BUROSUMAB-TWZA | B761068 | 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 (Apr. 17, 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) | Apr. 17, 2030 | 3y 9mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 17, 2030 | 3y 9mo 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 10448622(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
4 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 8 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12358976 | Method-of-use (carveable) | Jul. 10, 2045Active | Discovered |
| 11771748 | Method-of-use (carveable) | Sep. 28, 2043Active | Discovered |
| 11202822 | Method-of-use (carveable) | Dec. 16, 2041Active | Discovered |
| 10639360 | Method-of-use (carveable) | Apr. 30, 2040Active | Discovered |
| 10448622 | Formulation/compound | Oct. 17, 2039Active | Discovered |
| 10358671 | Other | Jul. 18, 2039Active | Discovered |
| 10076103 | Other | Sep. 13, 2038Active | Discovered |
| 9725750 | Other | Aug. 3, 2037Active | Discovered |
| 9499838 | Formulation/compound | Nov. 17, 2036Active | Discovered |
| 9426970 | Other | Aug. 25, 2036Active | Discovered |
| 8835712 | Other | Sep. 11, 2034Active | Discovered |
| 8809045 | Formulation/compound | Aug. 14, 2034Active | Discovered |
| 8110671 | Other | Feb. 2, 2032Active | Discovered |
| 7883705 | Formulation/compound | Feb. 3, 2031Active | Discovered |
| 7816578 | Other | Oct. 14, 2030Active | Discovered |
Showing 15 of 16 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.
16 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.