FAM-TRASTUZUMAB DERUXTECAN-NXKI | B761139 | DAIICHI SANKYO
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 20, 2019 — 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 | Jan. 15, 2028 | 1y 2mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2028-01-15) 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 adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen(label indication #9) | Jan. 15, 2028 | 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 · Jan. 15, 2028
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 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.