TRASTUZUMAB-PKRB | B761091 | 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 (Dec. 14, 2018), 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) | Dec. 14, 2030 | 4y 5mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 14, 2030 | 4y 5mo 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 12331134(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
25 formulation/compound (cap skinny entry) · 8 method-of-use (carveable — gate nothing) · 17 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12331134 | Formulation/compound | Jun. 12, 2045Active | Discovered |
| 12281153 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12269876 | Formulation/compound | Apr. 3, 2045Active | Discovered |
| 12173080 | Other | Dec. 19, 2044Active | Discovered |
| 12174184 | Other | Dec. 19, 2044Active | Discovered |
| 12128103 | Method-of-use (carveable) | Oct. 24, 2044Active | Discovered |
| 12065478 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 11992529 | Method-of-use (carveable) | May. 23, 2044Active | Discovered |
| 11976127 | Other | May. 2, 2044Active | Discovered |
| 11905325 | Other | Feb. 15, 2044Active | Discovered |
| 11802165 | Other | Oct. 26, 2043Active | Discovered |
| 11787873 | Formulation/compound | Oct. 12, 2043Active | Discovered |
| 11718678 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11666581 | Formulation/compound | Jun. 1, 2043Active | Discovered |
| 11638756 | Method-of-use (carveable) | Apr. 27, 2043Active | 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 224 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Genentech, Inc. et al v. Celltrion, Inc. et al 40 patentstrastuzumab (anti-HER2 antibody) | D. Del. | 2018-01-12 | Terminated 2018-12-27 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.