ROMIPLOSTIM | B125268 | AMGEN
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Aug. 22, 2008 — 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 | Jan. 28, 2028 | 1y 6mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])", protected through 2028-01-28) advances biosimilar entry from the full-label date to now (no remaining licensure floor).
Carve frontier · drop each orphan-walled indication to advance entry
| Drop this orphan-walled indication | Walled through | → Entry advances to |
|---|---|---|
| to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])(label indication #3) | Jan. 28, 2028 | Oct. 17, 2026(next orphan wall) |
| For the treatment of thrombocytopenia in adult patients with non-chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.(label indication #1) | Oct. 17, 2026 | Open now(12-yr RPE floor) |
Each rung drops one orphan-designated indication (sourced from the FDA Orphan Drug Product designation database and matched to the reference label); dropping the latest-walled indication advances biosimilar entry to the next constraint, until every orphan wall is carved and entry reaches the RPE floor.
Carveable orphan wall · Jan. 28, 2028
Orphan-drug exclusivity runs past the licensure floor, but it walls only its specific orphan-designated indication(s). A biosimilar can omit those indications (a “fewer-than-all-conditions” carve-out) and be licensed for the rest now, then add the protected indication back by supplement once the orphan period expires. It is not a licensure gate for the other indications.
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 12251474(formulation)· AI-discovered, not Purple-Book-listed · relevance 75/100. This caps practical skinny-label entry; it does not move the licensure floor above.
28 formulation/compound (cap skinny entry) · 0 method-of-use (carveable — gate nothing) · 22 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12434015 | Other | Oct. 2, 2045Active | Discovered |
| 12350480 | Other | Jul. 3, 2045Active | Discovered |
| 12325737 | Other | Jun. 5, 2045Active | Discovered |
| 12251474 | Formulation/compound | Mar. 13, 2045Active | Discovered |
| 12178873 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12029882 | Other | Jul. 4, 2044Active | Discovered |
| 11944798 | Other | Mar. 28, 2044Active | Discovered |
| 11904143 | Other | Feb. 15, 2044Active | Discovered |
| 11813328 | Formulation/compound | Nov. 9, 2043Active | Discovered |
| 11672733 | Other | Jun. 8, 2043Active | Discovered |
| 11466078 | Formulation/compound | Oct. 6, 2042Active | Discovered |
| 11427627 | Formulation/compound | Aug. 25, 2042Active | Discovered |
| 11419990 | Other | Aug. 18, 2042Active | Discovered |
| 11389588 | Other | Jul. 14, 2042Active | Discovered |
| 11384140 | Other | Jul. 7, 2042Active | 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 55 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.