duvelisib · DUVELISIB 15 mg/1 · Capsule · Oral · Secura Bio, Inc
NDC 73116-0215-28 · 28 CAPSULE in 1 PACKAGE · NDA · View full market →
Just 2 companies supply this market — thin enough that a single exit would be felt immediately. One of its named manufacturing plants, Curia New York, Inc., failed FDA inspectionwithin the last two years — the agency’s most serious outcome.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Matched to CMS's representative package for this drug (NDC 73116-0215-56) — same generic, strength, and dosage form. CMS prices one NDC per drug concept, not every package.
Negotiated 30-day point-of-sale unit prices and formulary terms aggregated across every unsuppressed Part D and MA-PD plan for the quarter shown. Point of sale means gross of confidential rebates. CMS publishes one representative NDC per drug concept (RxCUI) rather than every package, so these figures come from CMS's representative package for the same drug — matched on generic name, strength, and dosage form. Estimated from MedPAC's program-wide rebate aggregates (June 2023: DIR = 29% of gross Part D spending; brand rebates ≈ 25–40% of gross, generics minimal). Actual rebates are confidential and vary widely by drug — this is a range, not a fact about this drug.
Pipeline and calculations built by Claude (Fable 5) from the public datasets above. Educational only — verify against primary sources before acting.
*No drug-level rebate is public — the estimate applies MedPAC's program-wide brand rebate range to this drug's gross price. Tracked here for 10 quarters since 2024.
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Not scored — fragility is computed for NADAC-priced NDCs.
Establishments this product's FDA label declares, located via FDA registration data. How we built this →
There's no legal definition — it meets 2 of 6 public criteria. Why that matters →
| Type | Number / code | Expires |
|---|---|---|
| patent | 12213983 | Apr 26, 2035 |
| patent | 12213983 | Apr 26, 2035 |
| patent | 8193182 | Sep 24, 2032 |
| patent | 8193182 | Sep 24, 2032 |
| patent | RE46621 | May 17, 2032 |
| patent | RE46621 | May 17, 2032 |
| patent | 11312718 | Jan 10, 2032 |
| patent | 9840505 | Jan 10, 2032 |
| patent | 9840505 | Jan 10, 2032 |
| patent | 11312718 | Jan 10, 2032 |
| patent | 9216982 | Jan 5, 2029 |
| patent | 9216982 | Jan 5, 2029 |
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Catalent Pharma Solutions, LLC | DUVELISIB 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Catalent Pharma Solutions, LLC | DUVELISIB 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Secura Bio, Inc | DUVELISIB 15 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
| Secura Bio, Inc | DUVELISIB 25 mg/1 | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
DrugDashboards, "Copiktra — NDC 73116-0215-28," retrieved September 3, 2026, https://drugdashboards.com/drug/73116021528.
Free to cite with attribution — see how the data is put together.