ALEMTUZUMAB | B103948 | GENZYME
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved May. 7, 2001 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
Full-label vs. best-skinny biosimilar entry
| Scenario | Date | Status | Controlling |
|---|---|---|---|
| Best-skinny entry (floor) | Open now | Open now | no live licensure floor |
| Full-label entry | May. 7, 2008 | Passed | no live block |
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 12384852(composition)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
26 formulation/compound (cap skinny entry) · 12 method-of-use (carveable — gate nothing) · 12 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12384852 | Formulation/compound | Aug. 7, 2045Active | Discovered |
| 12377164 | Formulation/compound | Jul. 31, 2045Active | Discovered |
| 12337038 | Formulation/compound | Jun. 19, 2045Active | Discovered |
| 12178876 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 11945874 | Formulation/compound | Mar. 28, 2044Active | Discovered |
| 11919925 | Other | Feb. 29, 2044Active | Discovered |
| 11865175 | Method-of-use (carveable) | Jan. 4, 2044Active | Discovered |
| 11672802 | Method-of-use (carveable) | Jun. 8, 2043Active | Discovered |
| 11370801 | Formulation/compound | Jun. 23, 2042Active | Discovered |
| 11242382 | Formulation/compound | Feb. 3, 2042Active | Discovered |
| 11243211 | Method-of-use (carveable) | Feb. 3, 2042Active | Discovered |
| 11236126 | Other | Jan. 27, 2042Active | Discovered |
| 11215623 | Other | Dec. 30, 2041Active | Discovered |
| 11020430 | Method-of-use (carveable) | May. 27, 2041Active | Discovered |
| 10961585 | Other | Mar. 25, 2041Active | Discovered |
Showing 15 of 50 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.
Top 50 of 87 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.