Patent Certification and Exclusivity under Hatch-Waxman
Patent Certification and Exclusivity under Hatch-Waxman Navigating Patent Certification and Exclusivity in ANDA Submissions Introduction to Hatch-Waxman Framework The Hatch-Waxman Act, formally known as the Drug Price Competition and Patent Term Restoration Act of 1984, created a regulatory pathway for generic drugs while preserving the intellectual property rights of brand-name manufacturers. It established the Abbreviated…
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