Testing version — LOERadar is in active testing. Features and data may change.
GRANIX (TBO-FILGRASTIM) | LOERadar
GRANIX
BLA
TBO-FILGRASTIM | B125294 | SICOR BIOTECH
2 products0 Purple Book patents
Biologic LOELicensure floor passed
The 12-year BPCIA reference-product exclusivity sets the earliest legal biosimilar licensure
Earliest legal licensure (12-year BPCIA floor)
February 29, 2024(869 days ago)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. FDA-stated in the Purple Book.
Full-label vs. best-skinny biosimilar entry
Scenario
Date
Status
Controlling
Best-skinny entry (floor)
Feb. 29, 2024
Passed
12-year RPE floor (non-carveable)
Full-label entry
Feb. 29, 2024
Passed
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.
Nov. 9, 20436324 days remaining
Latest formulation/compound patent 11813310(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
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.