IntelliPharmaCeutics International Inc. (USA)(NASDAQ:IPCI) has obtained a tentative consent from the U.S. FDA for its abbreviated new drug application for quetiapine fumarate tablets in the 400, 300, 50, 150, 200 and 300 mg strengths. The firm’s tentatively-approved drug is a generic equivalent for the matching strengths of the product Seroquel XR® available in the U.S. by AstraZeneca plc (ADR)(NYSE:AZN).
Pursuant to a settlement deal between AstraZeneca and IntelliPharmaCeutics dated July 30, 2012, the firm is allowed to introduce its generic versions of the 400, 300, 50, 150, 200 and 300 mg strengths of generic Seroquel XR®. It is planned to be done in November 2016, depending to FDA final consent of the firm’s ANDA for respective strengths.
Such FDA closing consent is subject to a 180-day exceptionality period connecting to a prior filer of a generic equivalent of the product. Two firms have first-to-file designation and may be in a place to launch in November 2016. The intent is to introduce these strengths after FDA approval following end of the other firms’ exclusivity period.
There are presently no substitutes of Seroquel XR® available in the United States market as the drug is still under AstraZeneca’s patent zone until November 2017. There can be no guarantee that the firm’s quetiapine fumarate tablets in any of the 400, 300, 50, 150 and 200 mg strengths will obtain final FDA consent, or if permitted, that they will be effectively commercialized.
The management view
Dr. Isa Odidi, the co-founder and CEO of Intellipharmaceutics, said that they are excited the FDA has given tentative nod of generic type of Seroquel XR®. It should further show core drug advancement competency in controlled-release distribution technologies. As drug Seroquel XR® has still to move out of patent protection, they consider the tentative approval signifies a considerable commercial opportunity for the firm.
Seroquel XR®, and the medicine active quetiapine fumarate, are specified for use in the cure of bipolar disorder and schizophrenia. As per Symphony Health Solutions, revenue in the U.S. for the one-year completed August 2016 of the 400, 300, 50, 150 and 200 mg strengths of Seroquel XR® came around $1.2 billion.