CERTOLIZUMAB PEGOL | B125160 | UCB INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Apr. 22, 2008 — 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 11578428(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
16 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11844839 | Other | Dec. 14, 2043Active | Discovered |
| 11779643 | Other | Oct. 5, 2043Active | Discovered |
| 11661438 | Other | May. 25, 2043Active | Discovered |
| 11578428 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11339214 | Other | May. 19, 2042Active | Discovered |
| 10941216 | Formulation/compound | Mar. 4, 2041Active | Discovered |
| 10918737 | Method-of-use (carveable) | Feb. 11, 2041Active | Discovered |
| 10759844 | Formulation/compound | Aug. 27, 2040Active | Discovered |
| 10647756 | Formulation/compound | May. 7, 2040Active | Discovered |
| 10443035 | Other | Oct. 10, 2039Active | Discovered |
| 10188600 | Formulation/compound | Jan. 24, 2039Active | Discovered |
| 10189897 | Other | Jan. 24, 2039Active | Discovered |
| 9951365 | Other | Apr. 19, 2038Active | Discovered |
| 9902768 | Formulation/compound | Feb. 22, 2038Active | Discovered |
| 9822143 | Other | Nov. 16, 2037Active | Discovered |
Showing 15 of 36 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.
36 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.