TILDRAKIZUMAB-ASMN | B761067 | SUN PHARMA GLOBAL
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 (Mar. 20, 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) | Mar. 20, 2030 | 3y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 20, 2030 | 3y 8mo 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 12350340(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
14 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421524 | Other | Sep. 18, 2045Active | Discovered |
| 12350340 | Formulation/compound | Jul. 3, 2045Active | Discovered |
| 12162938 | Other | Dec. 5, 2044Active | Discovered |
| 11999789 | Formulation/compound | May. 30, 2044Active | Discovered |
| 11959118 | Formulation/compound | Apr. 11, 2044Active | Discovered |
| 11554361 | Other | Jan. 12, 2043Active | Discovered |
| 11352421 | Method-of-use (carveable) | Jun. 2, 2042Active | Discovered |
| 11332544 | Formulation/compound | May. 12, 2042Active | Discovered |
| 11220668 | Other | Jan. 6, 2042Active | Discovered |
| 11207412 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11168134 | Method-of-use (carveable) | Nov. 4, 2041Active | Discovered |
| 11014986 | Formulation/compound | May. 20, 2041Active | Discovered |
| 10793592 | Other | Oct. 1, 2040Active | Discovered |
| 10640559 | Formulation/compound | Apr. 30, 2040Active | Discovered |
| 10519194 | Other | Dec. 26, 2039Active | Discovered |
Showing 15 of 33 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.
33 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.