INSULIN GLARGINE RECOMBINANT | B206538 | SANOFI US SERVICES
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.
Latest formulation/compound patent 12186374(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 24 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434003 | Other | Oct. 2, 2045Active | Discovered |
| 12329935 | Other | Jun. 12, 2045Active | Discovered |
| 12214169 | Other | Jan. 30, 2045Active | Discovered |
| 12186374 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 11952602 | Other | Apr. 4, 2044Active | Discovered |
| 11759575 | Other | Sep. 14, 2043Active | Discovered |
| 11396534 | Formulation/compound | Jul. 21, 2042Active | Discovered |
| 11376365 | Other | Jun. 30, 2042Active | Discovered |
| 11191722 | Formulation/compound | Dec. 2, 2041Active | Discovered |
| 11160928 | Other | Oct. 28, 2041Active | Discovered |
| 11026999 | Formulation/compound | Jun. 3, 2041Active | Discovered |
| 10610595 | Formulation/compound | Apr. 2, 2040Active | Discovered |
| 10434147 | Method-of-use (carveable) | Oct. 3, 2039Active | Discovered |
| 10232125 | Other | Mar. 14, 2039Active | Discovered |
| 10117909 | Formulation/compound | Nov. 1, 2038Active | Discovered |
Showing 15 of 50 patents (latest expirations).
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.
Top 50 of 240 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.