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Intellipharmaceutics Announces Launch of Generic Seroquel XR® by Mallinckrodt
Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:IPCI) (“Intellipharmaceutics” or the “Company”), a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs today announced that Mallinckrodt LLC (“Mallinckrodt”), in its capacity as the Company’s marketing and distribution partner, launched all strengths of the Company’s generic Seroquel XR® (quetiapine fumarate extended-release tablets) in the U.S. This launch follows the recent final approval from the U.S. Food and Drug Administration (“FDA”) for the Company’s abbreviated new drug application (“ANDA”) for quetiapine fumarate extended-release tablets in the 50, 150, 200, 300 and 400 mg strengths.
Dr. Isa Odidi, CEO and co-founder of Intellipharmaceutics, stated, “We are pleased to share the news of our generic Seroquel XR® launch by our valued partner Mallinckrodt. This is our second ANDA to be commercialized in the U.S. and follows the recent launches of 4 additional strengths of generic Focalin XR® by Par Pharmaceutical, Inc. The launch of generic Seroquel XR® should enhance the significant revenue improvement we have realized thus far in 2017.”
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 April 2017 of the 50, 150, 200, 300 and 400 mg strengths of Seroquel XR® (branded and generic) were approximately U.S. $842 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.
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