Mumbai, March 11: Dr Reddy’s Laboratories (DRL) today announced that the company has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for the generic version of Eli Lilly’s schizophrenia drug.
The application is for Olanzapine Orally Disintegrating Tablets (ODT), equivalent to 5mg, 10mg, 15mg and 20mg. Dr Red’s added that it 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.
The Hyderabad-based company, however, believes it has the first-to-file status on all dosage strengths and if successful in its litigation, would enjoy a 180-day marketing exclusivity.
DRL also stated that drug delivery system for the Olanzapine ODT ANDA was developed in-house. Olanzapine ODT is the generic version of Eli Lilly’s Zyprexa Zydis and is prescribed for the management of the “manifestation of psychotic disorders”. The brand has annual sales of around $ 106 million in the US.