RISANKIZUMAB-RZAA | B761105 | ABBVIE INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Apr. 23, 2019 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 12365727(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 7 method-of-use (carveable — gate nothing) · 23 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371671 | Other | Jul. 24, 2045Active | Discovered |
| 12371656 | Other | Jul. 24, 2045Active | Discovered |
| 12365727 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12258393 | Method-of-use (carveable) | Mar. 20, 2045Active | Discovered |
| 12157767 | Other | Nov. 28, 2044Active | Discovered |
| 12152072 | Method-of-use (carveable) | Nov. 21, 2044Active | Discovered |
| 12018285 | Other | Jun. 20, 2044Active | Discovered |
| 11952417 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11780911 | Method-of-use (carveable) | Oct. 5, 2043Active | Discovered |
| 11597903 | Other | Mar. 2, 2043Active | Discovered |
| 11572385 | Other | Feb. 2, 2043Active | Discovered |
| 11549108 | Other | Jan. 5, 2043Active | Discovered |
| 11505784 | Other | Nov. 17, 2042Active | Discovered |
| 11396541 | Formulation/compound | Jul. 21, 2042Active | Discovered |
| 11352421 | Method-of-use (carveable) | Jun. 2, 2042Active | Discovered |
Showing 15 of 43 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.
43 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.