3 ms·

I have to admit that I'm baffled as to what is happening here. Semaglutide is still under patent protection, so anyone producing feedstock is doing so under lic

I have to admit that I'm baffled as to what is happening here. Semaglutide is still under patent protection, so anyone producing feedstock is doing so under license with Nova Nordisk. Why on earth would NN offer licensing terms that allow them to sell the feedstock to anyone but NN? There are no generic manufacturers because the patent is still active. Compounding pharmacies are getting the drug from the feedstock producers, but how on earth are they contractually permitted to sell it?

sithadmin 2y ago
Your usage of the term 'feedstock' here is confusing, and it seems like you're probably operating under the erroneous assumption that contract manufacturer supplies commissioned by Novo Nordisk are somehow being routed to compounding pharmacies, which isn't the case. In practice, there are generic manufacturers for semaglutide, and many other peptides still protected by US patents, mostly located in China. The more reputable of these manufacturers produce these drugs at levels of purity rivaling the 'name brand'. These manufacturers export lyophilized product en masse to middlemen that operate in the grey/black-market 'research chemical' sales market, or ship to compounding pharmacies. The consumers purchasing on the grey/black market reconstitute the drug at home (which requires a trivial level of effort), and assume some extra degree of risk in terms of product purity and sterility. Consumers wanting an extra level of assurance for product quality purchase from a compounding pharmacy that ostensibly is conducting its own assessments of product purity, and following best practices for sterile reconstitution.
- andrewla 2y ago
  I don't think this is true. Henry's, one of the compounding pharmacies, says that they get the chemicals from legitimate licensed producers of feedstock [1]. There is a compounding loophole, but there is no loophole for patent encumbrances -- if a compounding pharmacy is violating NN's intellectual property, then can just sue them directly; they don't have to pursue the regulatory crackdown they're going for now. There are companies that do grey/black market reconstitutions, like Pivotal Peptides. But they are not compounders. The compounders are legally selling the real thing directly to customers. Do you have a specific source that indicates that any compounding pharmacy is getting its feedstock illegally from China? [1] https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/kr9ggwr/ https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/..., discovered via https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole
  - cthalupa 2y ago
    Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-maker-novo-nordisk-sues-nine-spas-clinics-pharmacies-over-copycat-drugs-2024-05-30/ https://www.reuters.com/business/healthcare-pharmaceuticals/... https://www.fiercepharma.com/pharma/lilly-files-complaints-against-8-companies-making-and-selling-compounded-versions-mounjaro https://www.fiercepharma.com/pharma/lilly-files-complaints-a... Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss https://www.fda.gov/drugs/postmarket-drug-safety-information...
    - andrewla 2y ago
      Hey, thanks -- this is great stuff! I tried looking around at these links but I couldn't find the actual lawsuit itself, and I'm curious what they specifically say. There's a difference between saying that a compounding pharmacy is selling junk claiming that it is semaglutide (that is, making false claims that may reflect on NN when the substance is ineffective), vs. claims that the drug is being produced in violation of their intellectual property rights for the synthesis of the drug.
      - throwup238 2y ago
        You can just search for the the phrase "Novo Nordisk v [company name]". For example: NOVO NORDISK INC. v AESTHETIC MAISON LLC and AESTHETIC CASA LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-Aesthetic-Maison-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK INC. v MEDIOAK PHARMACY LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK A/S AND NOVO NORDISK INC. v BOF MEDICAL CENTER, INC.: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-BOF-Medical-Center-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... In the Aesthetic Maison and Medioak pharmacy cases, Novo Nordisk alleges that they're selling a product claiming to contain semaglutide without a prescription or FDA approval. In the BOF Medical case, they're claiming "trademark infringement, false advertising, and unfair competition." They're not suing for damages, just injunctive relief ordering the defendants to stop. It doesn't look like it even matters to their cases whether the products contain real semaglutide.

sithadmin 2y ago

Your usage of the term 'feedstock' here is confusing, and it seems like you're probably operating under the erroneous assumption that contract manufacturer supplies commissioned by Novo Nordisk are somehow being routed to compounding pharmacies, which isn't the case. In practice, there are generic manufacturers for semaglutide, and many other peptides still protected by US patents, mostly located in China. The more reputable of these manufacturers produce these drugs at levels of purity rivaling the 'name brand'. These manufacturers export lyophilized product en masse to middlemen that operate in the grey/black-market 'research chemical' sales market, or ship to compounding pharmacies. The consumers purchasing on the grey/black market reconstitute the drug at home (which requires a trivial level of effort), and assume some extra degree of risk in terms of product purity and sterility. Consumers wanting an extra level of assurance for product quality purchase from a compounding pharmacy that ostensibly is conducting its own assessments of product purity, and following best practices for sterile reconstitution.

andrewla 2y ago
I don't think this is true. Henry's, one of the compounding pharmacies, says that they get the chemicals from legitimate licensed producers of feedstock [1]. There is a compounding loophole, but there is no loophole for patent encumbrances -- if a compounding pharmacy is violating NN's intellectual property, then can just sue them directly; they don't have to pursue the regulatory crackdown they're going for now. There are companies that do grey/black market reconstitutions, like Pivotal Peptides. But they are not compounders. The compounders are legally selling the real thing directly to customers. Do you have a specific source that indicates that any compounding pharmacy is getting its feedstock illegally from China? [1] https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/kr9ggwr/ https://www.reddit.com/r/henrymeds/comments/1av14cm/comment/..., discovered via https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole
- cthalupa 2y ago
  Why are Eli Lilly and Novo Nordisk suing compounding pharmacies, then? https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-maker-novo-nordisk-sues-nine-spas-clinics-pharmacies-over-copycat-drugs-2024-05-30/ https://www.reuters.com/business/healthcare-pharmaceuticals/... https://www.fiercepharma.com/pharma/lilly-files-complaints-against-8-companies-making-and-selling-compounded-versions-mounjaro https://www.fiercepharma.com/pharma/lilly-files-complaints-a... Why is the FDA warning that some compounding pharmacies are using the salt forms of semaglutide and tirzepatide? https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss https://www.fda.gov/drugs/postmarket-drug-safety-information...
  - andrewla 2y ago
    Hey, thanks -- this is great stuff! I tried looking around at these links but I couldn't find the actual lawsuit itself, and I'm curious what they specifically say. There's a difference between saying that a compounding pharmacy is selling junk claiming that it is semaglutide (that is, making false claims that may reflect on NN when the substance is ineffective), vs. claims that the drug is being produced in violation of their intellectual property rights for the synthesis of the drug.
    - throwup238 2y ago
      You can just search for the the phrase "Novo Nordisk v [company name]". For example: NOVO NORDISK INC. v AESTHETIC MAISON LLC and AESTHETIC CASA LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-Aesthetic-Maison-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK INC. v MEDIOAK PHARMACY LLC: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-MedioakPharmacy-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... NOVO NORDISK A/S AND NOVO NORDISK INC. v BOF MEDICAL CENTER, INC.: https://www.safemedicines.org/wp-content/uploads/2019/09/Novo-Nordisk-v-BOF-Medical-Center-Complaint.pdf https://www.safemedicines.org/wp-content/uploads/2019/09/Nov... In the Aesthetic Maison and Medioak pharmacy cases, Novo Nordisk alleges that they're selling a product claiming to contain semaglutide without a prescription or FDA approval. In the BOF Medical case, they're claiming "trademark infringement, false advertising, and unfair competition." They're not suing for damages, just injunctive relief ordering the defendants to stop. It doesn't look like it even matters to their cases whether the products contain real semaglutide.