ADUCANUMAB-AVWA | B761178 | BIOGEN 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 (Jun. 7, 2021), 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. 7, 2033 | 6y 10mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 7, 2033 | 6y 10mo 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 11753669(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
16 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 15 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11753669 | Formulation/compound | Sep. 7, 2043Active | Discovered |
| 11697670 | Other | Jul. 6, 2043Active | Discovered |
| 11655289 | Formulation/compound | May. 18, 2043Active | Discovered |
| 11340225 | Method-of-use (carveable) | May. 19, 2042Active | Discovered |
| 10869835 | Formulation/compound | Dec. 17, 2040Active | Discovered |
| 10590454 | Other | Mar. 12, 2040Active | Discovered |
| 10273310 | Formulation/compound | Apr. 25, 2039Active | Discovered |
| 9784751 | Other | Oct. 5, 2037Active | Discovered |
| 9771617 | Other | Sep. 21, 2037Active | Discovered |
| 9752159 | Other | Aug. 31, 2037Active | Discovered |
| 9676849 | Method-of-use (carveable) | Jun. 8, 2037Active | Discovered |
| 9581604 | Other | Feb. 23, 2037Active | Discovered |
| 9562252 | Other | Feb. 2, 2037Active | Discovered |
| 9522174 | Formulation/compound | Dec. 15, 2036Active | Discovered |
| 9409950 | Formulation/compound | Aug. 4, 2036Active | Discovered |
Showing 15 of 34 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.
34 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.