ADALIMUMAB-AFZB | B761118 | PFIZER 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 (Nov. 15, 2019), 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. 15, 2031 | 5y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 15, 2031 | 5y 4mo 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 11814435· AI-discovered, not Purple-Book-listed · relevance 62/100. This caps practical skinny-label entry; it does not move the licensure floor above.
27 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 21 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11814435 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11746154 | Formulation/compound | Aug. 31, 2043Active | Discovered |
| 11718864 | Formulation/compound | Aug. 3, 2043Active | Discovered |
| 11674240 | Formulation/compound | Jun. 8, 2043Active | Discovered |
| 11319526 | Formulation/compound | Apr. 28, 2042Active | Discovered |
| 11230610 | Formulation/compound | Jan. 20, 2042Active | Discovered |
| 11180552 | Formulation/compound | Nov. 18, 2041Active | Discovered |
| 11135308 | Formulation/compound | Sep. 30, 2041Active | Discovered |
| 10912842 | Formulation/compound | Feb. 4, 2041Active | Discovered |
| 10647756 | Formulation/compound | May. 7, 2040Active | Discovered |
| 10494348 | Other | Nov. 28, 2039Active | Discovered |
| 10328084 | Formulation/compound | Jun. 20, 2039Active | Discovered |
| 10208109 | Formulation/compound | Feb. 14, 2039Active | Discovered |
| 10188600 | Formulation/compound | Jan. 24, 2039Active | Discovered |
| 10183117 | Other | Jan. 17, 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 83 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.