Testing version — LOERadar is in active testing. Features and data may change.
COSENTYX (SECUKINUMAB) | LOERadar
COSENTYX
BLA
SECUKINUMAB | B125504 | NOVARTIS PHARMS CORP
1 product0 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 Jan. 21, 2015 — 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.
May. 8, 20456760 days remaining
Latest formulation/compound patent 12296008(formulation)· AI-discovered, not Purple-Book-listed · relevance 98/100. 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.