ECULIZUMAB | B125166 | ALEXION PHARM
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Mar. 16, 2007 — 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 | Feb. 28, 2032 | 5y 7mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of generalized myasthenia gravis (gMG) in pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive", protected through 2032-02-28) 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 generalized myasthenia gravis (gMG) in pediatric patients six years of age and older who are anti-acetylcholine receptor (AChR) antibody positive(label indication #5) | Feb. 28, 2032 | 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 · Feb. 28, 2032
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 12139497(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 22 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12404320 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12240893 | Method-of-use (carveable) | Feb. 27, 2045Active | Discovered |
| 12139497 | Formulation/compound | Nov. 7, 2044Active | Discovered |
| 12128101 | Method-of-use (carveable) | Oct. 24, 2044Active | Discovered |
| 12076319 | Method-of-use (carveable) | Aug. 29, 2044Active | Discovered |
| 12037389 | Method-of-use (carveable) | Jul. 11, 2044Active | Discovered |
| 12018070 | Other | Jun. 20, 2044Active | Discovered |
| 11965884 | Other | Apr. 18, 2044Active | Discovered |
| 11840564 | Method-of-use (carveable) | Dec. 7, 2043Active | Discovered |
| 11807678 | Method-of-use (carveable) | Nov. 2, 2043Active | Discovered |
| 11459382 | Method-of-use (carveable) | Sep. 29, 2042Active | Discovered |
| 11434280 | Formulation/compound | Sep. 1, 2042Active | Discovered |
| 11203634 | Method-of-use (carveable) | Dec. 16, 2041Active | Discovered |
| 11112411 | Other | Sep. 2, 2041Active | Discovered |
| 11104726 | Other | Aug. 26, 2041Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 83 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2024-01-03 | Terminated 2024-09-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.