Replies to post #13796 on Intellipharmaceutics International Inc. (IPCI)

[hondobud]

Looks like 6 Focalin patents expired on Dec 4, 2015.

The reference listed drug (RLD) upon which you have based your ANDA is Focalin XR Extended-release Capsules, 25 mg, 30 mg, 35 mg and 40 mg, of Novartis Pharmaceuticals Corp. (Novartis). This RLD is subject to periods of patent protection. The following patents and their expiration dates are currently listed in the agency’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) for this drug product:
Reference ID: 3409525
U.S. Patent Number Expiration Date
5,837,284 (the '7284 patent) Dec 4, 2015
5,908,850 (the '850 patent) Dec 4, 2015
6,228,398 (the '398 patent) Nov 1, 2019
6,355,656 (the '656 patent) Dec 4, 2015
6,528,530 (the '530 patent) Dec 4, 2015
6,635,284 (the '5284 patent) Dec 4, 2015
6,730,325 (the '325 patent) Nov 1, 2019
7,431,944 (the '944 patent) Dec 4, 2015

So may be an approval letter coming for us soon. I assume the FDA will now be revewing their applications regarding Focalin.