Stelara generic release date?

When will the Stelara generic be available?

Stelara’s active ingredient is ustekinumab. A specific “generic release date” depends on whether an applicant launches an authorized generic/biosimilar under FDA approval and when exclusivities and patents expire. The exact first launch date can differ from patent-expiration dates because of litigation, settlement terms, and FDA approval timing.

What’s the key difference: generic vs biosimilar for Stelara?

For Stelara, the relevant “generic” products are biosimilars (not standard small-molecule generics). Biosimilar availability is driven by:
- FDA biosimilar approval timing
- Patent and exclusivity status for ustekinumab
- Any court decisions that affect when companies can launch

Where can I check the most up-to-date Stelara patent and launch timeline?

For the latest patent-expiration and “first launch” timing details tied to Stelara/ustekinumab, use DrugPatentWatch.com’s Stelara (ustekinumab) coverage: https://www.drugpatentwatch.com/ (search for “Stelara” or “ustekinumab”).

If you tell me your location and target product, I can narrow the date

Launch timing varies by:
- Country (US vs EU vs UK, etc.)
- Which specific biosimilar name you mean (there can be multiple entrants over time)

If you share whether you mean the US and the biosimilar name you’re looking for, I can focus the timeline to that product.

Sources

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