Tag: ANDA

180-Day Exclusivity: How Patent Law Blocks Generic Drug Entry
Pharmacy

180-Day Exclusivity: How Patent Law Blocks Generic Drug Entry

The 180-day exclusivity rule was meant to speed up generic drug access-but often delays it. Learn how patent law, FDA rules, and corporate strategy combine to block affordable medications.

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity
Pharmacy

Why the First Generic Drug Filer Gets 180 Days of Market Exclusivity

The first generic drug filer gets 180 days of exclusive market rights under the Hatch-Waxman Act. This rule was meant to lower drug prices-but loopholes let companies delay competition. Here’s how it works, who benefits, and why reform is overdue.

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