SPESOLIMAB-SBZO | B761244 | BOEHRINGER INGELHEIM PHARMACEUTICALS 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 (Sep. 1, 2022), 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) | Sep. 1, 2034 | 8y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 1, 2034 | 8y 1mo 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 12409212(composition)· AI-discovered, not Purple-Book-listed · relevance 68/100. This caps practical skinny-label entry; it does not move the licensure floor above.
21 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 26 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12409212 | Formulation/compound | Sep. 4, 2045Active | Discovered |
| 12371671 | Other | Jul. 24, 2045Active | Discovered |
| 12371651 | Other | Jul. 24, 2045Active | Discovered |
| 12280106 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12195712 | Other | Jan. 9, 2045Active | Discovered |
| 12173083 | Formulation/compound | Dec. 19, 2044Active | Discovered |
| 12171795 | Formulation/compound | Dec. 19, 2044Active | Discovered |
| 12098207 | Method-of-use (carveable) | Sep. 19, 2044Active | Discovered |
| 12060428 | Formulation/compound | Aug. 8, 2044Active | Discovered |
| 12018290 | Other | Jun. 20, 2044Active | Discovered |
| 11976120 | Formulation/compound | May. 2, 2044Active | Discovered |
| 11926664 | Method-of-use (carveable) | Mar. 7, 2044Active | Discovered |
| 11725191 | Other | Aug. 10, 2043Active | Discovered |
| 11572385 | Other | Feb. 2, 2043Active | Discovered |
| 11560549 | Other | Jan. 19, 2043Active | Discovered |
Showing 15 of 50 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.
Top 50 of 112 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.