RASBURICASE | B103946 | SANOFI SYNTHELABO
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jul. 12, 2002 — 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 | Jul. 12, 2009 | 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 11123369(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
7 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11912741 | Other | Feb. 22, 2044Active | Discovered |
| 11884703 | Other | Jan. 25, 2044Active | Discovered |
| 11685943 | Other | Jun. 22, 2043Active | Discovered |
| 11123369 | Formulation/compound | Sep. 16, 2041Active | Discovered |
| 11098289 | Formulation/compound | Aug. 19, 2041Active | Discovered |
| 11060058 | Other | Jul. 8, 2041Active | Discovered |
| 10968252 | Other | Apr. 1, 2041Active | Discovered |
| 10883087 | Formulation/compound | Dec. 31, 2040Active | Discovered |
| 10815461 | Formulation/compound | Oct. 22, 2040Active | Discovered |
| 10577583 | Other | Feb. 27, 2040Active | Discovered |
| 10568940 | Formulation/compound | Feb. 20, 2040Active | Discovered |
| 10557125 | Other | Feb. 6, 2040Active | Discovered |
| 9657056 | Other | May. 18, 2037Active | Discovered |
| 9650413 | Other | May. 11, 2037Active | Discovered |
| 9650412 | Other | May. 11, 2037Active | Discovered |
Showing 15 of 17 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.
17 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.