ZENOCUTUZUMAB-ZBCO | B761352 | MERUS N.V.
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 (Dec. 4, 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) | Dec. 4, 2036 | 10y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 4, 2036 | 10y 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 12018089(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
10 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 11 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12291798 | Other | May. 1, 2045Active | Discovered |
| 12195551 | Method-of-use (carveable) | Jan. 9, 2045Active | Discovered |
| 12123043 | Other | Oct. 17, 2044Active | Discovered |
| 12018089 | Formulation/compound | Jun. 20, 2044Active | Discovered |
| 11952424 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11939394 | Formulation/compound | Mar. 21, 2044Active | Discovered |
| 11926859 | Formulation/compound | Mar. 7, 2044Active | Discovered |
| 11685786 | Formulation/compound | Jun. 22, 2043Active | Discovered |
| 11559049 | Other | Jan. 19, 2043Active | Discovered |
| 11408095 | Other | Aug. 4, 2042Active | Discovered |
| 10966411 | Other | Apr. 1, 2041Active | Discovered |
| 10752929 | Other | Aug. 20, 2040Active | Discovered |
| 10647781 | Other | May. 7, 2040Active | Discovered |
| 10337045 | Formulation/compound | Jun. 27, 2039Active | Discovered |
| 10329596 | Formulation/compound | Jun. 20, 2039Active | Discovered |
Showing 15 of 22 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.
22 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.