ADALIMUMAB-ADAZ | B761071 | SANDOZ INC
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 (Oct. 30, 2018), 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) | Oct. 30, 2030 | 4y 3mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Oct. 30, 2030 | 4y 3mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
First-interchangeable exclusivity (§ 262(k)(6)): Apr. 5, 2025 — blocks other interchangeable designations only. It never gates plain biosimilar licensure and does not enter any entry-LOE above.
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 11578428(composition)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 27 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12157767 | Other | Nov. 28, 2044Active | Discovered |
| 11779643 | Other | Oct. 5, 2043Active | Discovered |
| 11667696 | Other | Jun. 1, 2043Active | Discovered |
| 11612666 | Other | Mar. 23, 2043Active | Discovered |
| 11578428 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11510959 | Formulation/compound | Nov. 24, 2042Active | Discovered |
| 10941216 | Formulation/compound | Mar. 4, 2041Active | Discovered |
| 10933112 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10913984 | Other | Feb. 4, 2041Active | Discovered |
| 10793635 | Formulation/compound | Oct. 1, 2040Active | Discovered |
| 10792372 | Formulation/compound | Oct. 1, 2040Active | Discovered |
| 10647756 | Formulation/compound | May. 7, 2040Active | Discovered |
| 10494348 | Other | Nov. 28, 2039Active | Discovered |
| 10443035 | Other | Oct. 10, 2039Active | Discovered |
| 10188600 | Formulation/compound | Jan. 24, 2039Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 76 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.