GDF2026 - Addressing Patent and Exclusivity Requirements – Regulatory Reminders
U.S. Food and Drug Administration, Office of Generic Drug Policy · July 30, 2026
A member of FDA's Office of Generic Drug Policy, Heather Strandberg, reviewed common patent exclusivity deficiencies for ANDA applicants, including handling later-listed patents and use codes, Paragraph IV notice and documentation, notification requirements for legal actions and commercial marketing, pediatric exclusivity, and public FDA resources.
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