INSULIN ASPART-XJHZ | B761188 | BIOCON BIOLOGICS 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 (Jul. 15, 2025), 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. 15, 2037 | 11y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 15, 2037 | 11y 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)): Sep. 15, 2026 — 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 12227528(composition)· AI-discovered, not Purple-Book-listed · relevance 70/100. This caps practical skinny-label entry; it does not move the licensure floor above.
24 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 23 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12249425 | Other | Mar. 6, 2045Active | Discovered |
| 12227528 | Formulation/compound | Feb. 13, 2045Active | Discovered |
| 11628256 | Other | Apr. 13, 2043Active | Discovered |
| 11472835 | Other | Oct. 13, 2042Active | Discovered |
| 11462313 | Other | Sep. 29, 2042Active | Discovered |
| 11400225 | Other | Jul. 28, 2042Active | Discovered |
| 11373746 | Method-of-use (carveable) | Jun. 23, 2042Active | Discovered |
| 11311679 | Other | Apr. 21, 2042Active | Discovered |
| 11208452 | Formulation/compound | Dec. 23, 2041Active | Discovered |
| 11164668 | Other | Oct. 28, 2041Active | Discovered |
| 10919949 | Formulation/compound | Feb. 11, 2041Active | Discovered |
| 10914728 | Other | Feb. 4, 2041Active | Discovered |
| 10596229 | Method-of-use (carveable) | Mar. 19, 2040Active | Discovered |
| 10406291 | Other | Sep. 5, 2039Active | Discovered |
| 10259856 | Formulation/compound | Apr. 11, 2039Active | 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 82 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.