Elite Pharmaceuticals Inc (ELTP): “We filed two other ANDAs earlier this y...

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Re: YJ4LIFE post# 303638

Wednesday, 11/14/2018 10:10:08 PM

Wednesday, November 14, 2018 10:10:08 PM

“We filed two other ANDAs earlier this year. One is the ANDA of an immediate release CNS product that we co-developed with our partner SunGen, for which there is a brand and generic sales of approximately $400 million.

Elite is hopeful that this product will be approved in December of this year. That is our PDUFA date. We will wait to hear from FDA. The second ANDA is an extended release CNS product that we co-developed with our partner SunGen. The brand and generic sales of that product, the extended release version is $1.6 billion.

There are currently four manufacturers including the brand and the authorized generic. We are expecting approval and launch in Q2 of 2018.”

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