DOSTARLIMAB-GXLY | B761174 | GLAXOSMITHKLINE
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 (Apr. 22, 2021), 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) | Apr. 22, 2033 | 6y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 22, 2033 | 6y 9mo 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 11479607(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
6 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12429485 | Other | Sep. 25, 2045Active | Discovered |
| 12415855 | Method-of-use (carveable) | Sep. 11, 2045Active | Discovered |
| 12358945 | Other | Jul. 10, 2045Active | Discovered |
| 12156872 | Method-of-use (carveable) | Nov. 28, 2044Active | Discovered |
| 11667887 | Other | Jun. 1, 2043Active | Discovered |
| 11661453 | Method-of-use (carveable) | May. 25, 2043Active | Discovered |
| 11530238 | Other | Dec. 15, 2042Active | Discovered |
| 11479607 | Formulation/compound | Oct. 20, 2042Active | Discovered |
| 11407830 | Method-of-use (carveable) | Aug. 4, 2042Active | Discovered |
| 11220676 | Other | Jan. 6, 2042Active | Discovered |
| 10537638 | Formulation/compound | Jan. 16, 2040Active | Discovered |
| 10302655 | Method-of-use (carveable) | May. 23, 2039Active | Discovered |
| 9868761 | Other | Jan. 11, 2038Active | Discovered |
| 7498027 | Method-of-use (carveable) | Feb. 26, 2029Active | Discovered |
| 7465707 | Formulation/compound | Dec. 11, 2028Active | Discovered |
Showing 15 of 19 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.
19 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.