EFGARTIGIMOD ALFA AND HYALURONIDASE-QVFC | B761304 | ARGENX BV
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 (Jun. 20, 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) | Jun. 20, 2035 | 8y 11mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jun. 20, 2035 | 8y 11mo 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 12344678(composition)· AI-discovered, not Purple-Book-listed · relevance 90/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 17 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12403175 | Method-of-use (carveable) | Aug. 28, 2045Active | Discovered |
| 12344678 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12280110 | Formulation/compound | Apr. 17, 2045Active | Discovered |
| 12240875 | Method-of-use (carveable) | Feb. 27, 2045Active | Discovered |
| 12214920 | Other | Jan. 30, 2045Active | Discovered |
| 12202900 | Method-of-use (carveable) | Jan. 16, 2045Active | Discovered |
| 12180293 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12071486 | Formulation/compound | Aug. 22, 2044Active | Discovered |
| 12048794 | Other | Jul. 25, 2044Active | Discovered |
| 11850315 | Other | Dec. 21, 2043Active | Discovered |
| 11827701 | Formulation/compound | Nov. 23, 2043Active | Discovered |
| 11746140 | Formulation/compound | Aug. 31, 2043Active | Discovered |
| 11712468 | Method-of-use (carveable) | Jul. 27, 2043Active | Discovered |
| 11649295 | Formulation/compound | May. 11, 2043Active | Discovered |
| 11628230 | Other | Apr. 13, 2043Active | Discovered |
Showing 15 of 45 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.
45 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.