LANADELUMAB-FLYO | B761090 | DYAX CORP.
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 (Aug. 23, 2018), 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) | Aug. 23, 2030 | 4y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 23, 2030 | 4y 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 12384854(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
27 formulation/compound (cap skinny entry) · 10 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12442824 | Other | Oct. 9, 2045Active | Discovered |
| 12384854 | Formulation/compound | Aug. 7, 2045Active | Discovered |
| 12110343 | Formulation/compound | Oct. 3, 2044Active | Discovered |
| 12084515 | Formulation/compound | Sep. 5, 2044Active | Discovered |
| 12065505 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 12061206 | Other | Aug. 8, 2044Active | Discovered |
| 11892450 | Other | Feb. 1, 2044Active | Discovered |
| 11884660 | Formulation/compound | Jan. 25, 2044Active | Discovered |
| 11815516 | Other | Nov. 9, 2043Active | Discovered |
| 11754570 | Other | Sep. 7, 2043Active | Discovered |
| 11584735 | Formulation/compound | Feb. 16, 2043Active | Discovered |
| 11505620 | Other | Nov. 17, 2042Active | Discovered |
| 11401346 | Formulation/compound | Jul. 28, 2042Active | Discovered |
| 11372002 | Other | Jun. 23, 2042Active | Discovered |
| 11340237 | Other | May. 19, 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 82 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.