AVELUMAB | B761049 | EMD SERONO 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 (Mar. 23, 2017), 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) | Mar. 23, 2029 | 2y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 23, 2029 | 2y 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 12384852(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 17 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12429485 | Other | Sep. 25, 2045Active | Discovered |
| 12384852 | Formulation/compound | Aug. 7, 2045Active | Discovered |
| 12338283 | Method-of-use (carveable) | Jun. 19, 2045Active | Discovered |
| 12281339 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12186278 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 12144839 | Method-of-use (carveable) | Nov. 14, 2044Active | Discovered |
| 12016900 | Method-of-use (carveable) | Jun. 20, 2044Active | Discovered |
| 11977075 | Other | May. 2, 2044Active | Discovered |
| 11951166 | Method-of-use (carveable) | Apr. 4, 2044Active | Discovered |
| 11725056 | Method-of-use (carveable) | Aug. 10, 2043Active | Discovered |
| 11684640 | Method-of-use (carveable) | Jun. 22, 2043Active | Discovered |
| 11685782 | Method-of-use (carveable) | Jun. 22, 2043Active | Discovered |
| 11655297 | Formulation/compound | May. 18, 2043Active | Discovered |
| 11566066 | Formulation/compound | Jan. 26, 2043Active | Discovered |
| 11524063 | Formulation/compound | Dec. 8, 2042Active | 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 90 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2017-07-26 | Terminated 2019-02-12 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.