TRALOKINUMAB | B761180 | LEO PHARMA AS
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 (Dec. 27, 2021), 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) | Dec. 27, 2033 | 7y 5mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 27, 2033 | 7y 5mo 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 12070502(formulation)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 7 method-of-use (carveable — gate nothing) · 24 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12436152 | Method-of-use (carveable) | Oct. 2, 2045Active | Discovered |
| 12371487 | Other | Jul. 24, 2045Active | Discovered |
| 12320790 | Other | May. 29, 2045Active | Discovered |
| 12187788 | Method-of-use (carveable) | Jan. 2, 2045Active | Discovered |
| 12187792 | Method-of-use (carveable) | Jan. 2, 2045Active | Discovered |
| 12174173 | Other | Dec. 19, 2044Active | Discovered |
| 12070502 | Formulation/compound | Aug. 22, 2044Active | Discovered |
| 12055551 | Other | Aug. 1, 2044Active | Discovered |
| 12042538 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 12036280 | Formulation/compound | Jul. 11, 2044Active | Discovered |
| 11964016 | Method-of-use (carveable) | Apr. 18, 2044Active | Discovered |
| 11885811 | Other | Jan. 25, 2044Active | Discovered |
| 11713922 | Formulation/compound | Jul. 27, 2043Active | Discovered |
| 11560550 | Other | Jan. 19, 2043Active | Discovered |
| 11530277 | Other | Dec. 15, 2042Active | 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 93 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.