PALIFERMIN | B125103 | BIOVITRUM AB
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 15, 2004 — 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 12178873(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
11 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12312381 | Other | May. 22, 2045Active | Discovered |
| 12269843 | Other | Apr. 3, 2045Active | Discovered |
| 12195779 | Other | Jan. 9, 2045Active | Discovered |
| 12178873 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11486883 | Other | Oct. 27, 2042Active | Discovered |
| 11384378 | Other | Jul. 7, 2042Active | Discovered |
| 11384140 | Other | Jul. 7, 2042Active | Discovered |
| 11254963 | Other | Feb. 17, 2042Active | Discovered |
| 11130980 | Other | Sep. 23, 2041Active | Discovered |
| 10822630 | Other | Oct. 29, 2040Active | Discovered |
| 10513723 | Other | Dec. 19, 2039Active | Discovered |
| 10400271 | Other | Aug. 29, 2039Active | Discovered |
| 10166189 | Formulation/compound | Dec. 27, 2038Active | Discovered |
| 10106829 | Other | Oct. 18, 2038Active | Discovered |
Showing 15 of 29 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.
29 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.