![](https://investorshub.advfn.com/uicon/477123.png?cb=1533675489)
Wednesday, March 16, 2016 6:10:01 PM
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
Recent IPCI News
- Suspension de la négociation par l'Organisme canadien de réglementation des investissements - IPCI • PR Newswire (Canada) • 03/06/2024 12:55:00 PM
- Canadian Investment Regulatory Organization Trading Halt - IPCI • PR Newswire (Canada) • 03/06/2024 12:51:00 PM
FEATURED Element79 Gold Corp Announces 2024 Clover Work Plans & Nevada Portfolio Updates • Sep 10, 2024 11:00 AM
Nightfood Holdings Inc. Completes Major Step on Uplist Journey by Closing Strategic All-Stock Acquisition of CarryoutSupplies.com • NGTF • Sep 10, 2024 8:15 AM
Element79 Gold Corp. Announces Sale of 100% Interest in Elder Creek, North Mill Creek, and Elephant Projects to 1472886 B.C. Ltd. • ELEM • Sep 9, 2024 9:34 AM
North Bay Resources Commences Gold Shipments, Fran Gold Project, British Columbia; Enters Taber Gold Mine JV, Sierra County, California • NBRI • Sep 9, 2024 9:15 AM
Simple Stock Loans Announces Unique Solutions For Investors Looking for Alternative Liquidity Amidst Recent Small Cap Rally Sep 6, 2024 9:30 AM
Reliant Coffee Debuts at #271 on the Inc. 5000 List of Fastest Growing Companies - Coffee Service Industry Disruptor Brews Up Exponential Growth Sep 5, 2024 11:51 AM