USTEKINUMAB-AUUB | B761285 | AMGEN INC
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Oct. 31, 2023), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Oct. 31, 2035 | 9y 3mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Oct. 31, 2035 | 9y 3mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
First-interchangeable exclusivity (§ 262(k)(6)): Apr. 30, 2025 — blocks other interchangeable designations only. It never gates plain biosimilar licensure and does not enter any entry-LOE above.
Marketing-entry ceiling (litigation risk)
Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.
Latest formulation/compound patent 12365743(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
37 formulation/compound (cap skinny entry) · 9 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12365743 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12281176 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12065488 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 11891435 | Formulation/compound | Feb. 1, 2044Active | Discovered |
| 11365244 | Formulation/compound | Jun. 16, 2042Active | Discovered |
| 11359029 | Formulation/compound | Jun. 9, 2042Active | Discovered |
| 11236155 | Formulation/compound | Jan. 27, 2042Active | Discovered |
| 11198732 | Formulation/compound | Dec. 9, 2041Active | Discovered |
| 11149094 | Formulation/compound | Oct. 14, 2041Active | Discovered |
| 11078267 | Method-of-use (carveable) | Jul. 29, 2041Active | Discovered |
| 11059908 | Formulation/compound | Jul. 8, 2041Active | Discovered |
| 10934328 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10829551 | Formulation/compound | Nov. 5, 2040Active | Discovered |
| 10808033 | Formulation/compound | Oct. 15, 2040Active | Discovered |
| 10597456 | Formulation/compound | Mar. 19, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.
Top 50 of 444 AI-discovered patents by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Alvotech USA Inc. FDA-2024-P-4538 · 15 docket documents 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.