OFATUMUMAB | B125326 | NOVARTIS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Oct. 26, 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 | Jan. 19, 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 12226435(composition)· AI-discovered, not Purple-Book-listed · relevance 72/100. This caps practical skinny-label entry; it does not move the licensure floor above.
21 formulation/compound (cap skinny entry) · 8 method-of-use (carveable — gate nothing) · 21 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371510 | Other | Jul. 24, 2045Active | Discovered |
| 12358945 | Other | Jul. 10, 2045Active | Discovered |
| 12338290 | Method-of-use (carveable) | Jun. 19, 2045Active | Discovered |
| 12226435 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 12161843 | Other | Dec. 5, 2044Active | Discovered |
| 12053491 | Formulation/compound | Aug. 1, 2044Active | Discovered |
| 12054555 | Formulation/compound | Aug. 1, 2044Active | Discovered |
| 11913074 | Other | Feb. 22, 2044Active | Discovered |
| 11865175 | Method-of-use (carveable) | Jan. 4, 2044Active | Discovered |
| 11767370 | Other | Sep. 21, 2043Active | Discovered |
| 11596695 | Formulation/compound | Mar. 2, 2043Active | Discovered |
| 11530238 | Other | Dec. 15, 2042Active | Discovered |
| 11524070 | Other | Dec. 8, 2042Active | Discovered |
| 11512335 | Other | Nov. 24, 2042Active | Discovered |
| 11230718 | Other | Jan. 20, 2042Active | 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 65 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| S.D. Cal. | 2010-03-24 | Terminated 2011-11-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.