RAMUCIRUMAB | B125477 | ELI LILLY AND CO
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. 21, 2014), 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. 21, 2026 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | May. 10, 2026 | 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 10562982(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
4 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 1 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11820828 | Other | Nov. 16, 2043Active | Discovered |
| 11471457 | Method-of-use (carveable) | Oct. 13, 2042Active | Discovered |
| 10562982 | Formulation/compound | Feb. 13, 2040Active | Discovered |
| 10238656 | Method-of-use (carveable) | Mar. 21, 2039Active | Discovered |
| 9695241 | Formulation/compound | Jun. 29, 2037Active | Discovered |
| 9670284 | Method-of-use (carveable) | Jun. 1, 2037Active | Discovered |
| 9580499 | Formulation/compound | Feb. 23, 2037Active | Discovered |
| 9526733 | Method-of-use (carveable) | Dec. 22, 2036Active | Discovered |
| 8871201 | Formulation/compound | Oct. 23, 2034Active | Discovered |
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.
9 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.