Intellipharmaceutics Settles Patent Litigation With AstraZeneca Concerning Generic Seroquel XR(R)
TORONTO, Jul 31, 2012 (GlobeNewswire via COMTEX) -- Intellipharmaceutics International Inc. IPCI -1.43% CA:I -3.74% , 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 it had reached an agreement with AstraZeneca to settle all outstanding patent litigation concerning its abbreviated new drug application ("ANDA") for the commercialization in the United States of a generic version of the AstraZeneca drug product, Seroquel XR(R) (quetiapine fumarate extended-release) tablets.
On July 30, 2012, and pursuant to the settlement, AstraZeneca and the Company filed proposed Consent Judgments in the District Court for the Southern District of New York to conclude the litigation, subject to other regulatory review. The settlement provides, in part, that the Company is permitted to launch its generic versions of the 50, 150, 200, 300 and 400mg strengths of Seroquel XR(R), on November 1, 2016, or earlier in certain circumstances, subject only to prior U.S. Food and Drug Administration ("FDA") approval of the Company's ANDA for those strengths. All other terms of the settlement are confidential. The Company's actual launch may also be subject to a six month statutory delay relating to a prior filer of a generic equivalent of the branded product.
Dr. Isa Odidi, CEO and co-Chief Scientific Officer of the Company stated, "We are pleased to conclude the litigation with AstraZeneca on these terms. The agreement permits us to bring our generic Seroquel XR(R) product to the market in advance of the expiry of the AstraZeneca patents in November 2017, and removes the ongoing expense and uncertainty inherent in patent litigation."
Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The Company's patented Hypermatrix(TM) technology is a multidimensional controlled-release drug delivery platform that can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of product candidates in various stages of development, including six ANDAs under review by the FDA, in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes, pain and infection.
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SOURCE: Intellipharmaceutics International Inc.