RANIBIZUMAB-NUNA | B761202 | 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 (Sep. 17, 2021), 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) | Sep. 17, 2033 | 7y 2mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 17, 2033 | 7y 2mo 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 12098213(composition)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
31 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12173080 | Other | Dec. 19, 2044Active | Discovered |
| 12098213 | Formulation/compound | Sep. 19, 2044Active | Discovered |
| 11976127 | Other | May. 2, 2044Active | Discovered |
| 11865177 | Formulation/compound | Jan. 4, 2044Active | Discovered |
| 11807855 | Other | Nov. 2, 2043Active | Discovered |
| 11680110 | Other | Jun. 15, 2043Active | Discovered |
| 11634497 | Formulation/compound | Apr. 20, 2043Active | Discovered |
| 11440971 | Formulation/compound | Sep. 8, 2042Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11078243 | Formulation/compound | Jul. 29, 2041Active | Discovered |
| 10745731 | Other | Aug. 13, 2040Active | Discovered |
| 10696721 | Formulation/compound | Jun. 25, 2040Active | Discovered |
| 10590186 | Other | Mar. 12, 2040Active | Discovered |
| 10525137 | Formulation/compound | Jan. 2, 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.
Top 50 of 221 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.