DUPILUMAB | B761055 | REGENERON PHARMACEUTICALS
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. 28, 2017), 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. 28, 2029 | 2y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jan. 25, 2031 | 4y 6mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of pediatric patients aged 1 year and older weighing at least 15 kg who are less than 12 years of age or less than 40 kg in weight with eosinophilic esophagitis (EoE)", protected through 2031-01-25) advances biosimilar entry from the full-label date to the estimated 12-year floor.
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| treatment of pediatric patients aged 1 year and older weighing at least 15 kg who are less than 12 years of age or less than 40 kg in weight with eosinophilic esophagitis (EoE)(label indication #4) | Jan. 25, 2031 | Mar. 28, 2029(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Jan. 25, 2031
Orphan-drug exclusivity runs past the licensure floor above, 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 at the floor date, 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 11612151(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
16 formulation/compound (cap skinny entry) · 27 method-of-use (carveable — gate nothing) · 7 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12398212 | Method-of-use (carveable) | Aug. 21, 2045Active | Discovered |
| 12389888 | Other | Aug. 14, 2045Active | Discovered |
| 12359166 | Other | Jul. 10, 2045Active | Discovered |
| 12291571 | Method-of-use (carveable) | May. 1, 2045Active | Discovered |
| 12187792 | Method-of-use (carveable) | Jan. 2, 2045Active | Discovered |
| 12090201 | Method-of-use (carveable) | Sep. 12, 2044Active | Discovered |
| 11964016 | Method-of-use (carveable) | Apr. 18, 2044Active | Discovered |
| 11827671 | Method-of-use (carveable) | Nov. 23, 2043Active | Discovered |
| 11771743 | Method-of-use (carveable) | Sep. 28, 2043Active | Discovered |
| 11708415 | Method-of-use (carveable) | Jul. 20, 2043Active | Discovered |
| 11612151 | Formulation/compound | Mar. 23, 2043Active | Discovered |
| 11603408 | Method-of-use (carveable) | Mar. 9, 2043Active | Discovered |
| 11578135 | Formulation/compound | Feb. 9, 2043Active | Discovered |
| 11518807 | Formulation/compound | Dec. 1, 2042Active | Discovered |
| 11504426 | Method-of-use (carveable) | Nov. 17, 2042Active | 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 201 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Immunex Corporation v. Sanofi et al 1 patentdupilumab (anti-interleukin-4-receptor-alpha antibody) | C.D. Cal. | 2017-04-05 | Terminated 2021-08-02 | — |
| D. Mass. | 2017-03-20 | Terminated 2017-05-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.