GUSELKUMAB | B761061 | JANSSEN BIOTECH
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 (Jul. 13, 2017), 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) | Jul. 13, 2029 | 2y 12mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 13, 2029 | 2y 12mo 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 12303483(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
33 formulation/compound (cap skinny entry) · 15 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12404324 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12258393 | Method-of-use (carveable) | Mar. 20, 2045Active | Discovered |
| 12227593 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 12161716 | Formulation/compound | Dec. 5, 2044Active | Discovered |
| 12138295 | Method-of-use (carveable) | Nov. 7, 2044Active | Discovered |
| 12129293 | Formulation/compound | Oct. 24, 2044Active | Discovered |
| 12091452 | Method-of-use (carveable) | Sep. 12, 2044Active | Discovered |
| 12018057 | Formulation/compound | Jun. 20, 2044Active | Discovered |
| 11939361 | Formulation/compound | Mar. 21, 2044Active | Discovered |
| 11883391 | Method-of-use (carveable) | Jan. 25, 2044Active | Discovered |
| 11845808 | Formulation/compound | Dec. 14, 2043Active | Discovered |
| 11780911 | Method-of-use (carveable) | Oct. 5, 2043Active | Discovered |
| 11578124 | Method-of-use (carveable) | Feb. 9, 2043Active | Discovered |
| 11548941 | Method-of-use (carveable) | Jan. 5, 2043Active | Discovered |
Showing 15 of 50 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.
Top 50 of 60 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.