Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

A generic of the current version of OxyContin is overdue. Elite might be among the first to market… we will see.

Agreed, well overdue. I think of Lyrica (pregabalin) as a likely example. In 2019, FDA gave more than a dozen generic approvals nearly simultaneously. The year before, in 2018, Pfizer recorded $3.6B in sales of the brand name. They lost 1/3 of their market share in the single month of July 2019. By 2021, total sales of pregabalin were down to $770M and divided among ~20 competitors. What that looked like from a physician perspective was impressive. Literally overnight the drug went from $500/month to $50/month. Every few weeks it dropped another $10 until it reached what it is today, about $20 for a 90 day supply without insurance. Even though total annual sales decreased precipitously, the number of people able to afford the drug went up with the same steep slope, so the number of pregabalin prescriptions went way up. As that happened, the number of OxyContin scripts went way down, and it was not a coincidence. The trend represents a significant national shift in strategy for chronic pain management. Now, total sales of OxyContin are well below a billion dollars without a single generic competitor. I expect the FDA will proceed more cautiously with generic OxyContin, but I anticipate we will see a dozen or so competitors in fairly rapid fashion. If so, with pregabalin as our model, then look for annual sales of generic OxyContin to top out in the ~$250M range divided by a ~dozen competitors within about ~2 years.

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