Why pay to get FDA approval, if you don't get a government granted monopoly on it afterwards?
This is one problem with using patents as the mechanism to incentivise development of medicine.
If there's an actual natural, identified substance with huge benefits to people, it's going to go gangbusters and you're going to make a lot, LOT of money selling it, even if you're doing it via roadside lemonade stand.
It feels like this claim is usually used to promote cures and treatments with extremely low quality RCTs backing their use as a sort of panacea.
I used to believe the "just do shrooms to cure depression" claims on principle until I looked into the quality of those studies, which is very low. At that point, you're just making stuff up.
Kratom, CBD, and delta-8 THC are naturally occurring bioactive substances that are newer to the US market. Both have carved out a pretty nice economic niche with a bunch of claimed health benefits.
A couple of years back, I saw a sign outside a fancy legal highs shop in Fishtown, Philadelphia touting the benefits of kratom as a pre-workout supplement. The insanity that a business was advertising an addictive opioid to healthy, opioid-naive people for better gains in the gym almost makes me want more regulation in this area.
Even synthetic research chemicals are generally legal as long as you add a "not for human consumption" label (and they aren't explicitly banned or analogous to other illegal/regulated drugs).
For example, there's a prescription engineered version of melatonin.
Melatonin is still a huge business.
Clinical trials are a significant expense in developing a drug. Kind of makes me think we should award patents not for coming up with some molecule, but instead award them for showing a molecule is safe and effective.
In any case, none of that refutes that there is a strong economic incentive for market actors to not fund FDA approval trials since any benefit will be shared by the entire market.
You can buy a 3 month supply of Lithium Orotate for like $10. I certainly wouldnt recommend self prescribing this kind of thing though.
You have to dose relatively high in order to have an effect. You’re disrupting your neural sodium-potassium pumps with it.
But it’s still pretty cheap. Hard to charge a lot for a fairly abundant element.
The substance in question is a peptide. It's not something you simply extract from a plant using a solvent. OTOH, being a peptide, it's likely easy enough to produce in a genetically engineered bacterium or yeast. Efficient extraction may remain a problem though, because you'll need to select a particular protein fragment (the peptide) from reams of other protein fragments of the bacterial / fungal cells you process.
Giving yourself an injection an hour before you eat or an hour before you are hungry isn’t going to work.
https://patents.google.com/?inventor=Katrin+Svensson
It would seem they are modifying peptides. Which is patentable.
Even without a patent, companies can get FDA exclusivity but for not as long as a patent grants them so unless the addressable market is huge, it’s a financially riskier bet.
Supplements are a $50bn business [1].
[1] https://www.grandviewresearch.com/industry-analysis/us-dieta...
The history from wikipedia
The first medical use of fumaric acid was described in 1959 by Walter Schweckendiek, a German chemist, and was a topical formulation for psoriasis. The Swiss company Fumapharm eventually brought Fumaderm, an oral formulation of dimethyl fumarate (along with some monoesters) to market for psoriasis in Germany in 1994.
Based on the efficacy and safety of this formulation, and evidence that dimethyl fumarate was the main active component, an oral formulation of dimethyl fumarate was developed by Almirall. This oral formulation, under the brand name Skilarence, was approved by the European Medicines Agency (EMA) in June 2017, for the treatment of moderate-to-severe plaque psoriasis in adults.
Initial clinical research on the use of dimethyl fumarate for the treatment of multiple sclerosis was conducted by Fumapharm in collaboration with Biogen Idec; Fumapharm was subsequently acquired by Biogen Idec in 2006. Aditech Pharma in Sweden had also been researching oral formulations of dimethyl fumarate for MS and in 2010, the Danish company Forward Pharma acquired Aditech's patents.
Like, less likely than they would be to pay Ozempic to use their patent? I mean, I could believe that if there weren't like Billions of dollars being funneled into weight-loss programs and foods that don't have any demonstrative weight-loss capabilities.
If this actually works and is naturally occurring, I'd be surprised if there weren't like enterprising startups and food companies adding this to existing products within a year or 2.