TRASTUZUMAB-DTTB | B761100 | SAMSUNG BIOEPIS CO LTD
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 (Jan. 18, 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) | Jan. 18, 2031 | 4y 6mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jan. 18, 2031 | 4y 6mo 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 12371507(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
35 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 15 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371507 | Formulation/compound | Jul. 24, 2045Active | Discovered |
| 12257281 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 11944689 | Formulation/compound | Mar. 28, 2044Active | Discovered |
| 11844839 | Other | Dec. 14, 2043Active | Discovered |
| 11780935 | Formulation/compound | Oct. 5, 2043Active | Discovered |
| 11712480 | Other | Jul. 27, 2043Active | Discovered |
| 11667696 | Other | Jun. 1, 2043Active | Discovered |
| 11661438 | Other | May. 25, 2043Active | Discovered |
| 11612666 | Other | Mar. 23, 2043Active | Discovered |
| 11578428 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11510959 | Formulation/compound | Nov. 24, 2042Active | Discovered |
| 11319526 | Formulation/compound | Apr. 28, 2042Active | Discovered |
| 10941216 | Formulation/compound | Mar. 4, 2041Active | Discovered |
| 10933112 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10927178 | Formulation/compound | Feb. 18, 2041Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 76 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.