INSULIN GLARGINE; LIXISENATIDE | B208673 | SANOFI-AVENTIS US
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 12303598(formulation)· AI-discovered, not Purple-Book-listed · relevance 72/100. This caps practical skinny-label entry; it does not move the licensure floor above.
19 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 26 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434003 | Other | Oct. 2, 2045Active | Discovered |
| 12377223 | Other | Jul. 31, 2045Active | Discovered |
| 12370314 | Other | Jul. 24, 2045Active | Discovered |
| 12329935 | Other | Jun. 12, 2045Active | Discovered |
| 12303598 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12274872 | Other | Apr. 10, 2045Active | Discovered |
| 12257287 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12239820 | Other | Feb. 27, 2045Active | Discovered |
| 12186374 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 12151084 | Other | Nov. 21, 2044Active | Discovered |
| 11590206 | Formulation/compound | Feb. 23, 2043Active | Discovered |
| 11560402 | Other | Jan. 19, 2043Active | Discovered |
| 11396534 | Formulation/compound | Jul. 21, 2042Active | Discovered |
| 11103649 | Other | Aug. 26, 2041Active | Discovered |
| 11026999 | Formulation/compound | Jun. 3, 2041Active | 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 141 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.