VEDOLIZUMAB | B125476 | TAKEDA PHARMS USA
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 (May. 20, 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) | May. 20, 2026 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 20, 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 12286479(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
4 formulation/compound (cap skinny entry) · 8 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12391760 | Method-of-use (carveable) | Aug. 14, 2045Active | Discovered |
| 12286479 | Formulation/compound | Apr. 24, 2045Active | Discovered |
| 12246064 | Method-of-use (carveable) | Mar. 6, 2045Active | Discovered |
| 12171832 | Method-of-use (carveable) | Dec. 19, 2044Active | Discovered |
| 12053526 | Method-of-use (carveable) | Aug. 1, 2044Active | Discovered |
| 11884731 | Method-of-use (carveable) | Jan. 25, 2044Active | Discovered |
| 11760803 | Method-of-use (carveable) | Sep. 14, 2043Active | Discovered |
| 11596688 | Method-of-use (carveable) | Mar. 2, 2043Active | Discovered |
| 11389533 | Method-of-use (carveable) | Jul. 14, 2042Active | Discovered |
| 11180565 | Other | Nov. 18, 2041Active | Discovered |
| 10626166 | Other | Apr. 16, 2040Active | Discovered |
| 9694057 | Formulation/compound | Jun. 29, 2037Active | Discovered |
| 9180189 | Formulation/compound | Nov. 5, 2035Active | Discovered |
| 8673298 | Formulation/compound | Mar. 13, 2034Active | 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.