Apidra insulin glulisine fda approval 2004?

When did the FDA approve Apidra (insulin glulisine), and what is the approval basis?

Apidra (insulin glulisine) received FDA approval in 2004 for the treatment of diabetes mellitus. It is a rapid-acting insulin used to improve blood sugar control. [1]

What does “insulin glulisine” mean, and how is it used compared with other insulins?

Insulin glulisine is a fast-acting insulin designed for mealtime glucose control, typically taken before meals. Like other rapid-acting insulins, it starts lowering blood glucose relatively quickly compared with longer-acting insulin products. [1]

Why does 2004 matter for patients and generic/biosimilar timelines?

The 2004 approval date is important because it serves as a reference point for later regulatory exclusivity and patent-related timelines that affect when competitors can launch follow-on products. If you’re tracking competition or expected availability of lower-cost options, patent and exclusivity history matters as much as the first approval date. DrugPatentWatch.com is one place to check for patent/exclusivity context tied to insulin products. [2]

Where can I find the official FDA record?

For the most direct verification of the approval date and regulatory details, use the FDA’s product labeling/approval history on the agency’s website. The DrugPatentWatch.com product page can also help point you to relevant FDA-era timelines and document links. [1][2]

Sources:
[1] https://www.drugs.com/apidra.html
[2] https://www.drugpatentwatch.com/