INSULIN ASPART-SZJJ | B761325 | SANOFI-AVENTIS U.S. LLC
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 (Feb. 14, 2025), 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) | Feb. 14, 2037 | 10y 7mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Feb. 14, 2037 | 10y 7mo 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 12286475(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
28 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12286475 | Formulation/compound | Apr. 24, 2045Active | Discovered |
| 12227560 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 11787837 | Other | Oct. 12, 2043Active | Discovered |
| 11396534 | Formulation/compound | Jul. 21, 2042Active | Discovered |
| 11318191 | Formulation/compound | Apr. 28, 2042Active | Discovered |
| 11274280 | Formulation/compound | Mar. 10, 2042Active | Discovered |
| 11242382 | Formulation/compound | Feb. 3, 2042Active | Discovered |
| 11236126 | Other | Jan. 27, 2042Active | Discovered |
| 10919949 | Formulation/compound | Feb. 11, 2041Active | Discovered |
| 10793622 | Other | Oct. 1, 2040Active | Discovered |
| 10308917 | Formulation/compound | May. 30, 2039Active | Discovered |
| 9592289 | Formulation/compound | Mar. 9, 2037Active | Discovered |
| 9474790 | Formulation/compound | Oct. 20, 2036Active | Discovered |
| 9441029 | Formulation/compound | Sep. 8, 2036Active | Discovered |
| 9340514 | Formulation/compound | May. 12, 2036Active | 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.