Replies to post #23704 on Intellipharmaceutics International Inc. (IPCI)

[wimuskyfisherman]

Angelo- I do not think it is out if the question for Focalin sales to hit $8M for IPCI in 2017. I also think that when PAR gets all doses on the market, and there is competition in all doses, we can still expect over $4M of revenue annually for Focalin sales.

[Samsa]

Angelo.....good point. just who else out there, if anyone, has an application on these doses?

[Amigo Mike]

Angelo,

Good thought.
As as I can tell, PAR is the only pharma to have received approval on the 25 and 35mg doses. 8 doses in total.

IMPAX has approval for 4 doses. No 25/35 mg doses
Mylan and Teva have approval for 6 doses. No 25/35 mg doses.

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202842Orig1s000ltr.pdf

It would appear though that Teva has "tentative approval" for the 25 and 35mg doses as noted here and would presumably receive final approval when the exclusivity period is over:
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202731Orig1s000ltr.pdf

Would appear IMPAX has it on their most recent report as pending as well.

Amigo Mike