ADO-TRASTUZUMAB EMTANSINE | B125427 | GENENTECH
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 (Feb. 22, 2013), 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) | Feb. 22, 2025 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Feb. 22, 2025 | Passed | 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 12427193(formulation)· AI-discovered, not Purple-Book-listed · relevance 96/100. This caps practical skinny-label entry; it does not move the licensure floor above.
41 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12427193 | Formulation/compound | Sep. 25, 2045Active | Discovered |
| 12331134 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12281153 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12173080 | Other | Dec. 19, 2044Active | Discovered |
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12090211 | Formulation/compound | Sep. 12, 2044Active | Discovered |
| 11873330 | Formulation/compound | Jan. 11, 2044Active | Discovered |
| 11860156 | Other | Dec. 28, 2043Active | Discovered |
| 11692043 | Formulation/compound | Jun. 29, 2043Active | Discovered |
| 11576981 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11530275 | Formulation/compound | Dec. 15, 2042Active | Discovered |
| 11406715 | Method-of-use (carveable) | Aug. 4, 2042Active | Discovered |
| 11370838 | Other | Jun. 23, 2042Active | Discovered |
| 11104673 | Formulation/compound | Aug. 26, 2041Active | Discovered |
| 11090322 | Formulation/compound | Aug. 12, 2041Active | 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 185 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| N.D. Cal. | 2015-03-17 | Terminated 2017-08-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.