BENRALIZUMAB | B761070 | ASTRAZENECA AB
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 (Nov. 14, 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) | Nov. 14, 2029 | 3y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Sep. 17, 2031 | 5y 2mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)", protected through 2031-09-17) 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 adult patients with eosinophilic granulomatosis with polyangiitis (EGPA)(label indication #4) | Sep. 17, 2031 | Nov. 14, 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 · Sep. 17, 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 12178876(composition)· AI-discovered, not Purple-Book-listed · relevance 50/100. This caps practical skinny-label entry; it does not move the licensure floor above.
14 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 12 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12297501 | Other | May. 8, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12173075 | Formulation/compound | Dec. 19, 2044Active | Discovered |
| 11912782 | Formulation/compound | Feb. 22, 2044Active | Discovered |
| 11482315 | Other | Oct. 20, 2042Active | Discovered |
| 10744204 | Formulation/compound | Aug. 13, 2040Active | Discovered |
| 10618952 | Other | Apr. 9, 2040Active | Discovered |
| 10556955 | Other | Feb. 6, 2040Active | Discovered |
| 10259842 | Other | Apr. 11, 2039Active | Discovered |
| 9968687 | Formulation/compound | May. 10, 2038Active | Discovered |
| 9919056 | Formulation/compound | Mar. 15, 2038Active | Discovered |
| 9527927 | Formulation/compound | Dec. 22, 2036Active | Discovered |
| 9441046 | Method-of-use (carveable) | Sep. 8, 2036Active | Discovered |
| 9441047 | Method-of-use (carveable) | Sep. 8, 2036Active | Discovered |
| 9441037 | Method-of-use (carveable) | Sep. 8, 2036Active | Discovered |
Showing 15 of 29 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.
29 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.