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Tag: FDA approval

Patent Term Restoration: How Pharmaceutical Companies Legally Extend Drug Exclusivity
Medical Research and Development
12

Patent Term Restoration: How Pharmaceutical Companies Legally Extend Drug Exclusivity

January 4, 2026 by Maxwell Harrington

Patent term restoration lets pharmaceutical companies recover time lost during FDA approval, extending drug exclusivity by up to five years. Learn how the Hatch-Waxman Act works, who qualifies, and why it's critical for drug innovation.

Recent Patent Cases and Generic Delays: 2023-2025 Examples
Medical Research and Development
12

Recent Patent Cases and Generic Delays: 2023-2025 Examples

December 15, 2025 by Maxwell Harrington

Between 2023 and 2025, patent lawsuits have become the main reason generic drugs are approved but never reach pharmacies. Patients pay thousands more each month while brand companies extend monopolies through legal tactics.

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