[DarkStar851]

Yes, the old drug patent will expire, and when this happens the company typically pulls an "oh our old version is now magically unsafe!" to wrestle away competition.

Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.

[hjk05]

Do you have references for that claim? If a company goes out with a claim their old product is unsafe it’s not like it’s rocket science to test the claim. And if their lying and you could literally corner a billion dollar industry by testing the claim I’d expect every producer of generics to do so. On the other hand if the product is actually unsafe that opens up liability claims from costumers.

[Scoundreller]

I've seen companies create "extended release" formulations of their old formulation 1 year before the patent expires to get everyone to switch over to the patented version before the generic comes out.

I've even seen it done when the previous version and the new version were still both once daily (tamsulosin, I'm looking at you!)

Yes, some insurers will hesitate to cover the new formulation when it comes out, but not all.

Sometimes the insurer will make a deal with the manufacturer so that the manufacturer is only getting paid the generic-equivalent price. But who knows what happens behind closed doors.

[hjk05]

Changing the release profile of a drug from once daily to once weekly isn’t a minor thing, and no one is forcing customers to pick the once weekly over the once daily. Now with respect to the original claim, are you saying that once there was a new version of tamsulosin the company issued a statement claiming the old version was unsafe? Do you have a reference for that?

[Scoundreller]

1. The consumers aren’t really choosing, their prescribers are, with a lot of friction required to change against their initial decision.

2. While they still had the patent on the regular tamsulosin formulation, they stopped making it. Effectively forcing everyone onto the XR formulation unless they wanted to change molecules entirely.

The data showed little difference as I recall in terms of effectiveness because the half life was long enough to take once daily, regardless of formulation.

[XMPPwocky]

Re: "no one is forcing customers to pick the once weekly over the once daily"-

Who's the customer here, the prescriber or the patient? Is a prescription for the weekly formulation valid for the daily one too?