FILGRASTIM-TXID | B761126 | TANVEX BIOPHARMA USA 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. 28, 2024), 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. 28, 2036 | 9y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 28, 2036 | 9y 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 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
29 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 15 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12390583 | Other | Aug. 14, 2045Active | Discovered |
| 12274736 | Method-of-use (carveable) | Apr. 10, 2045Active | Discovered |
| 12195779 | Other | Jan. 9, 2045Active | Discovered |
| 12029882 | Other | Jul. 4, 2044Active | Discovered |
| 11854779 | Other | Dec. 21, 2043Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11427627 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11389588 | Other | Jul. 14, 2042Active | Discovered |
| 11384140 | Other | Jul. 7, 2042Active | Discovered |
| 11229683 | Method-of-use (carveable) | Jan. 20, 2042Active | Discovered |
| 10822630 | Other | Oct. 29, 2040Active | Discovered |
| 10813913 | Formulation/compound | Oct. 22, 2040Active | Discovered |
| 10653781 | Formulation/compound | May. 14, 2040Active | Discovered |
| 10640542 | Formulation/compound | Apr. 30, 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 64 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| S.D. Cal. | 2019-07-23 | Terminated 2019-12-20 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.