Lilly holds the patent — so how do gray vendors move this stuff?

gimmeshelter

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Can anyone explain how China is able to produce Reta while the product has not even launched and Lilly holds the patent? Then gray vendors wave around janoshik tests as proof it is safe and legit. Never understood how that works. Is it simply a chemical company getting hold of a Lilly sample and then engineering an identical product off it?

Any info would be appreciated !
 
Through chemistry, naturally! And with zero concern for legal markets or patent protections.

I'm not a chemist myself, but my understanding is that the process works roughly like this:

The molecular structure gets made public through the FDA approval process. Peptides aren't that hard to synthesize — which explains why Grey doesn't carry, say, the trickier treatments whose names end in -mab, i.e. monoclonal antibodies.
 
https://ebay.us/m/KaUz9k

I've had my eye on this peptide sequencer listed on eBay — it's a decent one. Since peptides are nothing more than amino acid chains that carry biological signals between different parts, and there are only 20 amino acids to work with, the two of you could produce your own peptides right at home.

Making peptides isn't the hard part; the real cost comes from processing, sterilizing the vials and stoppers, filling the liquid product, and then lyophilization. Any one of those steps can fail or introduce contamination.

It's during final filling and lyophilization that economies of scale truly take over.
 
indolent said:

Through chemistry, naturally! And with zero concern for legal markets or patent protections.

I'm not a chemist myself, but my understanding is that the process works roughly like this:

The molecular structure gets made public through the FDA approval process. Peptides aren't that hard to synthesize — which explains why Grey doesn't carry, say, the trickier treatments whose names end in -mab, i.e. monoclonal antibodies.
That's helpful, appreciate it!
 
gimmeshelter said:

Can anyone explain how China is able to produce Reta while the product has not even launched and Lilly holds the patent? Then gray vendors wave around janoshik tests as proof it is safe and legit. Never understood how that works. Is it simply a chemical company getting hold of a Lilly sample and then engineering an identical product off it?

Any info would be appreciated !
When applying for a patent, the applicant is required to disclose the subject matter being patented.
 
MsGizmo said:

gimmeshelter said:

Can anyone explain how China is able to produce Reta while the product has not even launched and Lilly holds the patent? Then gray vendors wave around janoshik tests as proof it is safe and legit. Never understood how that works. Is it simply a chemical company getting hold of a Lilly sample and then engineering an identical product off it?

Any info would be appreciated !
When applying for a patent, the applicant is required to disclose the subject matter being patented.
Got it — that clears things up! Thanks
 
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