Dr. Reddy's Laboratories (DRL) has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Olanzapine Orally Disintegrating Tablets (ODT), equivalent to 5mg, 10mg, 15mg and 20mg. The ANDA is in reference to Paragraph IV certification on the 5, 229, 382 patents, the company sources informed.

DRL has also notified Eli Lilly, upon which the latter filed a lawsuit against the company in the United States District Court for the Southern District of Indiana, alleging patent infringement on the '382 patent. Dr. Reddy's believes that it has the first-to-file status on all dosage strengths and if successful in its litigation, would enjoy a 180-day marketing exclusivity.

The Company also stated that drug delivery system for the Olanzapine ODT ANDA was developed in-house. Olanzapine ODT is Eli Lilly's Zyprexa Zydis and is indicated for the management of the manifestation of psychotic disorders. According to IMS 2002 report, the brand has annual sales in the United States of approximately $106 million.