ETANERCEPT | B103795 | IMMUNEX
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Nov. 2, 1998 — 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 | May. 27, 2006 | 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 12214013(formulation)· AI-discovered, not Purple-Book-listed · relevance 94/100. This caps practical skinny-label entry; it does not move the licensure floor above.
38 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12214013 | Formulation/compound | Jan. 30, 2045Active | Discovered |
| 12209122 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12070488 | Method-of-use (carveable) | Aug. 22, 2044Active | Discovered |
| 11952399 | Other | Apr. 4, 2044Active | Discovered |
| 11491223 | Formulation/compound | Nov. 3, 2042Active | Discovered |
| 11236146 | Formulation/compound | Jan. 27, 2042Active | Discovered |
| 11135267 | Formulation/compound | Sep. 30, 2041Active | Discovered |
| 11129876 | Formulation/compound | Sep. 23, 2041Active | Discovered |
| 11104714 | Formulation/compound | Aug. 26, 2041Active | Discovered |
| 11000588 | Formulation/compound | May. 6, 2041Active | Discovered |
| 11001627 | Other | May. 6, 2041Active | Discovered |
| 10987405 | Formulation/compound | Apr. 22, 2041Active | Discovered |
| 10980885 | Formulation/compound | Apr. 15, 2041Active | Discovered |
| 10980884 | Formulation/compound | Apr. 15, 2041Active | Discovered |
| 10959939 | Formulation/compound | Mar. 25, 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 270 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2019-04-30 | Terminated 2021-11-03 | — | |
| D.N.J. | 2016-02-26 | Terminated 2019-10-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.