I'm confused - wouldn't the new patent only cover the improved method, and the patent on the original, un-improved version would still expire?
The article says some people need up to 6 of those vials per month. So, it can still end up being $1,800 per year.
Other non-US countries are able to provide a yearly supply of the newer biosimilar insulin for just $72-133 per year: https://gh.bmj.com/content/3/5/e000850
The real issue is that nobody has an incentive to prescribe the older, less good but still acceptable drug. (In the case of insulin, note, it’s not only the delivery mechanisms that have improved, but the insulin itself.) the insurance company, in particular, under the ACA, have no incentive to cut costs to improve profits.
Evergreening is absolutely a thing, and absolutely planned and executed by the companies that profit from it.
https://www.fda.gov/drugs/questions-answers/transition-cfc-p...
However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
However, there is a workaround: compounding pharmacies. To my knowledge, accredited compounding pharmacies can make, on a customer-by-customer basis, any product that the FDA has ever approved. And many of them are mail-order pharmacies. In my experience, prices are comparable to mass-market generics, or lower.
>However, if a brand manufacturer has an old product delisted, then physicians can no longer prescribe generic equivalents. That's become more and more common.
Why is the ability to prescribe a drug tied to whether the branded version in still "listed"?
Also: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
And: https://www.drugs.com/history/
Physicians can only prescribe FDA-approved drugs. Only brand drugs are approved on their own. Generic drugs are approved, with much less documentation required. There's no need to demonstrate effectiveness, safety, etc. Applicants must only demonstrate that products are therapeutically equivalent to approved brand drugs. That's mainly about chemical identity, purity, and rate and degree of absorption.
At Drugs@FDA, search for a brand name. If there are generics, you'll see "Therapeutic Equivalents for NDA ...". Clicking that will display links to them.
If there's no listed brand drug, there's nothing for a generic to be equivalent to.
But the real reason is almost always that they have a new version, which costs much more, and they don't want competition from inexpensive generics to their old product.
There have been some antitrust suits over that. I don't know how they turned out.
The issue is that doctors keep proscribing the newer, slightly improved methods.
Trying to evergreen on purpose is also dangerous since your competitor can patent an improvement on your invention. I somewhat doubt it is a purposeful strategy. But rather it just reflects the iterative nature of invention.
Plus developing a product from the old patent still requires extensive FDA approval. Very expensive stuff.
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.
Who's the customer here, the prescriber or the patient? Is a prescription for the weekly formulation valid for the daily one too?
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.