DRL launches Prozac generic version in US

Our Corporate Bureau

Hyderabad, Aug 3: DR Reddy’s Laboratories (DRL) has launched fluoxetine 40 mg, the generic version of the pharma major Eli Lilly’s $250-million brand Prozac, in the US generic market on Friday. The product was launched in association with an alliance partner Pharmaceutical Resources Inc.

With this launch, DRL has become the first Indian company to launch a generic product with a 180-day marketing exclusivity in the US generics market, the company claimed.

The company has received the final US FDA approval to market its fluoxetine 40 mg capsules on August 2.

During the market exclusivity period, DRL and the US partner would be the only entrant to the market with the entire range of dosage strengths (10 mg tablets, 20 mg tablets and 40 mg capsules).

On July 27, a final judgment was issued by the District Court for the district of Indiana and the case against Dr Reddy’s was dismissed. DRL, which received the 180-day marketing exclusivity for fluoxetine 40 mg capsules effective July 27, 2001, could not launch the product until the expiration of the 6-month pediatric exclusivity of Eli Lilly’s Prozac.

DRL has been very active in filing Paragraph IV Certifications and believes it first has to file status on omeprazole 40 mg capsules (Astra Zenica’s Prilosec), ciprofloxacin 100 mg and 750 mg (rolling exclusitivity) tablets and olanzapine 20 mg tablets.

The company has already obtained US FDA approvals for ranitidine (150, 300 and 75 mg) capsules, famotidine (20 and 40 mg) tablets, oxaprozin (600 mg) tablets.