NECITUMUMAB | B125547 | ELI LILLY CO
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. 24, 2015), 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. 24, 2027 | 1y 4mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Nov. 24, 2027 | 1y 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 12421294(composition)· AI-discovered, not Purple-Book-listed · relevance 68/100. This caps practical skinny-label entry; it does not move the licensure floor above.
18 formulation/compound (cap skinny entry) · 10 method-of-use (carveable — gate nothing) · 5 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421294 | Formulation/compound | Sep. 18, 2045Active | Discovered |
| 12201719 | Method-of-use (carveable) | Jan. 16, 2045Active | Discovered |
| 12098428 | Other | Sep. 19, 2044Active | Discovered |
| 12053491 | Formulation/compound | Aug. 1, 2044Active | Discovered |
| 11976136 | Formulation/compound | May. 2, 2044Active | Discovered |
| 11879012 | Method-of-use (carveable) | Jan. 18, 2044Active | Discovered |
| 11629193 | Formulation/compound | Apr. 13, 2043Active | Discovered |
| 11471457 | Method-of-use (carveable) | Oct. 13, 2042Active | Discovered |
| 11155783 | Formulation/compound | Oct. 21, 2041Active | Discovered |
| 11008620 | Method-of-use (carveable) | May. 13, 2041Active | Discovered |
| 10774156 | Formulation/compound | Sep. 10, 2040Active | Discovered |
| 10697022 | Other | Jun. 25, 2040Active | Discovered |
| 10391180 | Formulation/compound | Aug. 22, 2039Active | Discovered |
| 10294307 | Other | May. 16, 2039Active | Discovered |
| 10188728 | Formulation/compound | Jan. 24, 2039Active | Discovered |
Showing 15 of 33 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.
33 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.