Intellipharmaceutics International, a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs, has received final approval from the US Food and Drug Administration (FDA) for the company's abbreviated new drug application (AND) for quetiapine fumarate extended-release tablets in the 50, 150, 200, 300 and 400 mg strengths. This approval follows the expiry of 180-day exclusivity periods granted to the first filers of generic equivalents to the branded product, as previously disclosed by the company. The approved product is a generic equivalent of the branded product Seroquel XR sold in the US by AstraZeneca Pharmaceuticals LP.

The company previously announced that it had entered into a license and commercial supply agreement with Mallinckrodt LLC (Mallinckrodt), granting Mallinckrodt a license to market, sell and distribute in the US the company's quetiapine fumarate extended-release tablets (generic Seroquel XR).  Under that agreement, the company manufactures and supplies the licensed product for Mallinckrodt.  The company has manufactured commercial quantities of all strengths of generic Seroquel XR, and expects to ship product to Mallinckrodt imminently under its commercialization agreement. That agreement also includes two other product candidates, our generic Pristiq and generic Lamictal XR, for which the Company has ANDAs under FDA review.

Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics, stated, "We are thrilled that the FDA has granted final approval for our generic Seroquel XR, and that we have successfully manufactured commercial quantities of all strengths.  We have now demonstrated that our core drug development competency in controlled-release delivery technologies is complemented by our commercial drug manufacturing capability.  We are pleased to have Mallinckrodt as our U.S. commercial partner and believe that generic Seroquel XR represents a substantial commercial opportunity for Intellipharmaceutics."

Seroquel XR, and the drug active quetiapine fumarate, are indicated for use in the treatment of schizophrenia and bipolar disorder. According to Symphony Health Solutions, sales in the United States for the 12 months ended March 2017 of the 50, 150, 200, 300 and 400 mg strengths of Seroquel XR (branded and generic) were approximately US $908 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer's published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). There can be no assurance that the Company's generic Seroquel XR in any of the 50, 150, 200, 300 and 400 mg strengths will be successfully commercialized.