Pharmaceutical Resources, Inc. (PRI) has entered into a broad-based co-marketing and development agreement with Dr. Reddy’s Laboratories (Reddy).The agreement covers fourteen drugs to be marketed through PRI’s primary operating subsidiary, Par Pharmaceutical, Inc., (Par). Abbreviated new drug applications for six of the drugs have been filed with the FDA and are pending approval.
Through PRI’s strategic alliances and its own development program, the Company now has 23 ANDAs with the FDA awaiting approval.Included in this group of products is fluoxetine 40mg capsules, which Reddy was first -to-file and Par anticipates receiving up to 180 days exclusivity.
Fluoxetine, the generic version of Eli Lilly and Company’s Prozac, is indicated for the treatment of depression.
Sales of the 40mg brand capsules were approximately $125 million over the past twelve months.
PRI will now be the only company to market all strengths of fluoxetine during the exclusivity period.
PRI anticipates marketing all three strengths starting on August 2, 2001.
Reddy is one of India’s largest pharmaceutical companies and currently has a market capitalization in India of approximately $800 million U.S. It is a vertically integrated producer of bulk active ingredients for the pharmaceutical industry and a developer and manufacturer of finished dosage forms.
Reddy is also developing several unique branded pharmaceutical products.
PRI, a holding company, develops, manufactures, and distributes generic pharmaceutical products through its wholly owned subsidiary, Par.