OMALIZUMAB | B103976 | GENENTECH
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 20, 2003 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 12030959. This caps practical skinny-label entry; it does not move the licensure floor above.
8 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 0 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12030959 | Formulation/compound | Jul. 20, 2043Active | Purple Book |
| 10017732 | Formulation/compound | Mar. 14, 2034Active | Purple Book |
| 10676710 | Formulation/compound | Mar. 14, 2034Active | Purple Book |
| 10829732 | Formulation/compound | Mar. 14, 2034Active | Purple Book |
| 11078294 | Formulation/compound | Jul. 8, 2028Active | Purple Book |
| 11987637 | Formulation/compound | Jul. 8, 2028Active | Purple Book |
| 8574869 | Formulation/compound | Jul. 8, 2028Active | Purple Book |
| 10034940 | Formulation/compound | Nov. 4, 2025Expired | Purple Book |
Approved Biosimilars
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.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2026-00260 | 12030959 | IPR | Amneal Pharmaceuticals, Inc. et al. | Pending | 2026-05-26 | — |
No patent or exclusivity listings for this strength.