BLOG: Update on generic Restasis and ‘Fauxstasis’
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Have you had anybody who is actually taking a “generic Restasis”? No? Me either.
We’ve certainly gotten all kinds of written notice from insurance companies and pharmacy benefit managers that there is some kind of generic out there, but as of yet, no one in our practice has filled a prescription. Why an update? It turns out that there is a ton more to this story than we’ve all been led to believe.
It turns out that there are actually two real Restasis generics!
So, does that mean I was wrong about the 0.05% cyclosporine A in a lipid emulsion made by Mylan that I have named “Fauxstasis”? Nope. I am spot on correct in every way. Fauxstasis is presently on the market and priced at $480 for a 1-month supply (not a typo; roughly 92% of the Restasis list price). However, as I noted, the lipid emulsion in which that 0.05% cyclosporine A is floating is not Endura, the vehicle in Restasis (Allergan). It is up to Mylan to prove that it works like Restasis and has a similar side effect profile. Until we get some real-world experience of the Mylan product in the wild, it is still Fauxstasis.
Ready for the Paul Harvey moment? Ever heard the term “authorized generic” (AG)? I always thought that AG meant a generic version of a drug in which the original formula is licensed to a generic company that then goes on to manufacture the product. At the moment, there are two AGs in the U.S. market selling a true generic Restasis. Apotex is a small generic company getting the lion’s share of scripts, with the large Canadian company KKV also entering the fray. How do I know that Apotex and KKV are selling a real, live, honest-to-goodness generic Restasis?
Because the stuff they are selling is being made by Allergan!
It turns out that AG can also mean manufactured by the original company and then sold under contract by the generic company. A careful look at the Apotex package reveals a little label in teeny tiny print: “Manufactured by Allergan Sales LLC.” Kind of like a “house brand,” if you will. You don’t really think Costco actually makes Kirkland Champagne, do you? Someone else makes it, they slap a “manufactured in” label on the back of the bottle and sell it as a Costco product. Similar stuff here. While I haven’t seen a KKV package, I think it’s safe to say that the same situation exists. This means that we do, indeed, have two true Restasis generics entering the market, apparently retail priced around 60% of Restasis. This is big.
More to come.
*I have not spoken with anyone at any of the companies named, either on or off the record. All information noted is publicly available.
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