Tag: Paragraph IV certification

180-Day Exclusivity and Authorized Generics: Legal Risks and Market Impact 3 Jan
By: Finnegan Blackwood
10

180-Day Exclusivity and Authorized Generics: Legal Risks and Market Impact

The 180-day exclusivity rule for generic drugs was meant to reward patent challengers - but authorized generics let brand-name companies undercut them. Here's how the law works, why it's failing, and what's being done to fix it.

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