PEGASPARGASE | B103411 | SIGMA TAU
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 1, 1994 — 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. 1, 2001 | Passed | no live block |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
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 11739152(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
10 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11739152 | Formulation/compound | Aug. 24, 2043Active | Discovered |
| 10413600 | Method-of-use (carveable) | Sep. 12, 2039Active | Discovered |
| 10238720 | Formulation/compound | Mar. 21, 2039Active | Discovered |
| 9547016 | Method-of-use (carveable) | Jan. 12, 2037Active | Discovered |
| 9327034 | Formulation/compound | Apr. 28, 2036Active | Discovered |
| 8299089 | Formulation/compound | Oct. 25, 2032Active | Discovered |
| 8268318 | Formulation/compound | Sep. 13, 2032Active | Discovered |
| 7868131 | Other | Jan. 6, 2031Active | Discovered |
| 7833742 | Formulation/compound | Nov. 11, 2030Active | Discovered |
| 7601798 | Other | Oct. 8, 2029Active | Discovered |
| 7413738 | Formulation/compound | Aug. 14, 2028Active | Discovered |
| 7365127 | Other | Apr. 24, 2028Active | Discovered |
| 7332164 | Formulation/compound | Feb. 14, 2028Active | Discovered |
| 7301003 | Other | Nov. 22, 2027Active | Discovered |
| 7087229 | Formulation/compound | Aug. 3, 2026Active | Discovered |
Showing 15 of 16 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.
16 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.