USTEKINUMAB-TTWE | B761425 | SAMSUNG BIOEPIS CO LTD
Regulatory Exclusivities
| Type | Expiry | Status | Source |
|---|---|---|---|
| 12-Year BPCIA | Jun. 28, 2036 | Active | Computed |
Purple Book Patents
No listed patents in Purple Book.
Estimated Patent LOE
Based on latest discovered patent 12365743(composition) · relevance 85/100
Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.
Approved Biosimilars
Top 50 of 189 AI-discovered patents by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alvotech USA Inc. FDA-2024-P-4538 Alvotech USA Inc. filed this citizen petition under 21 C.F.R. §§ 10.30 and 10.31 and Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refuse to license any biosimilar version of Ustekinumab as interchangeable with the reference product Stelara if manufactured using | 505(q) | 2024-09-26 | Partially Denied | Alvotech USA Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.