abobotulinumtoxinA | B125274 | IPSEN BIOPHARM LTD
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Apr. 29, 2009 — 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. 29, 2023 | 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 11351232(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 15 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12241098 | Other | Feb. 27, 2045Active | Discovered |
| 11819541 | Method-of-use (carveable) | Nov. 16, 2043Active | Discovered |
| 11530400 | Other | Dec. 15, 2042Active | Discovered |
| 11525130 | Other | Dec. 8, 2042Active | Discovered |
| 11351232 | Formulation/compound | Jun. 2, 2042Active | Discovered |
| 11326155 | Other | May. 5, 2042Active | Discovered |
| 11203748 | Other | Dec. 16, 2041Active | Discovered |
| 11033610 | Method-of-use (carveable) | Jun. 10, 2041Active | Discovered |
| 10857215 | Method-of-use (carveable) | Dec. 3, 2040Active | Discovered |
| 10729751 | Method-of-use (carveable) | Jul. 30, 2040Active | Discovered |
| 10441641 | Method-of-use (carveable) | Oct. 10, 2039Active | Discovered |
| 10406213 | Method-of-use (carveable) | Sep. 5, 2039Active | Discovered |
| 10201594 | Method-of-use (carveable) | Feb. 7, 2039Active | Discovered |
| 10080786 | Formulation/compound | Sep. 20, 2038Active | Discovered |
| 9950042 | Formulation/compound | Apr. 19, 2038Active | Discovered |
Showing 15 of 35 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.
35 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.