RAVULIZUMAB-CWVZ | B761108 | ALEXION PHARM
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 21, 2018 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Jun. 7, 2028 | 1y 7mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2028-06-07) advances biosimilar entry from the full-label date to now (no remaining licensure floor).
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| Treatment of pediatric patients one month of age and older with paroxysmal nocturnal hemoglobinuria (PNH)(label indication #1) | Jun. 7, 2028 | Open now(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Jun. 7, 2028
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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.