ASPARAGINASE | B101063 | MERCK
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Jan. 10, 1978 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.
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 12441992(composition)· AI-discovered, not Purple-Book-listed · relevance 92/100. This caps practical skinny-label entry; it does not move the licensure floor above.
16 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 2 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12441992 | Formulation/compound | Oct. 9, 2045Active | Discovered |
| 12343387 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12121571 | Formulation/compound | Oct. 17, 2044Active | Discovered |
| 11802279 | Formulation/compound | Oct. 26, 2043Active | Discovered |
| 11504418 | Formulation/compound | Nov. 17, 2042Active | Discovered |
| 11141468 | Method-of-use (carveable) | Oct. 7, 2041Active | Discovered |
| 11046946 | Formulation/compound | Jun. 24, 2041Active | Discovered |
| 10174302 | Formulation/compound | Jan. 3, 2039Active | Discovered |
| 9920311 | Formulation/compound | Mar. 15, 2038Active | Discovered |
| 9789170 | Formulation/compound | Oct. 12, 2037Active | Discovered |
| 9731028 | Method-of-use (carveable) | Aug. 10, 2037Active | Discovered |
| 9353366 | Formulation/compound | May. 26, 2036Active | Discovered |
| 9333268 | Formulation/compound | May. 5, 2036Active | Discovered |
| 9181552 | Method-of-use (carveable) | Nov. 5, 2035Active | Discovered |
| 9051561 | Formulation/compound | Jun. 4, 2035Active | Discovered |
Showing 15 of 23 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.
23 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.