The Patent Timeline
Ozempic FDA Approval
Novo Nordisk receives approval for semaglutide injection for type 2 diabetes
Wegovy FDA Approval
Higher-dose semaglutide approved for chronic weight management
Mounjaro FDA Approval
Eli Lilly's tirzepatide approved for diabetes
Generic Liraglutide Launches
First generic GLP-1 becomes available (Saxenda equivalent)
Generic Semaglutide (Expected)
Core patents expire; generic competition expected to begin
Generic Tirzepatide (Expected)
Mounjaro/Zepbound generics expected even later
Why So Long?
Pharmaceutical patents typically last 20 years from filing, but the timeline from filing to FDA approval can extend effective exclusivity. Novo Nordisk holds multiple patents on semaglutide covering:
- The semaglutide molecule itself
- Manufacturing processes
- Delivery mechanisms (injection devices)
- Specific formulations
Generic manufacturers must wait for key patents to expire AND prove their version is bioequivalent before receiving FDA approval.
What's Available Now
| Option | Status | Price |
|---|---|---|
| Generic Liraglutide | ✓ Available now | ~$200-400/mo |
| Brand Semaglutide (NovoCare) | ✓ Available | $349/mo |
| Brand Tirzepatide (LillyDirect) | ✓ Available | $299-449/mo |
| Compounded Semaglutide | ⚠️ Regulatory uncertainty | $149-299/mo |
| Generic Semaglutide | ✗ 2031-2032 | TBD |
International Generics
Generic semaglutide is already manufactured in countries like China and India, where patent protections differ. However:
- Not FDA-approved for sale in the US
- Importing is illegal in most circumstances
- Quality/safety concerns without FDA oversight
- No doctor supervision for dosing and side effects
We don't recommend this route due to legal and safety risks.
What Should You Do Until 2031?
1. Check insurance coverage. Even with high denial rates, some plans cover GLP-1s, especially for diabetes.
2. Use manufacturer programs. NovoCare ($349/mo) and LillyDirect ($299-449/mo) make brand medications more accessible.
3. Consider compounded options. While regulatory uncertainty exists, compounded GLP-1s remain available at $149-299/month from telehealth providers.
4. Ask about liraglutide. Generic liraglutide is available now and may be appropriate for some patients.
5. Watch for policy changes. Medicare BALANCE Model (July 2026) and potential drug pricing reforms could improve access.
Find Your Best Option Today
Don't wait until 2031. Compare current prices and savings programs.
View Current Options →