DEPEMOKIMAB-ULAA | B761458 | GLAXOSMITHKLINE LLC
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Dec. 16, 2025 — 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 12076385(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
39 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358945 | Other | Jul. 10, 2045Active | Discovered |
| 12234293 | Method-of-use (carveable) | Feb. 20, 2045Active | Discovered |
| 12076385 | Formulation/compound | Aug. 29, 2044Active | Discovered |
| 11667887 | Other | Jun. 1, 2043Active | Discovered |
| 11530238 | Other | Dec. 15, 2042Active | Discovered |
| 11427643 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11401334 | Method-of-use (carveable) | Jul. 28, 2042Active | Discovered |
| 11291635 | Formulation/compound | Mar. 31, 2042Active | Discovered |
| 10676503 | Other | Jun. 4, 2040Active | Discovered |
| 9534246 | Other | Dec. 29, 2036Active | Discovered |
| 9365624 | Formulation/compound | Jun. 9, 2036Active | Discovered |
| 9265821 | Formulation/compound | Feb. 18, 2036Active | Discovered |
| 9067987 | Formulation/compound | Jun. 25, 2035Active | Discovered |
| 9056075 | Formulation/compound | Jun. 11, 2035Active | Discovered |
| 9011869 | Formulation/compound | Apr. 16, 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 134 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.