RILONACEPT | B125249 | KINIKSA PHARMACEUTICALS (UK), LTD.
No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Feb. 27, 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 | Mar. 18, 2028 | 1y 8mo remaining | carveable orphan wall |
Minimal carve: Dropping the orphan-walled indication ("Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older", protected through 2028-03-18) 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 recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older(label indication #5) | Mar. 18, 2028 | 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 · Mar. 18, 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 12403181(composition)· AI-discovered, not Purple-Book-listed · relevance 85/100. This caps practical skinny-label entry; it does not move the licensure floor above.
22 formulation/compound (cap skinny entry) · 13 method-of-use (carveable — gate nothing) · 15 device/diagnostic/manufacturing
| Patent | Class | Expiration | Source |
|---|---|---|---|
| 12411141 | Other | Sep. 4, 2045Active | Discovered |
| 12403181 | Formulation/compound | Aug. 28, 2045Active | Discovered |
| 12291563 | Other | May. 1, 2045Active | Discovered |
| 12180272 | Formulation/compound | Dec. 26, 2044Active | Discovered |
| 12174173 | Other | Dec. 19, 2044Active | Discovered |
| 12117452 | Other | Oct. 10, 2044Active | Discovered |
| 12055551 | Other | Aug. 1, 2044Active | Discovered |
| 12054751 | Other | Aug. 1, 2044Active | Discovered |
| 11885811 | Other | Jan. 25, 2044Active | Discovered |
| 11795217 | Method-of-use (carveable) | Oct. 19, 2043Active | Discovered |
| 11713922 | Formulation/compound | Jul. 27, 2043Active | Discovered |
| 11708407 | Formulation/compound | Jul. 20, 2043Active | Discovered |
| 11525629 | Formulation/compound | Dec. 8, 2042Active | Discovered |
| 11525823 | Other | Dec. 8, 2042Active | Discovered |
| 11518807 | Formulation/compound | Dec. 1, 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 67 AI-discovered patents by relevance.
No patent or exclusivity listings for this strength.