DARATUMUMAB AND HYALURONIDASE-FIHJ | B761145 | 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 (May. 1, 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) | May. 1, 2032 | 5y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 1, 2032 | 5y 9mo 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 12365743(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12365743 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12240790 | Other | Feb. 27, 2045Active | Discovered |
| 12227593 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 12173076 | Formulation/compound | Dec. 19, 2044Active | Discovered |
| 12084475 | Other | Sep. 5, 2044Active | Discovered |
| 12049512 | Formulation/compound | Jul. 25, 2044Active | Discovered |
| 11918791 | Other | Feb. 29, 2044Active | Discovered |
| 11795214 | Formulation/compound | Oct. 19, 2043Active | Discovered |
| 11220531 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 11155640 | Formulation/compound | Oct. 21, 2041Active | Discovered |
| 11149094 | Formulation/compound | Oct. 14, 2041Active | Discovered |
| 11078263 | Formulation/compound | Jul. 29, 2041Active | Discovered |
| 10906991 | Formulation/compound | Jan. 28, 2041Active | Discovered |
| 10759867 | Formulation/compound | Aug. 27, 2040Active | Discovered |
Showing 15 of 35 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.
35 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.