Testing version — LOERadar is in active testing. Features and data may change.
ADMELOG (INSULIN LISPRO) | LOERadar
ADMELOG
BLA
INSULIN LISPRO | B209196 | SANOFI-AVENTIS US
3 products0 Purple Book patents
Biologic LOEDeemed transition product
Deemed transition product — no fresh 12-year reference-product exclusivity
Deemed transition product — no fresh 12-year exclusivity
Approved as an NDA and deemed licensed under PHS Act § 351(a) on March 23, 2020 (BPCIA transition — insulins, human growth hormone, etc.). Under § 262(k)(7)(D) a deemed product receives no fresh 12-year reference-product exclusivity, so no BPCIA floor date is computed here. A biosimilar is not blocked by any 12-year exclusivity; any orphan or pediatric exclusivity is preserved and shown below.
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. 22, 20456885 days remaining
Latest formulation/compound patent 12312390(composition)· 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.