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lasers

02/10/16 3:43 PM

#183378 RE: NASDAQ2020 #183373

Pfizer's ALO-02 NDA Oxy/Nal would have a 3 to 5 yr exclusivity, so that a Generic would not be applicable until the exclusivity period expires.

However Pfizer's ALO-01 Mor/Nal exclusivity has expired and is wide open for a Pharmacological generic.

Jimmy Joe

02/11/16 1:38 PM

#183627 RE: NASDAQ2020 #183373

NASDAQ thanks for mentioning that. In the meantime Elite can possibly use a two bead approach... no?

TIA

lasers

02/11/16 1:54 PM

#183630 RE: NASDAQ2020 #183373

Pfizer ALO-02 Oxy/Nal has not been approved therefore $ELTP cannot make a generic to submit to the FDA approval.

However Pfizer Mor/Nal has been approved since 2009 as 505B2 with a 3 to 5 year exclusivity which has since expired. Therefor $ELTP can submit a Mor/Nal generic pharmacological