TENECTEPLASE | B103909 | GENENTECH
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jun. 2, 2000 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 10933141(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
11 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 20 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12344859 | Other | Jun. 26, 2045Active | Discovered |
| 12338456 | Other | Jun. 19, 2045Active | Discovered |
| 12036384 | Method-of-use (carveable) | Jul. 11, 2044Active | Discovered |
| 11945837 | Other | Mar. 28, 2044Active | Discovered |
| 11905325 | Other | Feb. 15, 2044Active | Discovered |
| 11028149 | Other | Jun. 3, 2041Active | Discovered |
| 10933141 | Formulation/compound | Feb. 25, 2041Active | Discovered |
| 10745731 | Other | Aug. 13, 2040Active | Discovered |
| 10723762 | Other | Jul. 23, 2040Active | Discovered |
| 10590164 | Other | Mar. 12, 2040Active | Discovered |
| 10525137 | Formulation/compound | Jan. 2, 2040Active | Discovered |
| 10435694 | Other | Oct. 3, 2039Active | Discovered |
| 10188735 | Formulation/compound | Jan. 24, 2039Active | Discovered |
| 9994612 | Other | Jun. 7, 2038Active | Discovered |
| 9662395 | Formulation/compound | May. 25, 2037Active | Discovered |
Showing 15 of 34 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.
34 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.