FILGRASTIM-AAFI | B761080 | HOSPIRA 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 (Jul. 20, 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) | Jul. 20, 2030 | 4y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 20, 2030 | 4y 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 11813328(formulation)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
11 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 38 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12325737 | Other | Jun. 5, 2045Active | Discovered |
| 12312381 | Other | May. 22, 2045Active | Discovered |
| 12269843 | Other | Apr. 3, 2045Active | Discovered |
| 12195779 | Other | Jan. 9, 2045Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11786866 | Other | Oct. 12, 2043Active | Discovered |
| 11534547 | Other | Dec. 22, 2042Active | Discovered |
| 11486883 | Other | Oct. 27, 2042Active | Discovered |
| 11427627 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11130980 | Other | Sep. 23, 2041Active | Discovered |
| 11040102 | Formulation/compound | Jun. 17, 2041Active | Discovered |
| 10822630 | Other | Oct. 29, 2040Active | Discovered |
| 10738334 | Formulation/compound | Aug. 6, 2040Active | Discovered |
| 10668154 | Formulation/compound | May. 28, 2040Active | 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 66 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2020-04-24 | Terminated 2021-09-08 | — | |
| D. Del. | 2018-07-18 | Terminated 2021-09-08 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.