Jul. 14 at 12:51 AM
$IPIX Okay, I should have kept reading 🙄
The Bolar Exception (Safe Harbor): Under the Hatch-Waxman Act, third parties (such as generic manufacturers) can use a patented drug to conduct tests and gather data for FDA approval. This protects generic or biosimilar drugs from infringement claims while they prepare to enter the market.
Patent Expiration: Patents typically last for 20 years from the earliest filing date. Once a patent expires, anyone is free to make and sell the drug, provided they have FDA
Patent Expiration: Patents typically last for 20 years from the earliest filing date. Once a patent expires, anyone is free to make and sell the drug, provided they have FDA approval.