DENOSUMAB | B125320 | AMGEN
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 (Jun. 1, 2010), 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) | Jun. 1, 2022 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 1, 2022 | Passed | 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 12318447(formulation)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
78 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12390583 | Other | Aug. 14, 2045Active | Discovered |
| 12318447 | Formulation/compound | May. 29, 2045Active | Discovered |
| 12290666 | Other | May. 1, 2045Active | Discovered |
| 12257343 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12178873 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12103979 | Formulation/compound | Sep. 26, 2044Active | Discovered |
| 11944798 | Other | Mar. 28, 2044Active | Discovered |
| 11904143 | Other | Feb. 15, 2044Active | Discovered |
| 11873343 | Formulation/compound | Jan. 11, 2044Active | Discovered |
| 11827692 | Other | Nov. 23, 2043Active | Discovered |
| 11738138 | Other | Aug. 24, 2043Active | Discovered |
| 11447547 | Other | Sep. 15, 2042Active | Discovered |
| 11389588 | Other | Jul. 14, 2042Active | Discovered |
| 11198732 | Formulation/compound | Dec. 9, 2041Active | Discovered |
Showing 15 of 99 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 102 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2025-11-14 | Active | — | |
| D.N.J. | 2025-11-06 | Active | — | |
| D.N.J. | 2025-11-06 | Active | — | |
| D.N.J. | 2025-07-16 | Terminated 2026-01-22 | — | |
| D. Mass. | 2025-06-30 | Terminated 2025-07-15 | — | |
| D.N.J. | 2025-06-25 | Active | — | |
| D.N.J. | 2025-06-25 | Terminated 2025-11-24 | — | |
| D.N.J. | 2025-02-07 | Terminated 2025-03-11 | — | |
| E.D.N.C. | 2024-11-13 | Terminated 2025-02-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Public Citizen Health Research Group FDA-2019-P-1818 · 7 docket documents Public Citizen Health Research Group filed this petition on April 16, 2019, under Section 352 of the Federal Food, Drug, and Cosmetic Act requesting that the FDA add a boxed warning to Prolia (denosumab) labeling describing the risk of vertebral fractures upon treatment discontinuation and implement | Other | 2019-04-17 | Partially Denied | Public Citizen Health Research Group |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.