INSULIN ASPART; INSULIN DEGLUDEC | B203313 | NOVO
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 12227528(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
9 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 39 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12249425 | Other | Mar. 6, 2045Active | Discovered |
| 12227528 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 11672912 | Other | Jun. 8, 2043Active | Discovered |
| 11596747 | Other | Mar. 2, 2043Active | Discovered |
| 11491283 | Other | Nov. 3, 2042Active | Discovered |
| 11462313 | Other | Sep. 29, 2042Active | Discovered |
| 11395884 | Other | Jul. 21, 2042Active | Discovered |
| 11373746 | Method-of-use (carveable) | Jun. 23, 2042Active | Discovered |
| 11373759 | Other | Jun. 23, 2042Active | Discovered |
| 11311679 | Other | Apr. 21, 2042Active | Discovered |
| 11208452 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11103640 | Other | Aug. 26, 2041Active | Discovered |
| 11007327 | Other | May. 13, 2041Active | Discovered |
| 10919949 | Formulation/compound | Feb. 11, 2041Active | Discovered |
| 10914728 | Other | Feb. 4, 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 63 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.