FAM-TRASTUZUMAB DERUXTECAN-NXKI | B761139 | DAIICHI SANKYO
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. 20, 2019), 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. 20, 2031 | 5y 5mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 20, 2031 | 5y 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 12377164(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
39 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12377164 | Formulation/compound | Jul. 31, 2045Active | Discovered |
| 12337038 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12209099 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11938192 | Method-of-use (carveable) | Mar. 21, 2044Active | Discovered |
| 11919925 | Other | Feb. 29, 2044Active | Discovered |
| 11912782 | Formulation/compound | Feb. 22, 2044Active | Discovered |
| 11779650 | Formulation/compound | Oct. 5, 2043Active | Discovered |
| 11759526 | Other | Sep. 14, 2043Active | Discovered |
| 11701430 | Formulation/compound | Jul. 13, 2043Active | Discovered |
| 11690918 | Formulation/compound | Jun. 29, 2043Active | Discovered |
| 11612665 | Formulation/compound | Mar. 23, 2043Active | Discovered |
| 11484606 | Formulation/compound | Oct. 27, 2042Active | Discovered |
| 11414477 | Other | Aug. 11, 2042Active | Discovered |
| 11370801 | Formulation/compound | Jun. 23, 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 55 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.