The Hindu Business Line : Ranbaxy, Reddy's get final USFDA approval for Ciprofloxacin

RANBAXY Laboratories Ltd and Dr Reddy's Laboratories Ltd have received final approval from the US Food and Drug Administration (USFDA), for the manufacture of Ciprofloxacin tablets.

A statement from Ranbaxy said the company had receive approval to manufacture and market Ciprofloxacin tablets in 250 mg, 500 mg and 750 mg used to treat infections.

The total sales for Ciprofloxacin are about $1.4 billion, with sales of the immediate release tablet accounting for a total of $1 billion. In a company statement, Mr James Meehan, Vice-President, Sales and Marketing, Ranbaxy Pharmaceuticals Inc, said, "We will begin shipping the widely prescribed anti-infective immediately and will be able to provide the product to our customers as of today. Subsequently, it is anticipated that this affordable generic alternative will have a positive impact that will benefit the US healthcare system, patients and prescribers."

Dr Reddy' s said it had obtained the final approval for the company's abbreviated new drug application (ANDA) for Ciprofloxacin tablets 100 mg, 250 mg, 500 mg and 750 mg.

In a release here on Thursday, the company said it is eligible for 180-days of market exclusivity for the 100 mg strength.

Ciprofloxacin is the AB-rated generic equivalent of Bayer Corporation's drug `Cipro.' It is a broad-spectrum antibiotic, approved for the treatment of several types of infection. As per IMS 2003, the product had annual US brand sales of approximately $1 billion.

Dr Reddy's plans to shortly launch Ciprofloxacin in 100mg strength on its own directly into the US market, which makes it the third generic product under its own label.

During the fiscal year 2003-04, Dr Reddy's filed 13 ANDAs, including eight Para-IV applications before the USFDA.

At present, the company's generic product pipeline includes 35 ANDAs pending approval with the USFDA. Of these, 24 are Para-IV filings targeting innovator sales of $21 billion as per IMS September 2003 MAT. Dr Reddy's believes it has first to file status on 12 of the 24 Para-IV filings.

Some of Dr Reddy's patent challenges are now maturing and the company expects that they could bring its major opportunities over the next few years, depending on the favourable Court decisions. These patent challenges include the generic equivalents of Eli Lilly's Zyprexa, Pfizer's Zofran, Novartis' Lamisil, Sanofi's Clopidogrel and Pfizer's Zoloft.