CONCIZUMAB-MTCI | B761315 | NOVO NORDISK INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 20, 2024 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Dec. 20, 2031 | 5y 1mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2031-12-20) advances biosimilar entry from the full-label date to now (no remaining licensure floor). Product-level orphan data — the specific indication(s) to drop are not yet attributed.
Carveable orphan wall · Dec. 20, 2031
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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 11318191(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
24 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 20 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12249425 | Other | Mar. 6, 2045Active | Discovered |
| 12024542 | Other | Jun. 27, 2044Active | Discovered |
| 11787837 | Other | Oct. 12, 2043Active | Discovered |
| 11373746 | Method-of-use (carveable) | Jun. 23, 2042Active | Discovered |
| 11373759 | Other | Jun. 23, 2042Active | Discovered |
| 11318191 | Formulation/compound | Apr. 28, 2042Active | Discovered |
| 11274280 | Formulation/compound | Mar. 10, 2042Active | Discovered |
| 11208452 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11203636 | Method-of-use (carveable) | Dec. 16, 2041Active | Discovered |
| 10919949 | Formulation/compound | Feb. 11, 2041Active | Discovered |
| 10835602 | Formulation/compound | Nov. 12, 2040Active | Discovered |
| 9963496 | Formulation/compound | May. 3, 2038Active | Discovered |
| 9795674 | Formulation/compound | Oct. 19, 2037Active | Discovered |
| 9474790 | Formulation/compound | Oct. 20, 2036Active | Discovered |
| 9187546 | Formulation/compound | Nov. 12, 2035Active | 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 238 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.