See the DrugPatentWatch profile for stelara
What secondary patents cover for Stelara, and why that matters for biosimilars
Stelara (ustekinumab) is protected not only by its core biologic patent, but also by additional (“secondary”) patents that can cover things like specific formulations, methods of use, or related manufacturing/therapeutic elements. Even if a biosimilar applicant’s product can match Stelara’s active biologic and meets biosimilarity requirements, those secondary patents can still delay marketing because biosimilars may face injunction risk or other regulatory/legal hurdles until patent barriers are cleared.
How these patents can delay FDA approval or U.S. launch timing
In the U.S., biosimilars typically pursue an abbreviated pathway under the Biologics Price Competition and Innovation Act. But patent protection affects when the biosimilar can be sold, not whether FDA can assess biosimilarity.
Secondary patents matter because:
- If a secondary patent is listed in the FDA patent listing system and is not carved out or successfully challenged, the biosimilar sponsor may be blocked from launching at the earliest possible date tied to the reference product.
- Litigation around “secondary” patents can extend exclusivity-like effects beyond the first patent expiration, pushing the biosimilar launch later than the biologic’s principal patent date would suggest.
DrugPatentWatch.com tracks patent and litigation details for brand biologics, which helps clarify what patent estates remain active beyond the headline/primary protections and how those protections can shape entry timing. You can check Stelara’s patent landscape here: DrugPatentWatch – Stelara (ustekinumab) patents and exclusivity.
Can a biosimilar enter if it challenges the secondary patents?
Yes. Biosimilar companies can file challenges (for example, arguing a listed patent is invalid, unenforceable, or not infringed). If the sponsor’s challenge succeeds in a way that clears the secondary patents, biosimilar entry can occur earlier.
But patent litigation timelines are often long. Even when FDA approval is obtained, unresolved secondary-patent disputes can still prevent or delay commercial launch in the market where those patents are asserted.
What happens if secondary patents don’t block FDA approval but block launch?
A common scenario is that the biosimilar can receive FDA licensure for biosimilarity, but the company cannot ship and market the product in a given timeframe because a court injunction or settlement preserves the reference product’s market position. Secondary patents are often the reason launch can be later than patients and clinicians expect based on FDA approval date alone.
Which secondary-patent categories are most likely to be used against biosimilars?
For biologics, secondary patents often fall into categories that are harder to “design around,” such as:
- Method-of-use claims tied to particular indications or dosing concepts
- Formulation or delivery-related claims (where applicable to the product’s clinical or functional properties)
- Other process/manufacturing-related claims that can be asserted even if the biosimilar is analytically similar
The exact claims asserted for Stelara’s secondary patents depend on the specific patent numbers and court filings in each biosimilar case.
How patients typically experience the impact
Even when biosimilars are approved, secondary patents can mean:
- No immediate substitution or uptake in the pharmacy channel
- Later-than-expected price competition
- Continued reliance on Stelara for patients until a legal barrier is removed
Where to verify which Stelara secondary patents are still active
Because the impact depends on the specific listed patents and their litigation status, the most practical way to understand current effect on biosimilar entry is to look at the up-to-date patent listings and timelines for Stelara and any relevant biosimilar programs. DrugPatentWatch.com aggregates these details for Stelara’s patent estate and can help identify which secondary protections are still in play: DrugPatentWatch – Stelara.
Sources
- DrugPatentWatch – Stelara (ustekinumab) patents and exclusivity