Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Excellent information...

Lisdex is the API for Vyvanse®, the leading branded pharmaceutical product for the treatment of attention deficit hyperactivity disorder (ADHD), with FY 2019 annual sales surpassing $2.5 billion (now ~ $3.7B). Patient demand for the generic version is expected to be strong after the patent expires.

For Elite, this has to be THE top shelf development effort. Nasrat has lamented that the FDA delay on Adderall approval put them behind the curve in its market intrusion, as others were able to jump into competition sooner. Without question, Nasrat is aware of the Vyvanse development opportunity based on his position and experience. Still, as a means to create expectations, I leave nothing to chance when letting him know investors are aware...

The following was included in an email I sent to him December 11, 2021...

Although I mentioned this to Dianne in one of my more recent pre-CC questions/observations, a generic Vyvanse has to be one of the drugs on the list Elite is developing, as it will be coming off patent in 2023 and fits the two-year window you have discussed. Not lost on the learned, you well know it has a global market greater than Adderall and Concerta combined and by a factor of more than 2X.

Still, Elite will not be the only company seeking to enter the generic market for Vyvanse. Others are already set to compete. Having lost in court to overturn the patent, the following companies have submitted ANDAs with the FDA for a generic version of Vyvanse and are likely waiting for 2023 patent expiration:
• Amneal Pharmaceuticals
• Roxane Laboratories
• Sandoz, a subsidiary of Novartis
• Mylan Pharmaceuticals
• Actavis, which is now part of ABBVIE