BELIMUMAB | B761043 | GLAXOSMITHKLINE LLC
Earliest legal licensure (12-year BPCIA floor)
The 12-year reference-product exclusivity is the non-carveable floor — the earliest FDA could license a biosimilar for any indication. Unverified estimate — derived from the earliest available approval record (Jul. 20, 2017), not an FDA-stated exclusivity date. Shown with lower confidence than a Purple Book value.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Jul. 20, 2029 | 3y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 20, 2029 | 3y remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
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 12351610(composition)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
9 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358945 | Other | Jul. 10, 2045Active | Discovered |
| 12351610 | Formulation/compound | Jul. 3, 2045Active | Discovered |
| 12296007 | Formulation/compound | May. 8, 2045Active | Discovered |
| 12060431 | Method-of-use (carveable) | Aug. 8, 2044Active | Discovered |
| 11913074 | Other | Feb. 22, 2044Active | Discovered |
| 11913073 | Other | Feb. 22, 2044Active | Discovered |
| 11530238 | Other | Dec. 15, 2042Active | Discovered |
| 11220676 | Other | Jan. 6, 2042Active | Discovered |
| 11203632 | Formulation/compound | Dec. 16, 2041Active | Discovered |
| 11179463 | Formulation/compound | Nov. 18, 2041Active | Discovered |
| 11180569 | Method-of-use (carveable) | Nov. 18, 2041Active | Discovered |
| 10941448 | Other | Mar. 4, 2041Active | Discovered |
| 10563264 | Other | Feb. 13, 2040Active | Discovered |
| 10556009 | Formulation/compound | Feb. 6, 2040Active | Discovered |
| 10537638 | Formulation/compound | Jan. 16, 2040Active | Discovered |
Showing 15 of 22 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.
22 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.