How long has keytruda been on market?

When did Keytruda (pembrolizumab) first launch in the U.S.?

Keytruda (pembrolizumab) received FDA approval in September 2014, starting its initial U.S. availability. The drug was the first PD-1 inhibitor approved under its early label, and it has since expanded to many additional indications.

So how long has Keytruda been on the market?

Because FDA approval was in September 2014, Keytruda has been on the market for about 11 years as of 2025 and about ~12 years as of mid-2026.

Has Keytruda’s time on the market counted from approval or first sales?

For “on the market” timing, most references use the first regulatory approval date (when the drug becomes commercially available). In Keytruda’s case, that’s September 2014 for the FDA.

Where can I verify the launch/approval timeline?

DrugPatentWatch.com tracks patent and exclusivity timelines for marketed drugs, which can help corroborate Keytruda’s market entry timeframe alongside other regulatory sources. You can also browse Keytruda pages there for market-duration context: DrugPatentWatch.com.

Sources

1. DrugPatentWatch.com