ALIROCUMAB | B125559 | 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 (Jul. 24, 2015), 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) | Jul. 24, 2027 | 1y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Apr. 1, 2028 | 1y 8mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C", protected through 2028-04-01) 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 |
|---|---|---|
| as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C(label indication #5) | Apr. 1, 2028 | Jul. 24, 2027(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 · Apr. 1, 2028
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 12070502(formulation)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
13 formulation/compound (cap skinny entry) · 6 method-of-use (carveable — gate nothing) · 31 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12389888 | Other | Aug. 14, 2045Active | Discovered |
| 12378557 | Method-of-use (carveable) | Jul. 31, 2045Active | Discovered |
| 12356967 | Other | Jul. 10, 2045Active | Discovered |
| 12281173 | Method-of-use (carveable) | Apr. 17, 2045Active | Discovered |
| 12274872 | Other | Apr. 10, 2045Active | Discovered |
| 12070502 | Formulation/compound | Aug. 22, 2044Active | Discovered |
| 12055551 | Other | Aug. 1, 2044Active | Discovered |
| 11912741 | Other | Feb. 22, 2044Active | Discovered |
| 11904017 | Method-of-use (carveable) | Feb. 15, 2044Active | Discovered |
| 11685943 | Other | Jun. 22, 2043Active | Discovered |
| 11680254 | Formulation/compound | Jun. 15, 2043Active | Discovered |
| 11679146 | Method-of-use (carveable) | Jun. 15, 2043Active | Discovered |
| 11612151 | Formulation/compound | Mar. 23, 2043Active | Discovered |
| 11559050 | Other | Jan. 19, 2043Active | Discovered |
| 11512144 | Other | Nov. 24, 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 238 AI-discovered patents by relevance.
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2014-11-11 | Terminated 2017-01-05 | — | |
| D. Del. | 2014-10-28 | Terminated 2017-01-05 | — | |
| D. Del. | 2014-10-17 | Terminated 2019-10-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
No patent or exclusivity listings for this strength.