DONANEMAB-AZBT | B761248 | ELI LILLY 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 (Jul. 2, 2024), 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) | Jul. 2, 2036 | 9y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 2, 2036 | 9y 11mo 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 12275960(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
30 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12329939 | Other | Jun. 12, 2045Active | Discovered |
| 12275960 | Formulation/compound | Apr. 10, 2045Active | Discovered |
| 11976136 | Formulation/compound | May. 2, 2044Active | Discovered |
| 11957882 | Other | Apr. 11, 2044Active | Discovered |
| 11878154 | Other | Jan. 18, 2044Active | Discovered |
| 11850402 | Other | Dec. 21, 2043Active | Discovered |
| 11820828 | Other | Nov. 16, 2043Active | Discovered |
| 11078261 | Formulation/compound | Jul. 29, 2041Active | Discovered |
| 11066460 | Other | Jul. 15, 2041Active | Discovered |
| 11045601 | Other | Jun. 24, 2041Active | Discovered |
| 10987471 | Other | Apr. 22, 2041Active | Discovered |
| 10913793 | Formulation/compound | Feb. 4, 2041Active | Discovered |
| 10898652 | Other | Jan. 21, 2041Active | Discovered |
| 10864326 | Other | Dec. 10, 2040Active | Discovered |
| 10774156 | Formulation/compound | Sep. 10, 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 71 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.