Hello everyone!
I’ve been preparing to share more insights on pharmaceutical regulations in the future, and today I’ve learned about patents, FDA approvals, and how generics enter the market.
How Patent Protection Works
Patent Duration
- Patents protect drugs from direct competition for 20 years.
FDA Approval Time
- The FDA approval process can take 8 to 10 years, leaving an effective patent life of about 10 to 12 years for the company to market their product.
What Happens After the Patent Expires?
- Once the patent expires, generic drugs can enter the market. In US, This is regulated under the Drug Price Competition and Patent Restoration Act (also known as the Hatch-Waxman Act).
Generic Drug Applications
- Generic companies file an Abbreviated New Drug Application (ANDA).
- They only need to prove bioequivalence to the original drug, not repeat clinical trials. I have inspected a number so such trials!
Market Exclusivity for Generics
- The first generic manufacturer to gain approval gets 180 days of market exclusivity, meaning they are the only generic available for six months.
Why This Matters
- Innovation: Patents give companies time to recoup research and development costs.
- Affordability: Generics make treatments more accessible once patents expire.
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