TRASTUZUMAB-STRF | B761346 | ACCORD BIOPHARMA INC.
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 (Apr. 25, 2024), 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) | Apr. 25, 2036 | 9y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 25, 2036 | 9y 9mo 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 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.
32 formulation/compound (cap skinny entry) · 16 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12427193 | Formulation/compound | Sep. 25, 2045Active | Discovered |
| 12128103 | Method-of-use (carveable) | Oct. 24, 2044Active | Discovered |
| 12110341 | Formulation/compound | Oct. 3, 2044Active | Discovered |
| 11992529 | Method-of-use (carveable) | May. 23, 2044Active | Discovered |
| 11787873 | Formulation/compound | Oct. 12, 2043Active | Discovered |
| 11655305 | Method-of-use (carveable) | May. 18, 2043Active | Discovered |
| 11638756 | Method-of-use (carveable) | Apr. 27, 2043Active | Discovered |
| 11597776 | Formulation/compound | Mar. 2, 2043Active | Discovered |
| 11414498 | Formulation/compound | Aug. 11, 2042Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11077189 | Method-of-use (carveable) | Jul. 29, 2041Active | Discovered |
| 10898570 | Method-of-use (carveable) | Jan. 21, 2041Active | Discovered |
| 10689457 | Method-of-use (carveable) | Jun. 18, 2040Active | Discovered |
| 10584178 | Formulation/compound | Mar. 5, 2040Active | Discovered |
| 10556966 | Formulation/compound | Feb. 6, 2040Active | 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.
0 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.