NATALIZUMAB-SZTN | B761322 | SANDOZ 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 (Aug. 24, 2023), 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) | Aug. 24, 2035 | 9y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 24, 2035 | 9y 1mo 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 11965040(composition)· AI-discovered, not Purple-Book-listed · relevance 80/100. This caps practical skinny-label entry; it does not move the licensure floor above.
26 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12234513 | Other | Feb. 20, 2045Active | Discovered |
| 12227807 | Method-of-use (carveable) | Feb. 13, 2045Active | Discovered |
| 12054778 | Other | Aug. 1, 2044Active | Discovered |
| 11965040 | Formulation/compound | Apr. 18, 2044Active | Discovered |
| 11884737 | Method-of-use (carveable) | Jan. 25, 2044Active | Discovered |
| 11447575 | Formulation/compound | Sep. 15, 2042Active | Discovered |
| 11180565 | Other | Nov. 18, 2041Active | Discovered |
| 11091540 | Formulation/compound | Aug. 12, 2041Active | Discovered |
| 10961585 | Other | Mar. 25, 2041Active | Discovered |
| 10941448 | Other | Mar. 4, 2041Active | Discovered |
| 10913984 | Other | Feb. 4, 2041Active | Discovered |
| 10752930 | Other | Aug. 20, 2040Active | Discovered |
| 10563264 | Other | Feb. 13, 2040Active | Discovered |
| 10563163 | Other | Feb. 13, 2040Active | Discovered |
| 10494416 | Formulation/compound | Nov. 28, 2039Active | 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 157 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-09-09 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.