TOCILIZUMAB | B125276 | GENENTECH
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jan. 8, 2010 — 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 | Feb. 28, 2025 | 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 10662245(composition)· AI-discovered, not Purple-Book-listed · relevance 82/100. This caps practical skinny-label entry; it does not move the licensure floor above.
43 formulation/compound (cap skinny entry) · 12 method-of-use (carveable — gate nothing) · 18 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12291575 | Method-of-use (carveable) | May. 1, 2045Active | Discovered |
| 12209109 | Other | Jan. 23, 2045Active | Discovered |
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12098208 | Method-of-use (carveable) | Sep. 19, 2044Active | Discovered |
| 12016900 | Method-of-use (carveable) | Jun. 20, 2044Active | Discovered |
| 12016328 | Other | Jun. 20, 2044Active | Discovered |
| 11851486 | Other | Dec. 21, 2043Active | Discovered |
| 11760804 | Method-of-use (carveable) | Sep. 14, 2043Active | Discovered |
| 11692037 | Method-of-use (carveable) | Jun. 29, 2043Active | Discovered |
| 11674951 | Other | Jun. 8, 2043Active | Discovered |
| 11634836 | Other | Apr. 20, 2043Active | Discovered |
| 11622969 | Method-of-use (carveable) | Apr. 6, 2043Active | Discovered |
| 11518814 | Method-of-use (carveable) | Dec. 1, 2042Active | Discovered |
| 11285208 | Method-of-use (carveable) | Mar. 24, 2042Active | Discovered |
| 11046772 | Other | Jun. 24, 2041Active | Discovered |
Showing 15 of 73 patents (latest expirations).
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.
Top 50 of 209 AI-discovered patents by relevance.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2022-01065 | 10231981 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2022-06-07 | — |
| IPR2021-01025 | 10744201 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-06-28 | — |
| IPR2022-00579 | 10874677 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2022-02-21 | 2024-03-07 |
| IPR2021-01336 | 10874677 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-08-18 | 2022-10-17 |
| IPR2017-01357 | 7332289 | IPR | Pfizer, Inc. | Final Written Decision | 2017-05-19 | — |
| IPR2021-01024 | 7521052 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-06-28 | — |
| IPR2022-00578 | 8580264 | IPR | Celltrion, Inc. et al. | Final Written Decision | 2022-02-21 | 2024-03-07 |
| IPR2021-01542 | 8580264 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-09-24 | 2022-10-17 |
| IPR2021-01288 | 8580264 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-08-18 | 2022-10-17 |
| IPR2022-00201 | 9750752 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2021-11-24 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Mass. | 2023-07-13 | Terminated 2023-10-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.