SOMAPACITAN-BECO | B761156 | NOVO NORDISK INC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Aug. 28, 2020 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 10919949(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
8 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 20 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11596747 | Other | Mar. 2, 2043Active | Discovered |
| 11311679 | Other | Apr. 21, 2042Active | Discovered |
| 10919949 | Formulation/compound | Feb. 11, 2041Active | Discovered |
| 10376652 | Other | Aug. 8, 2039Active | Discovered |
| 10245383 | Other | Mar. 28, 2039Active | Discovered |
| 9861755 | Other | Jan. 4, 2038Active | Discovered |
| 9708383 | Formulation/compound | Jul. 13, 2037Active | Discovered |
| 9387176 | Formulation/compound | Jul. 7, 2036Active | Discovered |
| 9242011 | Formulation/compound | Jan. 21, 2036Active | Discovered |
| 9187546 | Formulation/compound | Nov. 12, 2035Active | Discovered |
| 9144647 | Other | Sep. 24, 2035Active | Discovered |
| 9067977 | Formulation/compound | Jun. 25, 2035Active | Discovered |
| 8916360 | Formulation/compound | Dec. 18, 2034Active | Discovered |
| 8637647 | Other | Jan. 23, 2034Active | Discovered |
| 8617125 | Other | Dec. 26, 2033Active | Discovered |
Showing 15 of 30 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.
30 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.