OnabotulinumtoxinA | B103000 | ALLERGAN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 9, 1991 — 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 | Jun. 20, 2026 | 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 12171816(formulation)· AI-discovered, not Purple-Book-listed · relevance 95/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 13 method-of-use (carveable — gate nothing) · 15 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12241098 | Other | Feb. 27, 2045Active | Discovered |
| 12171816 | Formulation/compound | Dec. 19, 2044Active | Discovered |
| 11819541 | Method-of-use (carveable) | Nov. 16, 2043Active | Discovered |
| 11530400 | Other | Dec. 15, 2042Active | Discovered |
| 11525130 | Other | Dec. 8, 2042Active | Discovered |
| 11286473 | Formulation/compound | Mar. 24, 2042Active | Discovered |
| 11203748 | Other | Dec. 16, 2041Active | Discovered |
| 11124786 | Other | Sep. 16, 2041Active | Discovered |
| 11104891 | Formulation/compound | Aug. 26, 2041Active | Discovered |
| 11077174 | Method-of-use (carveable) | Jul. 29, 2041Active | Discovered |
| 10900967 | Other | Jan. 21, 2041Active | Discovered |
| 10874722 | Method-of-use (carveable) | Dec. 24, 2040Active | Discovered |
| 10844362 | Formulation/compound | Nov. 19, 2040Active | Discovered |
| 10703806 | Other | Jul. 2, 2040Active | Discovered |
| 10527620 | Other | Jan. 2, 2040Active | Discovered |
Showing 15 of 50 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.
Top 50 of 192 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Allergan, Inc. v. Revance Therapeutics, Inc. et al 5 patentsbotulinum neurotoxin type A (BoNT/A), OnabotulinumtoxinA | D. Del. | 2021-10-01 | Active | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.