DULAGLUTIDE | B125469 | ELI LILLY AND CO
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Sep. 18, 2014 — 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 12410227(composition)· AI-discovered, not Purple-Book-listed · relevance 72/100. This caps practical skinny-label entry; it does not move the licensure floor above.
23 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12410227 | Formulation/compound | Sep. 4, 2045Active | Discovered |
| 12397119 | Other | Aug. 21, 2045Active | Discovered |
| 12371465 | Formulation/compound | Jul. 24, 2045Active | Discovered |
| 12365716 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12257287 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 12084485 | Formulation/compound | Sep. 5, 2044Active | Discovered |
| 12059452 | Formulation/compound | Aug. 8, 2044Active | Discovered |
| 12023470 | Other | Jun. 27, 2044Active | Discovered |
| 11976136 | Formulation/compound | May. 2, 2044Active | Discovered |
| 11890325 | Method-of-use (carveable) | Feb. 1, 2044Active | Discovered |
| 11834486 | Formulation/compound | Nov. 30, 2043Active | Discovered |
| 11576950 | Method-of-use (carveable) | Feb. 9, 2043Active | Discovered |
| 11542313 | Formulation/compound | Dec. 29, 2042Active | Discovered |
| 11529470 | Other | Dec. 15, 2042Active | Discovered |
| 11253574 | Formulation/compound | Feb. 17, 2042Active | Discovered |
Showing 15 of 36 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.
36 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.