Understanding Branded Drugs vs. Compounded Versions

1. Branded Drugs Overview

   • Branded drugs like Ozempic, Weagovy, Monjuaro, and ZepBound are owned by Big Pharma.

   • FDA approval for specific treatments (diabetes or obesity) allows marketing for those indications.

2. Semaglutide vs. Tirzepatide

   • Ozempic and Weagovy contain Semaglutide, while Monjuaro and ZepBound contain Tirzepatide.

   • Despite different branding, they are essentially the same medication with different dosages.

3. Compounded Versions

   • Normally, compounded versions of branded drugs with FDA approval are not allowed due to patents.

   • FDA shortage list exception allows compounded versions if certain criteria are met by pharmacies.

4. Legal Compounding

   • Compounded versions of Semaglutide and Tirzepatide are currently allowed due to being on the FDA shortage list.

   • Tirzepatide’s patent until 2027 restricts compounding unless on the shortage list.

5. Future Outlook

   • Semaglutide’s patent expired in 2023, potentially allowing continued compounding even if off the shortage list.

   • Some pharmacies are challenging the rules to ensure availability of Tirzepatide even after the patent expires in 2027.

6. Summary

   • Understanding the differences between branded drugs and compounded versions.

   • Legalities and regulations governing the compounding of medications like Semaglutide and Tirzepatide.

   • Future implications for the availability of these medications based on patents and FDA regulations.