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Pharmaceutical Patent Disputes: Generic Entry for Small-Molecule Drugs Under the Hatch-Waxman Act

Published Jun 12, 2025Updated Jun 21, 2025

The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.

Pharmaceutical Patent Disputes: Generic Entry for Small-Molecule Drugs Under the Hatch-Wax… — Informed