ANSUVIMAB-ZYKL | B761172 | RIDGEBACK BIOTHERAPEUTICS
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. 21, 2020), 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. 21, 2032 | 6y 5mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 21, 2032 | 6y 5mo 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 10882898(composition)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
15 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12102677 | Method-of-use (carveable) | Sep. 26, 2044Active | Discovered |
| 11833214 | Other | Nov. 30, 2043Active | Discovered |
| 10882898 | Formulation/compound | Dec. 31, 2040Active | Discovered |
| 9872922 | Formulation/compound | Jan. 18, 2038Active | Discovered |
| 9707300 | Formulation/compound | Jul. 13, 2037Active | Discovered |
| 9598667 | Other | Mar. 16, 2037Active | Discovered |
| 9592293 | Formulation/compound | Mar. 9, 2037Active | Discovered |
| 9550986 | Method-of-use (carveable) | Jan. 19, 2037Active | Discovered |
| 9458244 | Formulation/compound | Sep. 29, 2036Active | Discovered |
| 9266950 | Other | Feb. 18, 2036Active | Discovered |
| 8889669 | Formulation/compound | Nov. 13, 2034Active | Discovered |
| 8877194 | Formulation/compound | Oct. 30, 2034Active | Discovered |
| 8680246 | Formulation/compound | Mar. 20, 2034Active | Discovered |
| 8633139 | Other | Jan. 16, 2034Active | Discovered |
| 8236319 | Formulation/compound | Aug. 2, 2032Active | Discovered |
Showing 15 of 21 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.
21 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.