SILTUXIMAB | B125496 | RECORDATI RARE DISEASES, 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. 23, 2014), 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. 23, 2026 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 23, 2026 | Passed | 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 12303483(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
8 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12084475 | Other | Sep. 5, 2044Active | Discovered |
| 12065488 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 12016900 | Method-of-use (carveable) | Jun. 20, 2044Active | Discovered |
| 11220531 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 11180549 | Method-of-use (carveable) | Nov. 18, 2041Active | Discovered |
| 11078263 | Formulation/compound | Jul. 29, 2041Active | Discovered |
| 10053513 | Formulation/compound | Aug. 16, 2038Active | Discovered |
| 9631016 | Formulation/compound | Apr. 20, 2037Active | Discovered |
| 9062120 | Formulation/compound | Jun. 18, 2035Active | Discovered |
| 8980626 | Other | Mar. 12, 2035Active | Discovered |
| 7931905 | Formulation/compound | Apr. 21, 2031Active | Discovered |
| 7820799 | Other | Oct. 21, 2030Active | Discovered |
| 7479379 | Other | Jan. 15, 2029Active | Discovered |
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.
14 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.