Tag: Hatch-Waxman Act

December 6, 2025

First Generic vs Authorized Generic: How Timing of Market Entry Changes Everything

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First generics and authorized generics enter the market differently, with timing playing a crucial role in pricing and competition. Authorized generics, launched by brand companies, often undercut first generics during their 180-day exclusivity window, reducing price drops and undermining the intended incentive of the Hatch-Waxman Act.

November 17, 2025

Litigation in Generic Pharmaceutical Markets: How Patent Disputes Delay Affordable Medicines

by Casper Thornebridge

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Patent litigation in the generic drug market is delaying affordable medicines by years, not protecting innovation. Learn how the Hatch-Waxman Act, Orange Book listings, and pay-for-delay deals are shaping access to life-saving drugs.