Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

...filed an Abbreviated New Drug Application (ANDA) on August 17, 2023

My 2 cents is that this seems kind of weird to be our generic OxyContin ANDA. Mainly because Elite vey publicly filed an ANDA for generic OxyContin in September 2017, so why file an entirely new application in August 2023? Maybe they developed a new molecule and scrapped the old one since the 2017 application, but I don't recall hearing about new bioequivalence studies on any new opiate molecules. Likewise, I don't recall hearing that the 2017 OxyContin application was dead with the FDA.

The wording of today's PR seems so cagey and nonspecific:

an undisclosed generic drug product in a class of medications called opiate analgesics. IQVIA reported annual sales for the twelve months ending June 2023 of $720 million for the brand and generic market for this product.

In contrast, here's what they said in 2017:

filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for a generic version of OxyContin® (extended release Oxycodone Hydrochloride). OxyContin® is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. OxyContin® is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin® and its equivalents in 2016.

"I am very pleased with this filing of an ANDA for a generic version of OxyContin®. This is our fourth ANDA filing in the past 15 months and is a key addition to our portfolio," said Nasrat Hakim, President and CEO of Elite.

I'm just thinking out loud, but it made me say, "Huh." There really aren't many opiates in that ballpark of annual sales, so it most likely is a new application for generic OxyContin for some unknown reason. However, it occurs to me today's PR would also fit just fine with a refiling of generic Norco (hydrocodone/acetaminophen). The $700 million range is about right for brand name and generics (99% generics), and our bioequivalence studies were all done back in 2015-2016, so NO new bioequivalence would be required or reported by PR. Basically, send in the exact same application for generic Norco that was previously approved in 2018. It's a remote possibility, I know, but nothing in today's PR excludes a refiling of generic Norco. Just sayin'.

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