MEPOLIZUMAB | B125526 | 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 (Nov. 4, 2015), 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) | Nov. 4, 2027 | 1y 3mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 4, 2027 | 1y 3mo 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 12187790(composition)· AI-discovered, not Purple-Book-listed · relevance 94/100. This caps practical skinny-label entry; it does not move the licensure floor above.
14 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 1 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12297501 | Other | May. 8, 2045Active | Discovered |
| 12187790 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 12187791 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 12187789 | Formulation/compound | Jan. 2, 2045Active | Discovered |
| 11459384 | Formulation/compound | Sep. 29, 2042Active | Discovered |
| 11325972 | Method-of-use (carveable) | May. 5, 2042Active | Discovered |
| 11299541 | Formulation/compound | Apr. 7, 2042Active | Discovered |
| 11286298 | Formulation/compound | Mar. 24, 2042Active | Discovered |
| 11274148 | Formulation/compound | Mar. 10, 2042Active | Discovered |
| 10870695 | Formulation/compound | Dec. 17, 2040Active | Discovered |
| 10537638 | Formulation/compound | Jan. 16, 2040Active | Discovered |
| 9834600 | Method-of-use (carveable) | Nov. 30, 2037Active | Discovered |
| 7402298 | Formulation/compound | Jul. 17, 2028Active | Discovered |
| 7399837 | Formulation/compound | Jul. 10, 2028Active | Discovered |
| 7189820 | Formulation/compound | Mar. 8, 2027Active | Discovered |
Showing 15 of 17 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.
17 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.