ROMOSOZUMAB-AQQG | B761062 | AMGEN INC
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 (Apr. 9, 2019), 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) | Apr. 9, 2031 | 4y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 9, 2031 | 4y 8mo 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 12297260(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
29 formulation/compound (cap skinny entry) · 11 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421304 | Method-of-use (carveable) | Sep. 18, 2045Active | Discovered |
| 12325737 | Other | Jun. 5, 2045Active | Discovered |
| 12297260 | Formulation/compound | May. 8, 2045Active | Discovered |
| 12257343 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12178873 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12103979 | Formulation/compound | Sep. 26, 2044Active | Discovered |
| 11993663 | Formulation/compound | May. 23, 2044Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11198732 | Formulation/compound | Dec. 9, 2041Active | Discovered |
| 11091537 | Method-of-use (carveable) | Aug. 12, 2041Active | Discovered |
| 11040102 | Formulation/compound | Jun. 17, 2041Active | Discovered |
| 10829551 | Formulation/compound | Nov. 5, 2040Active | Discovered |
| 10822630 | Other | Oct. 29, 2040Active | Discovered |
| 10800839 | Formulation/compound | Oct. 8, 2040Active | Discovered |
| 10799583 | Method-of-use (carveable) | Oct. 8, 2040Active | 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 85 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.