RETEPLASE | B103786 | EKR THERAP
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Oct. 30, 1996 — 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 12303483(formulation)· AI-discovered, not Purple-Book-listed · relevance 55/100. This caps practical skinny-label entry; it does not move the licensure floor above.
7 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 20 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12391769 | Other | Aug. 14, 2045Active | Discovered |
| 12338456 | Other | Jun. 19, 2045Active | Discovered |
| 12303483 | Formulation/compound | May. 15, 2045Active | Discovered |
| 12036384 | Method-of-use (carveable) | Jul. 11, 2044Active | Discovered |
| 11865177 | Formulation/compound | Jan. 4, 2044Active | Discovered |
| 11844766 | Formulation/compound | Dec. 14, 2043Active | Discovered |
| 11639395 | Other | Apr. 27, 2043Active | Discovered |
| 11591382 | Other | Feb. 23, 2043Active | Discovered |
| 11078294 | Other | Jul. 29, 2041Active | Discovered |
| 11028149 | Other | Jun. 3, 2041Active | Discovered |
| 10816477 | Other | Oct. 22, 2040Active | Discovered |
| 10723762 | Other | Jul. 23, 2040Active | Discovered |
| 10501491 | Other | Dec. 5, 2039Active | Discovered |
| 10421950 | Other | Sep. 19, 2039Active | Discovered |
| 9889253 | Other | Feb. 8, 2038Active | Discovered |
Showing 15 of 30 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.
30 AI-discovered patents, sorted by relevance.
No patent or exclusivity listings for this strength.