INEBILIZUMAB-CDON | B761142 | VIELA BIO
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 (Jun. 11, 2020), 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) | Jun. 11, 2032 | 5y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 11, 2032 | 5y 11mo 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 12377164(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
23 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 9 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12377164 | Formulation/compound | Jul. 31, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11938192 | Method-of-use (carveable) | Mar. 21, 2044Active | Discovered |
| 11919925 | Other | Feb. 29, 2044Active | Discovered |
| 11912782 | Formulation/compound | Feb. 22, 2044Active | Discovered |
| 11795225 | Formulation/compound | Oct. 19, 2043Active | Discovered |
| 11701430 | Formulation/compound | Jul. 13, 2043Active | Discovered |
| 11690918 | Formulation/compound | Jun. 29, 2043Active | Discovered |
| 11484606 | Formulation/compound | Oct. 27, 2042Active | Discovered |
| 11414477 | Other | Aug. 11, 2042Active | Discovered |
| 10799596 | Formulation/compound | Oct. 8, 2040Active | Discovered |
| 10780096 | Formulation/compound | Sep. 17, 2040Active | Discovered |
| 10744204 | Formulation/compound | Aug. 13, 2040Active | Discovered |
| 10618952 | Other | Apr. 9, 2040Active | Discovered |
| 10576164 | Formulation/compound | Feb. 27, 2040Active | Discovered |
Showing 15 of 34 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.
34 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.