Ranbaxy Laboratories Limited (RLL) has received tentative approval from the U.S. Food and Drug Administration to manufacture and market Ofloxacin Tablets 200 mg, 300 mg, and 400 mg. In 2002, sales for Ofloxacin Tablets totaled $ 31.3 Million (IMS - MAT, April 2003). The product is one of the first oral quinolones experiencing patent expiration having the most extensive clinical record of safety and efficacy in the quinolone class of antibiotics.
Ofloxacin Tablets (Floxin) are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms for infections such as acute bacterial exacerbations of chronic bronchitis, community-acquired Pneumonia, uncomplicated skin and skin structure infections, acute, uncomplicated urethral and cervical gonorrhea, nongonococcal urethritis and cervicitis, mixed infections of the urethra and cervix, acute pelvic inflammatory disease, uncomplicated cystitis, complicated urinary tract infections and prostatitis.
According to a company press release, the product is expected to be available through wholesalers and other distribution outlets to dispensing pharmacies throughout the United States at the time of patent expiration. Product will be marketed by the Sales Team of Ranbaxy Pharmaceuticals Inc (RPI), as a generic alternative to the branded product.
According to Dipak Chattaraj, President of RPI, USA, "The approval of Ofloxacin Tablets is yet another addition to the RPI product portfolio of anti-infectives. This product, with a well-established record of efficacy and safety in a variety of clinical indications, should find a niche in a number of market segments, including: managed care, private health plans, and governmental programs. We are delighted to offer this product as an affordable generic formulation to the branded product."
Based in Princeton, New Jersey, RPI is a wholly owned subsidiary of RLL, India, having established operations in the U.S. in 1994 and launching its first prescription product in January 1998, following FDA approval in August 1997.
For the year 2002, U.S. operations achieved sales of U.S. $ 296 mn, a growth of 162% over the corresponding year. During 2002, RPI filed 23 ANDAs (surpassing its target of 15-20 ANDA filings annually) and received 11 approvals. Currently the cumulative number of approvals is at 66. RPI markets a basket of generic products covering major therapeutic areas. In 2002, RPI was ranked as the 9th largest in the U.S. generics market.