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LOERadar

FDA drug patent and exclusivity intelligence, assembled from public records.

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© 2026LOERadar · An informational research tool drawn from public records; it is not a law firm, does not provide legal advice, and its use does not create an attorney-client relationship.

NCE Expirations

New Chemical Entity exclusivity expirations with ANDA filing windows (NCE-1 dates) and annual Medicare Part D spending. NCE expiry is the earliest date FDA can accept a standard ANDA (NCE-1 for Paragraph IV filings) — a filing milestone, not a generic-entry or loss-of-exclusivity date.