VEDOLIZUMAB | B761133 | TAKEDA PHARMS USA
No 12-year reference-product exclusivity is listed in the Purple Book.
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.
8 formulation/compound (cap skinny entry) · 8 method-of-use (carveable — gate nothing) · 3 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 | Formulation/compound | Aug. 1, 2044Active | Discovered |
| 11884731 | Method-of-use (carveable) | Jan. 25, 2044Active | Discovered |
| 11760803 | Method-of-use (carveable) | Sep. 14, 2043Active | Discovered |
| 11598024 | Formulation/compound | Mar. 2, 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 |
| 10655099 | Other | May. 14, 2040Active | Discovered |
| 10324088 | Method-of-use (carveable) | Jun. 13, 2039Active | Discovered |
| 10238720 | Formulation/compound | Mar. 21, 2039Active | Discovered |
| 10138461 | Other | Nov. 22, 2038Active | Discovered |
Showing 15 of 19 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.
19 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.