RAVULIZUMAB-CWVZ | B761108 | ALEXION PHARM
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, 2018), 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, 2030 | 4y 5mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 21, 2030 | 4y 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 12065459(composition)· AI-discovered, not Purple-Book-listed · relevance 62/100. This caps practical skinny-label entry; it does not move the licensure floor above.
21 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12404320 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12312394 | Other | May. 22, 2045Active | Discovered |
| 12240893 | Method-of-use (carveable) | Feb. 27, 2045Active | Discovered |
| 12128101 | Method-of-use (carveable) | Oct. 24, 2044Active | Discovered |
| 12076319 | Method-of-use (carveable) | Aug. 29, 2044Active | Discovered |
| 12065459 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 12012448 | Formulation/compound | Jun. 13, 2044Active | Discovered |
| 11965884 | Other | Apr. 18, 2044Active | Discovered |
| 11919925 | Other | Feb. 29, 2044Active | Discovered |
| 11414477 | Other | Aug. 11, 2042Active | Discovered |
| 11365241 | Formulation/compound | Jun. 16, 2042Active | Discovered |
| 11198725 | Formulation/compound | Dec. 9, 2041Active | Discovered |
| 11112411 | Other | Sep. 2, 2041Active | Discovered |
| 10744204 | Formulation/compound | Aug. 13, 2040Active | Discovered |
| 10689409 | Formulation/compound | Jun. 18, 2040Active | Discovered |
Showing 15 of 39 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.
39 AI-discovered patents, sorted by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-11-12 | Terminated 2022-05-04 | — | |
| D. Del. | 2018-11-15 | Terminated 2022-03-17 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.