DENOSUMAB-NXXP | B761444 | SHANGHAI HENLIUS 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 (Aug. 29, 2025), 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) | Aug. 29, 2037 | 11y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 29, 2037 | 11y 1mo 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 12281176(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
35 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12378521 | Other | Jul. 31, 2045Active | Discovered |
| 12281176 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12241086 | Other | Feb. 27, 2045Active | Discovered |
| 11926672 | Formulation/compound | Mar. 7, 2044Active | Discovered |
| 11891435 | Formulation/compound | Feb. 1, 2044Active | Discovered |
| 11773184 | Formulation/compound | Sep. 28, 2043Active | Discovered |
| 11661462 | Formulation/compound | May. 25, 2043Active | Discovered |
| 11571511 | Other | Feb. 2, 2043Active | Discovered |
| 11505612 | Method-of-use (carveable) | Nov. 17, 2042Active | Discovered |
| 11498964 | Formulation/compound | Nov. 10, 2042Active | Discovered |
| 11486883 | Other | Oct. 27, 2042Active | Discovered |
| 11459370 | Formulation/compound | Sep. 29, 2042Active | Discovered |
| 11427627 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11357916 | Other | Jun. 9, 2042Active | Discovered |
| 11312745 | Other | Apr. 21, 2042Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 255 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-06-25 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.