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Comment by new299 | Hacker News Reader

I didn’t really understand this comment so I dig into it a bit more. Here is my current understanding…

In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.

To avoid genetics being produced companies withdraw products where patent coverage has expired. They then release a new product which is substantially the same and has no or minor benefits, but is covered by patents.

Because the old product is no longer on the market, the FDA will not approve a generic. Even though the exact same product /was/ on the market.

This seems like a weird interaction between patents and the FDA rules which wouldn’t occur in the same way elsewhere (seems like the FDA rules kind of suck to me at first glance).

There’s more information in the lawsuit here:

https://casefilingsalert.com/wp-content/uploads/2022/08/GSK-...

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> In the US to market a generic you need to show that it’s the same as an existing approved product currently on the market.

On a related note, you don't need to show that it's actually the same, just that it's close enough. And that doesn't always work out for the best. An easy example being anticonvulsants. My younger brother died from an epileptic seizure and post-death examination determined the active ingredient of the anticonvulsant he was taking wasn't present in his blood. He had just been switched from brand-name to generic. Come to find out that this is/was a known issue that the FDA hadn't figured out how to solve. The generics aren't made using the same process and the end result isn't identical to the real drug.

This is something nobody knows how to solve. The best health agencies manage to do is prohibiting some manufacturing procedure after it was shown that things built with it are ineffective.

> Because the old product is no longer on the market, the FDA will not approve a generic. Even though the exact same product /was/ on the market.

This isn't the case, it doesn't need to still be on the market.

However if the approved product was produced with chemicals that are now banned (or the approved drug itself was banned) - then you _can't_ make a generic because you would have to use a banned chemical to do it.

---

Similar shenanigans to prevent generics include slightly modifying existing generics like ketamine for example, before getting it approved for depression treatment. You cannot patent ketamine for depression, so you can slightly modify it and patent that instead.

Because the old product is no longer on the market, the FDA will not approve a generic.

That's not a requirement to get a generic approved.

As long as a molecule has been approved before (through a New Drug Application), all follow-on drugs get approved through an ANDA (Abbreviated New Drug Application).

The real reason why inhalers are so hard to make generics for is that it's not just a drug - it's a delivery system, which is way more technologically complex than just producing a bunch of a chemical and putting it in pills.

Generic companies aren't interested in the investment. Having a factory make a ton of drug is cheap for the most part. You can put it in pills can cost a few cents per pill.

Investing in a new inhaler device is a major investment. Kind of similar to how generic injectable drugs is not as attractive - the investment is much higher.

> As long as a molecule has been approved before (through a New Drug Application), all follow-on drugs get approved through an ANDA (Abbreviated New Drug Application).

But there are shenanigans that can happen there. IIRC, to get a new generic approved, you have to demonstrate it's the same as the existing generics, which requires a supply of that drug. Years ago I read a company (it might have been one of Martin Shkreli's) that played a trick with that:

1. they manufactured a generic drug,

2. put extreme restrictions on its supply chain so no competitor could get ahold of enough of their product to do the equivalency testing, and

3. jacked up the price to an extreme degree.

The lawsuit implies that inhalers are a special case, where the normal FDA rules don’t apply. By adding new patents covering inhalers the manufacturer triggers FDA rules preventing the FDA from approving a generic, or so the lawsuit implies:

Because of the complexities of producing drug-device combinations like inhalers, the Food and Drug Administration employs a special set of regulatory requirements when approving generic inhalers.

Specifically, when a brand-name manufacturer lists a patent for a product with the Food and Drug Administration (FDA), the FDA is prohibited from approving the generic version of that product until the patent protection expires or is challenged and overturned.

Sure, because inhalers aren't just drugs, they are drug-device combinations.

If someone wants to make a generic, not only does the drug patent need to expire, but also the device patent.

But nothing stops a company from developing their own device. The issue is that it won't be a generic - it will be a new inhaler.

That's expensive to do.

* generic

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