ABCIXIMAB | B103575 | CENTOCOR INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 22, 1994 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 10562982(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
8 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 10562982 | Formulation/compound | Feb. 13, 2040Active | Discovered |
| 10112989 | Formulation/compound | Oct. 25, 2038Active | Discovered |
| 10047167 | Other | Aug. 9, 2038Active | Discovered |
| 9381243 | Method-of-use (carveable) | Jun. 30, 2036Active | Discovered |
| 9028816 | Formulation/compound | May. 7, 2035Active | Discovered |
| 8877710 | Method-of-use (carveable) | Oct. 30, 2034Active | Discovered |
| 8871201 | Formulation/compound | Oct. 23, 2034Active | Discovered |
| 8017325 | Other | Sep. 8, 2031Active | Discovered |
| 7498410 | Formulation/compound | Feb. 26, 2029Active | Discovered |
| 7332162 | Formulation/compound | Feb. 14, 2028Active | Discovered |
| 7166612 | Method-of-use (carveable) | Jan. 18, 2027Active | Discovered |
| 7037496 | Formulation/compound | Apr. 27, 2026Expired | Discovered |
| 6652863 | Formulation/compound | Nov. 20, 2023Expired | Discovered |
| 6346517 | Method-of-use (carveable) | Feb. 7, 2022Expired | Discovered |
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.
14 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.