SPESOLIMAB-SBZO | B761244 | BOEHRINGER INGELHEIM PHARMACEUTICALS INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Sep. 1, 2022 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Mar. 18, 2031 | 4y 4mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2031-03-18) advances biosimilar entry from the full-label date to now (no remaining licensure floor).
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of generalized pustular psoriasis (GPP) flares in pediatric patients 12 years of age and older and weighing at least 40 kg, and treatment of GPP in adults and pediatric patients 12 years of age and older and weighing at least 40 kg who are not experiencing a flare(label indication #1) | Mar. 18, 2031 | Open now(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Mar. 18, 2031
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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.