ELRANATAMAB | B761345 | 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 (Aug. 14, 2023), 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) | Aug. 14, 2035 | 9y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 14, 2035 | 9y 1mo 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 92/100. This caps practical skinny-label entry; it does not move the licensure floor above.
47 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 3 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11814435 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11707529 | Formulation/compound | Jul. 20, 2043Active | Discovered |
| 11680087 | Formulation/compound | Jun. 15, 2043Active | Discovered |
| 11661438 | Formulation/compound | May. 25, 2043Active | Discovered |
| 11525010 | Formulation/compound | Dec. 8, 2042Active | Discovered |
| 11510959 | Formulation/compound | Nov. 24, 2042Active | Discovered |
| 11331376 | Formulation/compound | May. 12, 2042Active | Discovered |
| 11147865 | Formulation/compound | Oct. 14, 2041Active | Discovered |
| 11116829 | Formulation/compound | Sep. 9, 2041Active | Discovered |
| 10933112 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10912842 | Formulation/compound | Feb. 4, 2041Active | Discovered |
| 10899802 | Formulation/compound | Jan. 21, 2041Active | Discovered |
| 10829521 | Formulation/compound | Nov. 5, 2040Active | Discovered |
| 10787514 | Formulation/compound | Sep. 24, 2040Active | Discovered |
| 10787652 | Formulation/compound | Sep. 24, 2040Active | Discovered |
Showing 15 of 50 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.
Top 50 of 327 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.