PEGFILGRASTIM-UNNE | B761212 | LUPIN LTD
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. 28, 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) | Nov. 28, 2037 | 11y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 28, 2037 | 11y 4mo remaining | 12-year RPE floor |
Best-skinny equals full-label — no carveable orphan block runs past the licensure floor.
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 12178873(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
15 formulation/compound (cap skinny entry) · 1 method-of-use (carveable — gate nothing) · 34 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12390583 | Other | Aug. 14, 2045Active | Discovered |
| 12370317 | Other | Jul. 24, 2045Active | Discovered |
| 12312381 | Other | May. 22, 2045Active | Discovered |
| 12290666 | Other | May. 1, 2045Active | Discovered |
| 12269843 | Other | Apr. 3, 2045Active | Discovered |
| 12195779 | Other | Jan. 9, 2045Active | Discovered |
| 12178873 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12029882 | Other | Jul. 4, 2044Active | Discovered |
| 11993663 | Formulation/compound | May. 23, 2044Active | Discovered |
| 11944798 | Other | Mar. 28, 2044Active | Discovered |
| 11904143 | Other | Feb. 15, 2044Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11738138 | Other | Aug. 24, 2043Active | Discovered |
| 11576856 | 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 53 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.