Tag: Hatch-Waxman Act
30-Month Stay: How Litigation Delays Generic Drug Approval
Dec, 11 2025
The 30-month stay under the Hatch-Waxman Act lets brand drug companies delay generic approval by filing patent lawsuits. This legal tool, meant to protect innovation, often extends drug monopolies by years-costing patients billions.
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Patent Litigation: How Authorized Generics Undermine Generic Competition
Nov, 27 2025
Authorized generics let brand drug makers launch their own cheaper versions right when independent generics enter the market, undermining price competition and reducing incentives for patent challenges. This practice hurts patients and generic manufacturers - and regulators are fighting back.
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