OBINUTUZUMAB | B125486 | GENENTECH
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Nov. 1, 2013), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Nov. 1, 2025 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 1, 2025 | Passed | 12-year RPE floor |
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 11718680(composition)· AI-discovered, not Purple-Book-listed · relevance 80/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 12 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12391769 | Other | Aug. 14, 2045Active | Discovered |
| 12371510 | Other | Jul. 24, 2045Active | Discovered |
| 12269867 | Other | Apr. 3, 2045Active | Discovered |
| 12195547 | Method-of-use (carveable) | Jan. 9, 2045Active | Discovered |
| 12186392 | Method-of-use (carveable) | Jan. 2, 2045Active | Discovered |
| 12016842 | Method-of-use (carveable) | Jun. 20, 2044Active | Discovered |
| 11913074 | Other | Feb. 22, 2044Active | Discovered |
| 11865175 | Method-of-use (carveable) | Jan. 4, 2044Active | Discovered |
| 11840576 | Method-of-use (carveable) | Dec. 7, 2043Active | Discovered |
| 11802165 | Other | Oct. 26, 2043Active | Discovered |
| 11767342 | Other | Sep. 21, 2043Active | Discovered |
| 11718680 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11718678 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11680110 | Other | Jun. 15, 2043Active | Discovered |
| 11597772 | Method-of-use (carveable) | Mar. 2, 2043Active | 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 195 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.