Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Isn’t our antimetabolite a small $42M market generic?

I previously speculated our antimetabolite might be Siklos (hydroxyurea tablets), which loses pediatric exclusivity Dec 2024. I do not know the annual sales of Siklos, so I cannot confirm, just a guess. I think it is worth reiterating that Siklos was approved with priority review, orphan drug status, and pediatric exclusivity, so it costs around $1900 per month. At the same time, the exact same medicine in capsule form costs $20 per month. Until last year, Siklos was officially FDA-approved only for pediatric sickle cell disease, while hydroxyurea capsules have multiple additional indications (see my previous post). One might surmise why it was not a huge commercial success, but that doesn’t mean there is no market. If generic hydroxyurea tablets are cost-competitive with generic capsules, then they will immediately compete in a much larger market as the standard of care medication for both adult and pediatric sickle cell disease. As I said in the previous post, I believe an easy-dispersing, cost-competitive tablet could become the dominant form not just for SCD but also for all the other indications for hydroxyurea as well. I would also mention the U.S. market is a small portion of the world SCD market.

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one should take caution when considering the annual sales of brand name Siklos. First, Siklos is only FDA-approved for pediatric and adult SCD, not all the other stuff. Second, Siklos tablets costs literally 100X generic hydroxyurea capsules, with only minimal advantage. If cost-competitive, a generic tablet would immediately compete with all of the generic capsules for every hydroxyurea indication, not just SCD. I believe a generic dissolving tablet could potentially become the dominant form, but cost will always beat convenience at the pharmacy, so pricing will determine its acceptance and use. The first company to file an ANDA application for generic Siklos will receive six months of generic exclusivity for the tablet form.

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