Tag: Paragraph IV certification
Hatch-Waxman Act Explained: How the 1984 Law Balances Brand and Generic Drugs
By Joe Barnett On 24 Jun, 2026 Comments (0)
Explore how the Hatch-Waxman Act of 1984 revolutionized US drug policy by balancing patent protections for innovators with streamlined approvals for generics, lowering costs and increasing access.
View MoreParagraph IV Certifications: How Generic Drug Companies Challenge Patents Early
By Joe Barnett On 8 Jan, 2026 Comments (8)
Paragraph IV certifications let generic drugmakers challenge brand patents before launch, speeding up access to affordable medicines. Learn how this legal tool works, why it saves billions, and how big pharma fights back.
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