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Tag: Hatch-Waxman Act

Paragraph IV Certifications: How Generic Drug Makers Challenge Patents Before Launch
Posted by Larissa Drayton in Medications Comments 1

Paragraph IV Certifications: How Generic Drug Makers Challenge Patents Before Launch

Paragraph IV certifications let generic drug makers challenge brand-name patents before launch, speeding up access to cheaper medications. This legal tool under the Hatch-Waxman Act has saved U.S. consumers trillions and reshaped the pharmaceutical market.

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