic specifically approved by the FDA to treat anthrax infections, although other antibiotics are believed to be as effective. The demand for Ciprofloxacin has thus shot through the roof in the US. The US health administration has issued a directive to stock up Ciprofloxacin.
Ciprofloxacin is a patented drug of Bayer, which sells under the brand name Cipro and is widely used for bladder, urinary and respiratory infections. It is Bayer's best-selling drug, with annual sales (prior to the anthrax scare) of US$ 1 bn in the US and US$ 1.6 bn globally, selling in over 100 countries around the globe.
There are atleast a couple of dozen Indian pharma firms, which manufacture generic version of Ciprofloxacin including Dr. Reddy’s, Ranbaxy, Cipla, Cadila etc. However, Indian firms are losing out on this opportunity as the drug is currently patented and thus none of them can sell this formulation or bulk in the US.
Just to recall, Ranbaxy has infact licensed out its new drug delivery system (NDDS) form of Ciprofloxacin (Cipro-D) to Bayer. The product is in the last stage of clinical trials (Phase-III) before which the drug could be sold in the market. However, it is expected that Bayer would put Cipro-D out only in the end of 2002.
Indian firms are thus losing out on this big generic opportunity because of the patent issue. They are just hoping that the US FDA might grant compulsory license to generic firms in view of this special circumstance. Cipla has infact issued a statement to this effect, offering to sell generic version of the product in the US market. However, this seems a far-fetched possibility. Bayer AG has already indicated to increase its production of Ciprofloxacin by roughly 25% to treat anthrax infections.
What could probably happen in case the drug requirement increases beyond proportion for Bayer to handle, then it might outsource it from Indian players and share a small pie of the cake. Only thing Indian pharma firms can do for now is to keep their fingers crossed.
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