FREMANEZUMAB-VFRM | B761089 | TEVA PHARMS USA
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 (Sep. 14, 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) | Sep. 14, 2030 | 4y 2mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 14, 2030 | 4y 2mo 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 10899826(formulation)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
4 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 4 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 11541177 | Other | Dec. 29, 2042Active | Discovered |
| 11426706 | Other | Aug. 25, 2042Active | Discovered |
| 10899826 | Formulation/compound | Jan. 21, 2041Active | Discovered |
| 10323085 | Method-of-use (carveable) | Jun. 13, 2039Active | Discovered |
| 10232124 | Other | Mar. 14, 2039Active | Discovered |
| 9890211 | Formulation/compound | Feb. 8, 2038Active | Discovered |
| 9884908 | Formulation/compound | Feb. 1, 2038Active | Discovered |
| 9763993 | Other | Sep. 14, 2037Active | Discovered |
| 9505826 | Formulation/compound | Nov. 24, 2036Active | Discovered |
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.
9 AI-discovered patents, sorted by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Teva Pharmaceuticals International GmbH et al v. Eli Lilly and Company 4 patentsfremanezumab; galcanezumab | D. Mass. | 2021-06-07 | Terminated 2023-11-28 | — |
Teva Pharmaceuticals International GmbH et al v. Eli Lilly and Company 9 patentsfremanezumab (Teva product); galcanezumab (Eli Lilly product) | D. Mass. | 2018-09-27 | Terminated 2023-09-28 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.