SOTATERCEPT-CSRK | B761363 | 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 (Mar. 26, 2024), 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) | Mar. 26, 2036 | 9y 8mo remaining | 12-year RPE floor (non-carveable) |
| Full-label entry | Mar. 26, 2036 | 9y 8mo 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 12344670· AI-discovered, not Purple-Book-listed · relevance 80/100. This caps practical skinny-label entry; it does not move the licensure floor above.
41 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 6 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12344670 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12343378 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12145970 | Formulation/compound | Nov. 14, 2044Active | Discovered |
| 12042524 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 11959118 | Formulation/compound | Apr. 11, 2044Active | Discovered |
| 11884724 | Formulation/compound | Jan. 25, 2044Active | Discovered |
| 11406706 | Formulation/compound | Aug. 4, 2042Active | Discovered |
| 11292848 | Formulation/compound | Mar. 31, 2042Active | Discovered |
| 11001640 | Formulation/compound | May. 6, 2041Active | Discovered |
| 10982008 | Formulation/compound | Apr. 15, 2041Active | Discovered |
| 10772947 | Formulation/compound | Sep. 10, 2040Active | Discovered |
| 10759856 | Formulation/compound | Aug. 27, 2040Active | Discovered |
| 10640559 | Formulation/compound | Apr. 30, 2040Active | Discovered |
| 10487147 | Formulation/compound | Nov. 21, 2039Active | Discovered |
| 10369213 | Other | Aug. 1, 2039Active | 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 209 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.