ALBIGLUTIDE | B125431 | 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 (Apr. 15, 2014), 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. 15, 2026 | Passed | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 15, 2026 | Passed | 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 12257287(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
7 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 6 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358945 | Other | Jul. 10, 2045Active | Discovered |
| 12257287 | Formulation/compound | Mar. 20, 2045Active | Discovered |
| 11667887 | Other | Jun. 1, 2043Active | Discovered |
| 10286037 | Formulation/compound | May. 9, 2039Active | Discovered |
| 9938243 | Formulation/compound | Apr. 5, 2038Active | Discovered |
| 9926570 | Other | Mar. 22, 2038Active | Discovered |
| 9168288 | Method-of-use (carveable) | Oct. 22, 2035Active | Discovered |
| 9040668 | Formulation/compound | May. 21, 2035Active | Discovered |
| 8748377 | Formulation/compound | Jun. 5, 2034Active | Discovered |
| 8691763 | Method-of-use (carveable) | Apr. 3, 2034Active | Discovered |
| 8202837 | Method-of-use (carveable) | Jun. 14, 2032Active | Discovered |
| 7977306 | Formulation/compound | Jul. 7, 2031Active | Discovered |
| 7238660 | Formulation/compound | Jun. 28, 2027Active | Discovered |
| 6949372 | Other | Sep. 22, 2025Expired | Discovered |
| 6632425 | Other | Oct. 9, 2023Expired | Discovered |
Showing 15 of 16 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.
16 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.