Testing version — LOERadar is in active testing. Features and data may change.
LEUKINE (SARGRAMOSTIM) | LOERadar
LEUKINE
BLA
SARGRAMOSTIM | B103362 | BERLEX LABS
2 products0 Purple Book patents
Biologic LOELicensure floor passed
No 12-year reference-product exclusivity floor found in the Purple Book
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Mar. 5, 1991 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
Scenario
Date
Status
Controlling
Best-skinny entry (floor)
Open now
Open now
no live licensure floor
Full-label entry
Mar. 29, 2025
Passed
no live block
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.
Jan. 2, 20456745 days remaining
Latest formulation/compound patent 12187803(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.