USTEKINUMAB | B761044 | JANSSEN BIOTECH
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Sep. 23, 2016 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of pediatric patients 2 years of age and older with moderately to severely active ulcerative colitis | Aug. 28, 2033 | Apr. 15, 2033(next orphan wall) |
| treatment of pediatric patients 2 years of age and older with moderately to severely active Crohn's disease | Apr. 15, 2033 | Open now(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.
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 12161716(composition)· AI-discovered, not Purple-Book-listed · relevance 89/100. This caps practical skinny-label entry; it does not move the licensure floor above.
35 formulation/compound (cap skinny entry) · 13 method-of-use (carveable — gate nothing) · 6 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12404324 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12379368 | Other | Jul. 31, 2045Active | Discovered |
| 12234283 | Other | Feb. 20, 2045Active | Discovered |
| 12161716 | Formulation/compound | Dec. 5, 2044Active | Discovered |
| 12138295 | Method-of-use (carveable) | Nov. 7, 2044Active | Discovered |
| 12129293 | Formulation/compound | Oct. 24, 2044Active | Discovered |
| 12098196 | Other | Sep. 19, 2044Active | Discovered |
| 12091452 | Method-of-use (carveable) | Sep. 12, 2044Active | Discovered |
| 12018057 | Formulation/compound | Jun. 20, 2044Active | Discovered |
| 11952417 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11719704 | Other | Aug. 3, 2043Active | Discovered |
| 11578124 | Method-of-use (carveable) | Feb. 9, 2043Active | Discovered |
| 11548941 | Method-of-use (carveable) | Jan. 5, 2043Active | Discovered |
| 11332525 | Formulation/compound | May. 12, 2042Active | Discovered |
| 11220541 | Other | Jan. 6, 2042Active | Discovered |
Showing 15 of 54 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 83 AI-discovered patents by relevance.
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2023-01444 | 10961307 | IPR | Biocon Biologics Inc. et al. | Terminated-Settled | 2023-11-22 | 2024-03-04 |
| IPR2023-01103 | 10961307 | IPR | Samsung Bioepis Co., Ltd. | Terminated-Settled | 2023-06-21 | 2023-08-09 |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-11-29 | Terminated 2023-05-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.