BEZLOTOXUMAB | B761046 | MERCK SHARP DOHME
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 (Oct. 21, 2016), 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) | Oct. 21, 2028 | 2y 3mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Oct. 21, 2028 | 2y 3mo 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 12358944· AI-discovered, not Purple-Book-listed · relevance 52/100. This caps practical skinny-label entry; it does not move the licensure floor above.
33 formulation/compound (cap skinny entry) · 4 method-of-use (carveable — gate nothing) · 13 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12385913 | Other | Aug. 7, 2045Active | Discovered |
| 12358944 | Formulation/compound | Jul. 10, 2045Active | Discovered |
| 12350340 | Formulation/compound | Jul. 3, 2045Active | Discovered |
| 12325875 | Other | Jun. 5, 2045Active | Discovered |
| 12234483 | Other | Feb. 20, 2045Active | Discovered |
| 12157073 | Other | Nov. 28, 2044Active | Discovered |
| 12103949 | Other | Sep. 26, 2044Active | Discovered |
| 12071666 | Formulation/compound | Aug. 22, 2044Active | Discovered |
| 12042524 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 12030923 | Formulation/compound | Jul. 4, 2044Active | Discovered |
| 11952420 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11952421 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11919954 | Formulation/compound | Feb. 29, 2044Active | Discovered |
| 11866505 | Formulation/compound | Jan. 4, 2044Active | Discovered |
| 11666611 | Formulation/compound | Jun. 1, 2043Active | 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 60 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.