TECLISTAMAB-CQYV | B761291 | JANSSEN BIOTECH
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 (Oct. 25, 2022), 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) | Oct. 25, 2034 | 8y 3mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Oct. 25, 2034 | 8y 3mo 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 12365743(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
34 formulation/compound (cap skinny entry) · 12 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12365743 | Formulation/compound | Jul. 17, 2045Active | Discovered |
| 12338289 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12098210 | Method-of-use (carveable) | Sep. 19, 2044Active | Discovered |
| 12077592 | Formulation/compound | Aug. 29, 2044Active | Discovered |
| 12065488 | Formulation/compound | Aug. 15, 2044Active | Discovered |
| 11952426 | Method-of-use (carveable) | Apr. 4, 2044Active | Discovered |
| 11844766 | Formulation/compound | Dec. 14, 2043Active | Discovered |
| 11725194 | Formulation/compound | Aug. 10, 2043Active | Discovered |
| 11365244 | Formulation/compound | Jun. 16, 2042Active | Discovered |
| 11359029 | Formulation/compound | Jun. 9, 2042Active | Discovered |
| 11236155 | Formulation/compound | Jan. 27, 2042Active | Discovered |
| 11149094 | Formulation/compound | Oct. 14, 2041Active | Discovered |
| 11096998 | Formulation/compound | Aug. 19, 2041Active | Discovered |
| 11078267 | Method-of-use (carveable) | Jul. 29, 2041Active | Discovered |
| 10934328 | Formulation/compound | Feb. 25, 2041Active | 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 218 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.