PTE process

[figglebird]

anyone with knowledge or thoughts on how PTE's are determined talk about the process with respect to something like TS, as in TS TYVASSO? Would the fact that TS Insulin(Afrezza) having been approved, all but necessitate extension of patent for uthr's PAH trepostinal med? 

In researching dpi competitors to try and gain insight into what I have gathered may be a somewhat new horizon on patent extension(DPI's) in general - A adamis was approved for an epi generic(non DPI), their valuation diminished, prob bc generic... or whatever. 

tx

[matt]

If the combination of a drug and a different delivery system are sufficiently novel, then it may be granted a patent. The patent term on the underlying drug will still expire as scheduled, but if the combination product is more useful than the drug alone this may not matter.

Many pharma companies in the 1990's invented new drugs for metabolic disease that required three-a-day dosing. Along comes Alza (a drug delivery company now part of J&J) with their "XR" extended release technology. Suddenly a lot of drugs that were due to go off patent appeared with an XR version that required once-a-day dosing. The trick to making this work is a full court press by the sales force to get physicians to stop prescribing the three-a-day formulation and start prescribing the XR formulation well before the original drug went off patent and generics enter the market. Generally a switching period of about 24 months was needed. In a few cases the original formulations were withdrawn from the market or otherwise made very difficult to obtain, and a generic drug with different dosing requirements is treated as a different drug. Since most generic firms have almost no sales force, a proper roll-out of a new formulation is equivalent to keeping the generic out of the market. Insurance went along with this because patients are much more compliant with once-a-day medications.

So, would a TS formulation of Tyvasso eligible for patent protection? Almost certainly yes. Are the benefits to the patient so compelling as to justify switching the entire market to the new formulation? That remains to be seen. Insurance companies have gotten wise to the reformulation trick so it comes down to an evaluation of how much the new formulation costs versus the old formulation compared with the differential benefits to the patients. Some drugs can pass that test, some cannot. This will be another case where the benefits have to be substantiated such that the label copy approved by FDA reflects the greater benefit. Absent the right label copy, it will be deja vu all over again.

[figglebird]

Got it, thank you - helpful - would it also be accurate to say that with respect to pte's generally speaking - a DPI offers a relatively new take on the trick(xr etc) aka novel - as far as you know besides nktr is ts tge first novel dpi in this arena potentially - and with that

[agedhippie]

Oct 9, 2018 7:21:09 GMT -5 matt said:

...
So, would a TS formulation of Tyvasso eligible for patent protection? Almost certainly yes. Are the benefits to the patient so compelling as to justify switching the entire market to the new formulation? That remains to be seen. Insurance companies have gotten wise to the reformulation trick so it comes down to an evaluation of how much the new formulation costs versus the old formulation compared with the differential benefits to the patients. Some drugs can pass that test, some cannot. This will be another case where the benefits have to be substantiated such that the label copy approved by FDA reflects the greater benefit. Absent the right label copy, it will be deja vu all over again.

This is what Novo Nordisk has done with Fiasp pricing Fiasp the same as Novolog which is now partially off patent. The doctors move patients from Novolog to Fiasp since it gives (marginally) better results, and the insurers are don't care because the cost remains flat. Meanwhile Novo Nordisk retain their market share.