Testing version — LOERadar is in active testing. Features and data may change.
XOLAIR (OMALIZUMAB) | LOERadar
XOLAIR
BLA
OMALIZUMAB | B103976 | GENENTECH
4 products8 Purple Book patents1 biosimilar
Biologic LOEBiosimilar competition
1 approved biosimilar
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 20, 2003 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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.
Sep. 25, 20457010 days remaining
Latest formulation/compound patent 12427193(formulation)· AI-discovered, not Purple-Book-listed · relevance 95/100. 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.