Intellipharmaceutics International Inc. (IPCI)

[AngeloFoca]

Handa believes it is the first applicant to file an ANDA containing a paragraph IV certification for the 50 mg, 150 mg, 200 mg and 300 mg strengths of the product, which would potentially provide 180 days of marketing exclusivity. According to IMS Health data, annual U.S. sales for these strengths of Seroquel XR® are approximately $808 million. The ANDA also includes a 400 mg dosage strength.

The way they've broken off the 400 mg dosage definetely says Handa does not have first filer rights on that dosage.

I definetely remember the previous CFO say during a presentation where he was going down the list of generics one by one - "I believe we were first filer on one strengths". re: Seroquel XR.

So I assume we will get Approval on the 400mg and tentative approval on other strengths by november 2016