ALDESLEUKIN | B103293 | CHIRON
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 5, 1992 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Jan. 9, 2005 | Passed | no live block |
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 12247059(formulation)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 7 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12403181 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12247059 | Formulation/compound | Mar. 6, 2045Active | Discovered |
| 12240884 | Method-of-use (carveable) | Feb. 27, 2045Active | Discovered |
| 12006354 | Formulation/compound | Jun. 6, 2044Active | Discovered |
| 11930837 | Method-of-use (carveable) | Mar. 14, 2044Active | Discovered |
| 11919946 | Formulation/compound | Feb. 29, 2044Active | Discovered |
| 11851666 | Other | Dec. 21, 2043Active | Discovered |
| 11524070 | Other | Dec. 8, 2042Active | Discovered |
| 11512335 | Other | Nov. 24, 2042Active | Discovered |
| 11384131 | Formulation/compound | Jul. 7, 2042Active | Discovered |
| 11122825 | Formulation/compound | Sep. 16, 2041Active | Discovered |
| 11110150 | Formulation/compound | Sep. 2, 2041Active | Discovered |
| 11091525 | Formulation/compound | Aug. 12, 2041Active | Discovered |
| 11028177 | Formulation/compound | Jun. 3, 2041Active | Discovered |
| 10960079 | Formulation/compound | Mar. 25, 2041Active | Discovered |
Showing 15 of 37 patents (latest expirations).
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.
37 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.