OCRELIZUMAB | B761053 | GENENTECH INC
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 (Mar. 28, 2017), 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) | Mar. 28, 2029 | 2y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 28, 2029 | 2y 8mo remaining | 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 12209121(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
18 formulation/compound (cap skinny entry) · 8 method-of-use (carveable — gate nothing) · 24 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12440525 | Method-of-use (carveable) | Oct. 9, 2045Active | Discovered |
| 12391769 | Other | Aug. 14, 2045Active | Discovered |
| 12209121 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12186392 | Method-of-use (carveable) | Jan. 2, 2045Active | Discovered |
| 12173080 | Other | Dec. 19, 2044Active | Discovered |
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12076353 | Method-of-use (carveable) | Aug. 29, 2044Active | Discovered |
| 12030952 | Formulation/compound | Jul. 4, 2044Active | Discovered |
| 11987638 | Other | May. 16, 2044Active | Discovered |
| 11976127 | Other | May. 2, 2044Active | Discovered |
| 11913074 | Other | Feb. 22, 2044Active | Discovered |
| 11865175 | Method-of-use (carveable) | Jan. 4, 2044Active | Discovered |
| 11603411 | Formulation/compound | Mar. 9, 2043Active | Discovered |
| 11596620 | Formulation/compound | Mar. 2, 2043Active | Discovered |
| 11466087 | Formulation/compound | Oct. 6, 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 264 AI-discovered patents by relevance.
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kaylin Bower FDA-2025-P-1093 · 3 docket documents Kaylin Bower, founder of an MS advocacy organization, filed a citizen petition requesting that the FDA amend the labeling for Ocrevus (ocrelizumab) to comply with 21 CFR 201.57(c)(2)(i)(B) by indicating in the "Indications and Usage" and "Clinical Studies" sections that the drug showed efficacy only | Other | 2025-04-17 | Open | Kaylin Bower |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.