LUSPATERCEPT-AAMT | B761136 | CELGENE CORP
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Nov. 8, 2019 — 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 | Aug. 28, 2030 | 3y 9mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication(s) (protected through 2030-08-28) 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 |
|---|---|---|
| treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naive) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions(label indication #2) | Aug. 28, 2030 | Nov. 8, 2026(next orphan wall) |
| Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions.(label indication #1) | Nov. 8, 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 · Aug. 28, 2030
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 12421295(composition)· AI-discovered, not Purple-Book-listed · relevance 95/100. This caps practical skinny-label entry; it does not move the licensure floor above.
46 formulation/compound (cap skinny entry) · 3 method-of-use (carveable — gate nothing) · 1 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12421295 | Formulation/compound | Sep. 18, 2045Active | Discovered |
| 12343378 | Formulation/compound | Jun. 26, 2045Active | Discovered |
| 12240887 | Formulation/compound | Feb. 27, 2045Active | Discovered |
| 12168683 | Formulation/compound | Dec. 12, 2044Active | Discovered |
| 12145970 | Formulation/compound | Nov. 14, 2044Active | Discovered |
| 12103959 | Formulation/compound | Sep. 26, 2044Active | Discovered |
| 12042524 | Formulation/compound | Jul. 18, 2044Active | Discovered |
| 12030923 | Formulation/compound | Jul. 4, 2044Active | Discovered |
| 12024563 | Formulation/compound | Jun. 27, 2044Active | Discovered |
| 11951156 | Formulation/compound | Apr. 4, 2044Active | Discovered |
| 11318188 | Formulation/compound | Apr. 28, 2042Active | Discovered |
| 11219666 | Formulation/compound | Jan. 6, 2042Active | Discovered |
| 11021527 | Formulation/compound | May. 27, 2041Active | Discovered |
| 10981973 | Formulation/compound | Apr. 15, 2041Active | Discovered |
| 10973880 | Formulation/compound | Apr. 8, 2041Active | 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 82 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.