MOXETUMOMAB PASUDOTOX-TDFK | B761104 | INNATE PHARMA
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 (Sep. 13, 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) | Sep. 13, 2030 | 4y 1mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 13, 2030 | 4y 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 12377164(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
20 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12377164 | Formulation/compound | Jul. 31, 2045Active | Discovered |
| 12337038 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12209099 | Formulation/compound | Jan. 23, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11912782 | Formulation/compound | Feb. 22, 2044Active | Discovered |
| 11690918 | Formulation/compound | Jun. 29, 2043Active | Discovered |
| 11414477 | Other | Aug. 11, 2042Active | Discovered |
| 11370801 | Formulation/compound | Jun. 23, 2042Active | Discovered |
| 11136396 | Other | Sep. 30, 2041Active | Discovered |
| 10744204 | Formulation/compound | Aug. 13, 2040Active | Discovered |
| 10722594 | Formulation/compound | Jul. 23, 2040Active | Discovered |
| 10576164 | Formulation/compound | Feb. 27, 2040Active | Discovered |
| 10556955 | Other | Feb. 6, 2040Active | Discovered |
| 10328084 | Formulation/compound | Jun. 20, 2039Active | Discovered |
| 10259842 | Other | Apr. 11, 2039Active | Discovered |
Showing 15 of 28 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.
28 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.