Tag: Hatch-Waxman Act
First Generic vs Authorized Generic: How Timing of Market Entry Changes Everything
First generics and authorized generics may look the same, but their market entry timing creates a huge difference in pricing and competition. Learn how brand companies use authorized generics to undercut true generic rivals.
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Paragraph IV Certifications: How Generic Drug Makers Legally Challenge Brand-Name Patents
Paragraph IV certifications let generic drug makers legally challenge brand-name patents before launch. This Hatch-Waxman Act tool drives down drug prices by enabling 180-day market exclusivity for the first challenger - but it comes with high legal risks and complex rules.
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