Recent comments in /f/askscience

Aseyhe t1_jaqbsge wrote

Reply to comment by Inside_Olive5504 in Why do cosmologists say that gravity should "slow down" the expansion of the universe? by crazunggoy47

> An argument can be made that gravity exerts no net force, just using Newton's law and symmetry.

That's what Newton believed, but a more careful look reveals that the integral over all space that determines the gravitational force does not converge to a well defined value. See for example the dynamics of Newtonian cosmology.

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Gwinntanamo t1_jaq79an wrote

Reply to comment by BellaBlue06 in The Vyvanse patent expires this year. How long does it usually take generic alternatives to get approved, and how much of a reduction in cost is expected on average? by paleselan1

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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somdude04 t1_jaq6tvs wrote

Reply to comment by SNRatio in The Vyvanse patent expires this year. How long does it usually take generic alternatives to get approved, and how much of a reduction in cost is expected on average? by paleselan1

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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Andrew5329 t1_jaq6gyk wrote

Reply to The Vyvanse patent expires this year. How long does it usually take generic alternatives to get approved, and how much of a reduction in cost is expected on average? by paleselan1

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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mineralphd t1_jaq45ci wrote

Reply to The Vyvanse patent expires this year. How long does it usually take generic alternatives to get approved, and how much of a reduction in cost is expected on average? by paleselan1

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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