RESLIZUMAB | B761033 | TEVA RESPIRATORY LLC
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. 23, 2016), 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. 23, 2028 | 1y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 23, 2028 | 1y 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 12059457(composition)· AI-discovered, not Purple-Book-listed · relevance 80/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 2 method-of-use (carveable — gate nothing) · 9 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12297501 | Other | May. 8, 2045Active | Discovered |
| 12059457 | Formulation/compound | Aug. 8, 2044Active | Discovered |
| 11572349 | Formulation/compound | Feb. 2, 2043Active | Discovered |
| 11426706 | Other | Aug. 25, 2042Active | Discovered |
| 11033634 | Formulation/compound | Jun. 10, 2041Active | Discovered |
| 10792372 | Formulation/compound | Oct. 1, 2040Active | Discovered |
| 10494348 | Other | Nov. 28, 2039Active | Discovered |
| 10053720 | Other | Aug. 16, 2038Active | Discovered |
| 10040852 | Formulation/compound | Aug. 2, 2038Active | Discovered |
| 9975948 | Other | May. 17, 2038Active | Discovered |
| 9944720 | Formulation/compound | Apr. 12, 2038Active | Discovered |
| 9872922 | Formulation/compound | Jan. 18, 2038Active | Discovered |
| 9855343 | Formulation/compound | Dec. 28, 2037Active | Discovered |
| 9598667 | Other | Mar. 16, 2037Active | Discovered |
| 9592293 | Formulation/compound | Mar. 9, 2037Active | Discovered |
Showing 15 of 24 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.
24 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.