PEGFILGRASTIM-APGF | B761111 | 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 (Jun. 10, 2020), 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) | Jun. 10, 2032 | 5y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 10, 2032 | 5y 11mo 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.
17 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 33 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12290666 | Other | May. 1, 2045Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11786866 | Other | Oct. 12, 2043Active | Discovered |
| 11486883 | Other | Oct. 27, 2042Active | Discovered |
| 11384378 | Other | Jul. 7, 2042Active | Discovered |
| 11384140 | Other | Jul. 7, 2042Active | Discovered |
| 11167082 | Other | Nov. 4, 2041Active | Discovered |
| 11130980 | Other | Sep. 23, 2041Active | Discovered |
| 11033684 | Other | Jun. 10, 2041Active | Discovered |
| 10941182 | Formulation/compound | Mar. 4, 2041Active | Discovered |
| 10738334 | Formulation/compound | Aug. 6, 2040Active | Discovered |
| 10653781 | Formulation/compound | May. 14, 2040Active | Discovered |
| 10646664 | Other | May. 7, 2040Active | Discovered |
| 10646652 | Other | May. 7, 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 58 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.