INFLIXIMAB-DYYB | B125544 | CELLTRION 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 (Apr. 5, 2016), 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) | Apr. 5, 2028 | 1y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 5, 2028 | 1y 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 12303483(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12291797 | Formulation/compound | May. 1, 2045Active | Discovered |
| 12227593 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 12084475 | Other | Sep. 5, 2044Active | Discovered |
| 11220531 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 11124573 | Formulation/compound | Sep. 16, 2041Active | Discovered |
| 10053513 | Formulation/compound | Aug. 16, 2038Active | Discovered |
| 8980626 | Other | Mar. 12, 2035Active | Discovered |
| 8975040 | Formulation/compound | Mar. 5, 2035Active | Discovered |
| 8921522 | Formulation/compound | Dec. 25, 2034Active | Discovered |
| 8703141 | Formulation/compound | Apr. 17, 2034Active | Discovered |
| 8617894 | Formulation/compound | Dec. 26, 2033Active | Discovered |
| 8580714 | Method-of-use (carveable) | Nov. 7, 2033Active | Discovered |
| 8415291 | Formulation/compound | Apr. 4, 2033Active | Discovered |
| 8318164 | Formulation/compound | Nov. 22, 2032Active | Discovered |
Showing 15 of 32 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.
32 AI-discovered patents, sorted by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Mass. | 2017-05-31 | Terminated 2018-07-31 | — | |
| D. Mass. | 2015-03-06 | Terminated 2018-03-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.