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ozwegoe t1_japram1 wrote

Depends. The manufacturer could sue or do something to put the patent in a holding pattern to extend the patent life until all legal issues are resolved.

But generally the generic will come out pretty quickly (especially if the manufacturer also makes generics).

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blackandgay676 t1_japvmhj wrote

The cost reduction part is highly dependent on the number of generic makers who want to get in.

I work in HIV prevention and the first generic of Truvada went from 2000 for brand name to ~1400 for generic because for the first 6 months there was only one generic drug maker. After those 6 months were up the price plummeted and I think now list price for it is anywhere from 30-100 bucks.

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RabbitFuzz t1_japxxdb wrote

It looks like there are a couple of companies that have applications in with the FDA for the generic version.

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

Look up the generic name lisdexamfetamine and it has a couple of companies that have tentative approvals, like Actavis, Roxane, TEVA, Amneal, Myan, Sandoz and Norwich.

Even with approval, depending on the company, it might come out later or as others have mentioned, the company could sue others.

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the_fungible_man t1_japz7vm wrote

Replying to RabbitFuzz (#2,149,642)

Following that link, it appears that the Vyvanse patents expired on February 24^th . It will be interesting to see whether and how quickly these other manufacturers are able to bring a generic to the market.

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The_frozen_one t1_jaq1x14 wrote

Replying to ozwegoe (#2,149,383)

They can't extend the life of the patent. They can claim that the process for making the drug is patented, and they can claim multiple steps in the process to make the drug are patented. Generic companies would have to see if they can make the drug without violating these patents, or they might have to challenge them.

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BellaBlue06 t1_jaq21lx wrote

Replying to the_fungible_man (#2,149,686)

The main patent expired Feb 24. But they are granted 6 months beyond that for exclusivity still for pediatric patients and supposed to use this time to study effects on kids. Basically most drug companies get a 6 month extension for pediatrics as they delay generics getting a chance and get extra time to rake in full price money and pretend to be studying effects on kids even if they’ve already had a decade to do so. So we have to wait til after Aug 24 2023.

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mineralphd t1_jaq45ci wrote

Assuming no remaining patent issues, generics will start right away. However, as an incentive, one generic manufacturer will be granted exclusivity for six months where the price will not drop much. After that, the more popular the drug, the more competition and the price will drop considerably. But in the past ~10 years, generic prices have risen sharply. https://www.fda.gov/drugs/cder-small-business-industry-assistance-sbia/small-business-assistance-180-day-generic-drug-exclusivity

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Andrew5329 t1_jaq6gyk wrote

I work in the industry, it mostly depends on the class of the drug. Drugs derived from traditional "small molecule" chemistry tend to be a lot faster than "large molecule" biologics. A "large" small molecule like Lipitor might be made from around a hundred individual atoms and have a mass of about 1,000 Daltons. A Biologics derived drug like Humira might be around 150,000 Daltons, or more depending on what it is.

From a manufacturing perspective the complexity of a small molecule is on the relative scale of creating identical bicycles vs building an identical aircraft carrier. The first is a challenge, but you can usually prove atom by atom that the new product is in fact identical meaning it can go for sale quickly. The latter is actually impossible, no two ships are identical in final construction and that's assuming they're from the same shipyard. A rival country trying to recreate an aircraft carrier from scratch? No chance it's the same. So what the rivals actually do is try to produce a "biosimilar" and bring that to market. That involves a hell of a lot more work and a lot of long expensive clinical studies proving that thir biosimilar is no-par with the original product.

A secondary factor is market size. There's a fixed cost to setting up a production line, if the drug is for a rare disease then you're splitting the cost fewer ways.

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somdude04 t1_jaq6tvs wrote

Replying to SNRatio (#2,149,916)

That's because we have a rule in place to give that first generic a 180 say exclusivity benefit because they were first, where they still price gouge because the only price they need to beat is the name brand one, and only barely.

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Gwinntanamo t1_jaq79an wrote

Replying to BellaBlue06 (#2,149,792)

That’s not how it works. The 6-month extension is granted if the company conducts a study in pediatrics at any point in time. I haven’t looked, but I assume Vyvanse is actually indicated for some pediatric patients already (most ADHD drugs are). The extension is simply an incentive young kids - a patient segment that is often under studied with new products.

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