MOGAMULIZUMAB-KPKC | B761051 | KYOWA KIRIN
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. 8, 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) | Aug. 8, 2030 | 4y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 8, 2030 | 4y 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 10994011(formulation)· AI-discovered, not Purple-Book-listed · relevance 65/100. This caps practical skinny-label entry; it does not move the licensure floor above.
12 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 10 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11970535 | Method-of-use (carveable) | Apr. 25, 2044Active | Discovered |
| 11286459 | Other | Mar. 24, 2042Active | Discovered |
| 10994011 | Formulation/compound | Apr. 29, 2041Active | Discovered |
| 10590203 | Formulation/compound | Mar. 12, 2040Active | Discovered |
| 10584172 | Formulation/compound | Mar. 5, 2040Active | Discovered |
| 10448622 | Formulation/compound | Oct. 17, 2039Active | Discovered |
| 10358671 | Other | Jul. 18, 2039Active | Discovered |
| 10294302 | Method-of-use (carveable) | May. 16, 2039Active | Discovered |
| 10131711 | Formulation/compound | Nov. 15, 2038Active | Discovered |
| 10076103 | Other | Sep. 13, 2038Active | Discovered |
| 10023649 | Method-of-use (carveable) | Jul. 12, 2038Active | Discovered |
| 9976163 | Other | May. 17, 2038Active | Discovered |
| 9725750 | Other | Aug. 3, 2037Active | Discovered |
| 9675625 | Method-of-use (carveable) | Jun. 8, 2037Active | Discovered |
| 9650411 | Other | May. 11, 2037Active | Discovered |
Showing 15 of 27 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.
27 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.