ROZANOLIXIZUMAB-NOLI | B761286 | UCB 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 (Jun. 26, 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) | Jun. 26, 2035 | 8y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 26, 2035 | 8y 11mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
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 12091450(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12281330 | Other | Apr. 17, 2045Active | Discovered |
| 12091450 | Formulation/compound | Sep. 12, 2044Active | Discovered |
| 10799583 | Method-of-use (carveable) | Oct. 8, 2040Active | Discovered |
| 10759844 | Formulation/compound | Aug. 27, 2040Active | Discovered |
| 10421816 | Formulation/compound | Sep. 19, 2039Active | Discovered |
| 10017575 | Formulation/compound | Jul. 5, 2038Active | Discovered |
| 9951365 | Other | Apr. 19, 2038Active | Discovered |
| 9902768 | Formulation/compound | Feb. 22, 2038Active | Discovered |
| 9751930 | Other | Aug. 31, 2037Active | Discovered |
| 9725516 | Other | Aug. 3, 2037Active | Discovered |
| 9550973 | Other | Jan. 19, 2037Active | Discovered |
| 9493558 | Other | Nov. 10, 2036Active | Discovered |
| 9493559 | Other | Nov. 10, 2036Active | Discovered |
| 9476081 | Other | Oct. 20, 2036Active | Discovered |
| 9399671 | Other | Jul. 21, 2036Active | Discovered |
Showing 15 of 42 patents (latest expirations).
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.
42 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.