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Comment by refurb | Hacker News Reader

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.

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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.

> 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.

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