AFLIBERCEPT-YSZY | B761350 | 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 (May. 20, 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) | May. 20, 2036 | 9y 10mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 20, 2036 | 9y 10mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
First-interchangeable exclusivity (§ 262(k)(6)): Oct. 22, 2026 — blocks other interchangeable designations only. It never gates plain biosimilar licensure and does not enter any entry-LOE above.
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 12338274(formulation)· AI-discovered, not Purple-Book-listed · relevance 93/100. This caps practical skinny-label entry; it does not move the licensure floor above.
33 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12338274 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12331099 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12077570 | Other | Aug. 29, 2044Active | Discovered |
| 12054533 | Other | Aug. 1, 2044Active | Discovered |
| 12049489 | Other | Jul. 25, 2044Active | Discovered |
| 11806398 | Formulation/compound | Nov. 2, 2043Active | Discovered |
| 11753459 | Formulation/compound | Sep. 7, 2043Active | Discovered |
| 11732024 | Formulation/compound | Aug. 17, 2043Active | Discovered |
| 11548932 | Other | Jan. 5, 2043Active | Discovered |
| 11542317 | Formulation/compound | Dec. 29, 2042Active | Discovered |
| 11505593 | Formulation/compound | Nov. 17, 2042Active | Discovered |
| 11459373 | Other | Sep. 29, 2042Active | Discovered |
| 11439683 | Method-of-use (carveable) | Sep. 8, 2042Active | Discovered |
| 11299532 | Other | Apr. 7, 2042Active | Discovered |
| 11180540 | Other | Nov. 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 479 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.