INSULIN HUMAN | B208157 | BAXTER HLTHCARE CORP
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 12427187(composition)· AI-discovered, not Purple-Book-listed · relevance 88/100. This caps practical skinny-label entry; it does not move the licensure floor above.
38 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12427187 | Formulation/compound | Sep. 25, 2045Active | Discovered |
| 12357562 | Formulation/compound | Jul. 10, 2045Active | Discovered |
| 12343383 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12325732 | Formulation/compound | Jun. 5, 2045Active | Discovered |
| 12233114 | Method-of-use (carveable) | Feb. 20, 2045Active | Discovered |
| 12152063 | Formulation/compound | Nov. 21, 2044Active | Discovered |
| 12122818 | Formulation/compound | Oct. 17, 2044Active | Discovered |
| 11872266 | Formulation/compound | Jan. 11, 2044Active | Discovered |
| 11707509 | Formulation/compound | Jul. 20, 2043Active | Discovered |
| 11673933 | Method-of-use (carveable) | Jun. 8, 2043Active | Discovered |
| 11498951 | Formulation/compound | Nov. 10, 2042Active | Discovered |
| 11278596 | Method-of-use (carveable) | Mar. 17, 2042Active | Discovered |
| 11207384 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11123406 | Formulation/compound | Sep. 16, 2041Active | Discovered |
| 11045601 | Other | Jun. 24, 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 365 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.