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Intellipharmaceutics Announces Launch of Generic Seroquel XR

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Intellipharmaceutics International Inc.IPCI announced the launch of a generic version of schizophrenia drug, Seroquel XR by its marketing and distribution partner in the U.S, Mallinckrodt Public Limited Company MNK .

The launch was preceded by FDA approval of the company's abbreviated new drug application (ANDA) in May 2017.

Astrazeneca plc's AZN Seroquel XR is indicated for use in the treatment of schizophrenia and bipolar disorder.

The drug was launched as extended-release tablets for all strengths including 50, 150, 200, 300 and 400 mg. Total sales in the U.S. for Seroquel XR, in both branded and generic version, was $842 million for the 12 months ended Apr 2017. We believe that the launch in the U.S. will further boost the performance of Intellipharmaceutics' generics business.

IntelliPharmaCeutics' shares gained 8.16% following the announcement. However, the stock has underperformed the Zacks classified Medical - Drugs industry so far this year. The company's shares lost 25.4%, while the industry registered an increase of 4.9%.

In Oct 2016, Intellipharmaceutics entered into a license and commercial supply agreement with Mallinckrodt, granting the latter an exclusive license to market, sell and distribute generic Seroquel XR, Pristiq and Lamictal XR in the U.S., for which it had filed abbreviated new drug applications (NDAs). The generic versions of Pristiq and Lamictal are currently under review.

Meanwhile, the generic version of Seroquel XR is already marketed by some major pharma companies like Endo International PLC ENDP , India-based Lupin Ltd., as well as by some smaller companies. Hence, Intellipharmaceutics will face tough competition as far as its commercialization is concerned.

Moreover, in May 2017, Intellipharmaceutics had announced that its partner Par Pharmaceutical launched 10 and 20 mg strengths of its marketed generic version of Focalin XR capsules. The generic version was available in 15, 25, 30 and 35 mg strengths prior to the launch.

Intellipharmaceutics specializes in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. The company has also filed NDA 505(b)(2) for its specialty drug product candidates in development including Rexista, an abuse-deterrent oxycodone product and Regabatin XR, a neuropathic pain management product.

Intellipharmaceutics International Inc. Price

Intellipharmaceutics International Inc. Price | Intellipharmaceutics International Inc. Quote

Zacks Rank

IntelliPharmaCeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here .

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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