EMICIZUMAB | B761083 | GENENTECH 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 (Nov. 16, 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) | Nov. 16, 2029 | 3y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 16, 2029 | 3y 4mo 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 12421322(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
38 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421322 | Formulation/compound | Sep. 18, 2045Active | Discovered |
| 12359001 | Other | Jul. 10, 2045Active | Discovered |
| 12297290 | Other | May. 8, 2045Active | Discovered |
| 12240911 | Formulation/compound | Feb. 27, 2045Active | Discovered |
| 12180279 | Other | Dec. 26, 2044Active | Discovered |
| 12168697 | Formulation/compound | Dec. 12, 2044Active | Discovered |
| 12098213 | Formulation/compound | Sep. 19, 2044Active | Discovered |
| 11999801 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11945839 | Other | Mar. 28, 2044Active | Discovered |
| 11787868 | Formulation/compound | Oct. 12, 2043Active | Discovered |
| 11739153 | Formulation/compound | Aug. 24, 2043Active | Discovered |
| 11718678 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11673945 | Formulation/compound | Jun. 8, 2043Active | Discovered |
| 11639394 | Formulation/compound | Apr. 27, 2043Active | Discovered |
| 11634836 | Other | Apr. 20, 2043Active | 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 144 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.