TOCILIZUMAB | B125472 | 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 (Oct. 21, 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) | Oct. 21, 2025 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 4, 2028 | 2y 1mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease", protected through 2028-09-04) advances biosimilar entry from the full-label date to the estimated 12-year floor.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease(label indication #3) | Sep. 4, 2028 | Oct. 21, 2025(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Sep. 4, 2028
Orphan-drug exclusivity runs past the licensure floor above, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest at the floor date, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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 11767363(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
14 formulation/compound (cap skinny entry) · 23 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12291575 | Method-of-use (carveable) | May. 1, 2045Active | Discovered |
| 12098208 | Method-of-use (carveable) | Sep. 19, 2044Active | Discovered |
| 11851486 | Other | Dec. 21, 2043Active | Discovered |
| 11767363 | Formulation/compound | Sep. 21, 2043Active | Discovered |
| 11760804 | Method-of-use (carveable) | Sep. 14, 2043Active | Discovered |
| 11692037 | Method-of-use (carveable) | Jun. 29, 2043Active | Discovered |
| 11667720 | Method-of-use (carveable) | Jun. 1, 2043Active | Discovered |
| 11622969 | Method-of-use (carveable) | Apr. 6, 2043Active | Discovered |
| 11584798 | Formulation/compound | Feb. 16, 2043Active | Discovered |
| 11518814 | Method-of-use (carveable) | Dec. 1, 2042Active | Discovered |
| 11377678 | Other | Jun. 30, 2042Active | Discovered |
| 11359026 | Formulation/compound | Jun. 9, 2042Active | Discovered |
| 11285208 | Method-of-use (carveable) | Mar. 24, 2042Active | Discovered |
| 11174317 | Method-of-use (carveable) | Nov. 11, 2041Active | Discovered |
| 11136610 | Other | Sep. 30, 2041Active | Discovered |
Showing 15 of 50 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 221 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.