Tag: Hatch-Waxman Act

Patent Law and Generics: How Patents Protect Innovation in Drug Development

Patent Law and Generics: How Patents Protect Innovation in Drug Development

  • Feb, 8 2026
  • 11

Patent law balances innovation and access by giving drug makers temporary exclusivity, which funds R&D, while enabling generics to enter after patents expire-saving billions and making medicines affordable.

What Is an ANDA? The Complete Guide to Generic Drug Approval by the FDA

What Is an ANDA? The Complete Guide to Generic Drug Approval by the FDA

  • Feb, 2 2026
  • 10

An ANDA is the FDA pathway that allows generic drugs to enter the market without repeating costly clinical trials. It’s how 90% of U.S. prescriptions are filled at a fraction of the cost.