EVINACUMAB-DGNB | B761181 | REGENERON PHARMACEUTICALS
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 11, 2021 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | Mar. 21, 2030 | 3y 4mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2030-03-21) advances biosimilar entry from the full-label date to now (no remaining licensure floor). Product-level orphan data — the specific indication(s) to drop are not yet attributed.
Carveable orphan wall · Mar. 21, 2030
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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 12269889(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
17 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 29 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12437836 | Method-of-use (carveable) | Oct. 2, 2045Active | Discovered |
| 12433264 | Other | Oct. 2, 2045Active | Discovered |
| 12281173 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12269889 | Formulation/compound | Apr. 3, 2045Active | Discovered |
| 12163122 | Other | Dec. 5, 2044Active | Discovered |
| 12152056 | Other | Nov. 21, 2044Active | Discovered |
| 12070502 | Formulation/compound | Aug. 22, 2044Active | Discovered |
| 12055551 | Other | Aug. 1, 2044Active | Discovered |
| 12042538 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 12031151 | Other | Jul. 4, 2044Active | Discovered |
| 12000839 | Other | May. 30, 2044Active | Discovered |
| 11884698 | Other | Jan. 25, 2044Active | Discovered |
| 11885811 | Other | Jan. 25, 2044Active | Discovered |
| 11780910 | Formulation/compound | Oct. 5, 2043Active | Discovered |
| 11559050 | Other | Jan. 19, 2043Active | 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 95 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.