RANIBIZUMAB-EQRN | B761165 | SANDOZ INC
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 (Aug. 2, 2022), 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) | Aug. 2, 2034 | 8y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Aug. 2, 2034 | 8y remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
First-interchangeable exclusivity (§ 262(k)(6)): Oct. 3, 2023 — blocks other interchangeable designations only. It never gates plain biosimilar licensure and does not enter any entry-LOE above.
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 12269876(composition)· AI-discovered, not Purple-Book-listed · relevance 72/100. This caps practical skinny-label entry; it does not move the licensure floor above.
31 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12371510 | Other | Jul. 24, 2045Active | Discovered |
| 12331075 | Other | Jun. 12, 2045Active | Discovered |
| 12269876 | Formulation/compound | Apr. 3, 2045Active | Discovered |
| 11976127 | Other | May. 2, 2044Active | Discovered |
| 11891432 | Formulation/compound | Feb. 1, 2044Active | Discovered |
| 11767370 | Other | Sep. 21, 2043Active | Discovered |
| 11680110 | Other | Jun. 15, 2043Active | Discovered |
| 11555076 | Formulation/compound | Jan. 12, 2043Active | Discovered |
| 11407794 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11299539 | Other | Apr. 7, 2042Active | Discovered |
| 11230718 | Other | Jan. 20, 2042Active | Discovered |
| 11103584 | Formulation/compound | Aug. 26, 2041Active | Discovered |
| 11078243 | Formulation/compound | Jul. 29, 2041Active | Discovered |
| 10899841 | Formulation/compound | Jan. 21, 2041Active | Discovered |
| 10781268 | Formulation/compound | Sep. 17, 2040Active | Discovered |
Showing 15 of 50 patents (latest expirations).
Approved Biosimilars
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 230 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.