TEPROTUMUMAB-TRBW | B761143 | HORIZON THERAPEUTICS IRELAND
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 (Jan. 21, 2020), 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) | Jan. 21, 2032 | 5y 6mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jan. 21, 2032 | 5y 6mo 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.
0 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 0 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358993 | Method-of-use (carveable) | Jul. 10, 2045Active | Discovered |
| 12286481 | Method-of-use (carveable) | Apr. 24, 2045Active | Discovered |
| 12209130 | Method-of-use (carveable) | Jan. 23, 2045Active | Discovered |
| 11208489 | Method-of-use (carveable) | Dec. 23, 2041Active | Discovered |
| 11208490 | Method-of-use (carveable) | Dec. 23, 2041Active | Discovered |
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.
5 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.