BASILIXIMAB | B103764 | NOVARTIS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 12, 1998 — 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 | May. 12, 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 11596695(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371510 | Other | Jul. 24, 2045Active | Discovered |
| 12098178 | Method-of-use (carveable) | Sep. 19, 2044Active | Discovered |
| 11851666 | Other | Dec. 21, 2043Active | Discovered |
| 11780927 | Method-of-use (carveable) | Oct. 5, 2043Active | Discovered |
| 11767370 | Other | Sep. 21, 2043Active | Discovered |
| 11596695 | Formulation/compound | Mar. 2, 2043Active | Discovered |
| 11524070 | Other | Dec. 8, 2042Active | Discovered |
| 11384131 | Formulation/compound | Jul. 7, 2042Active | Discovered |
| 11203631 | Other | Dec. 16, 2041Active | Discovered |
| 11046757 | Formulation/compound | Jun. 24, 2041Active | Discovered |
| 10899841 | Formulation/compound | Jan. 21, 2041Active | Discovered |
| 10781268 | Formulation/compound | Sep. 17, 2040Active | Discovered |
| 10370456 | Other | Aug. 1, 2039Active | Discovered |
| 10117953 | Formulation/compound | Nov. 1, 2038Active | Discovered |
| 9751951 | Formulation/compound | Aug. 31, 2037Active | Discovered |
Showing 15 of 38 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.
38 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.