BEVACIZUMAB-TNJN | B761198 | BIO-THERA SOLUTIONS LTD
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 (Dec. 6, 2023), 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) | Dec. 6, 2035 | 9y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Dec. 6, 2035 | 9y 4mo 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 12121586(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
35 formulation/compound (cap skinny entry) · 10 method-of-use (carveable — gate nothing) · 5 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12121586 | Formulation/compound | Oct. 17, 2044Active | Discovered |
| 12078638 | Other | Aug. 29, 2044Active | Discovered |
| 11999791 | Other | May. 30, 2044Active | Discovered |
| 11891437 | Formulation/compound | Feb. 1, 2044Active | Discovered |
| 11820816 | Formulation/compound | Nov. 16, 2043Active | Discovered |
| 11732036 | Formulation/compound | Aug. 17, 2043Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11402382 | Other | Jul. 28, 2042Active | Discovered |
| 11384142 | Method-of-use (carveable) | Jul. 7, 2042Active | Discovered |
| 11254738 | Formulation/compound | Feb. 17, 2042Active | Discovered |
| 11111291 | Formulation/compound | Sep. 2, 2041Active | Discovered |
| 10925966 | Formulation/compound | Feb. 18, 2041Active | Discovered |
| 10906968 | Formulation/compound | Jan. 28, 2041Active | Discovered |
| 10683345 | Formulation/compound | Jun. 11, 2040Active | Discovered |
| 10617755 | Method-of-use (carveable) | Apr. 9, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 310 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.