BLINATUMOMAB | B125557 | AMGEN
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. 3, 2014), 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. 3, 2026 | 4mo 19d remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 14, 2031 | 4y 11mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older", protected through 2031-06-14) 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 |
|---|---|---|
| treatment of CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy in adult and pediatric patients one month and older | Jun. 14, 2031 | Dec. 3, 2026(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 · Jun. 14, 2031
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 12415852(composition)· AI-discovered, not Purple-Book-listed · relevance 87/100. This caps practical skinny-label entry; it does not move the licensure floor above.
36 formulation/compound (cap skinny entry) · 12 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12415852 | Formulation/compound | Sep. 11, 2045Active | Discovered |
| 12384852 | Formulation/compound | Aug. 7, 2045Active | Discovered |
| 12344674 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12281176 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12258404 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12257343 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12251474 | Formulation/compound | Mar. 13, 2045Active | Discovered |
| 11905328 | Formulation/compound | Feb. 15, 2044Active | Discovered |
| 11732052 | Formulation/compound | Aug. 17, 2043Active | Discovered |
| 11685784 | Formulation/compound | Jun. 22, 2043Active | Discovered |
| 11666660 | Formulation/compound | Jun. 1, 2043Active | Discovered |
| 11661462 | Formulation/compound | May. 25, 2043Active | Discovered |
| 11639389 | Formulation/compound | Apr. 27, 2043Active | Discovered |
| 11633408 | Method-of-use (carveable) | Apr. 20, 2043Active | Discovered |
| 11579142 | Method-of-use (carveable) | Feb. 9, 2043Active | Discovered |
Showing 15 of 50 patents (latest expirations).
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 72 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2022-01-10 | Terminated 2025-10-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.