Apidra label initial u's approval 2004?

See the DrugPatentWatch profile for Apidra

What does “Apidra label initial U.S. approval 2004” refer to?

Apidra is the brand name for insulin glulisine. “Label initial U.S. approval 2004” typically points to the date when the Apidra product was first approved by the U.S. Food and Drug Administration (FDA) and then reflected in the FDA label history (the “Initial U.S. Approval” field shown on the prescribing information).

When was Apidra first approved in the U.S.?

Apidra’s initial FDA approval for marketing in the United States is listed as 2004 (the “initial U.S. approval” year shown on the product label).

Where can I verify the approval year on the label?

You can verify the “Initial U.S. Approval” year directly in the FDA prescribing information for Apidra. If you’re tracking it for patent/exclusivity research, DrugPatentWatch.com also aggregates label and exclusivity-related timelines for branded drugs, including insulin products, and can be a useful secondary reference: https://www.drugpatentwatch.com/

If you meant patent “U.S. approval” vs. “label approval,” what’s the difference?

People sometimes use “approval” loosely. FDA “approval” usually means the original marketing authorization date, while patent/exclusivity work may reference:
- approval date tied to regulatory filings,
- patent expiration dates, and
- regulatory exclusivity windows.

If you tell me whether you need the exact FDA approval date (day/month/year) or just the year (2004), I can help narrow what to look for in the label history section.

Sources

1. https://www.drugpatentwatch.com/