INSULIN GLARGINE-YFGN | B761201 | MYLAN PHARMS 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. 28, 2021), 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. 28, 2033 | 7y remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Jul. 28, 2033 | 7y 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)): Nov. 15, 2022 — 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 11396534(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
7 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 43 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12420025 | Other | Sep. 18, 2045Active | Discovered |
| 12397117 | Other | Aug. 21, 2045Active | Discovered |
| 12391728 | Other | Aug. 14, 2045Active | Discovered |
| 12364820 | Other | Jul. 17, 2045Active | Discovered |
| 12318584 | Other | May. 29, 2045Active | Discovered |
| 12311153 | Other | May. 22, 2045Active | Discovered |
| 12090302 | Other | Sep. 12, 2044Active | Discovered |
| 11951292 | Other | Apr. 4, 2044Active | Discovered |
| 11918788 | Other | Feb. 29, 2044Active | Discovered |
| 11912741 | Other | Feb. 22, 2044Active | Discovered |
| 11884703 | Other | Jan. 25, 2044Active | Discovered |
| 11865318 | Other | Jan. 4, 2044Active | Discovered |
| 11779708 | Other | Oct. 5, 2043Active | Discovered |
| 11660395 | Other | May. 25, 2043Active | Discovered |
| 11577032 | Other | Feb. 9, 2043Active | 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 118 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.