cyclosporine · CYCLOSPORINE 1 mg/mL · Emulsion · Ophthalmic; Topical · Harrow Eye, LLC
NDC 82667-0014-00 · 5 POUCH in 1 CARTON / 5 VIAL, SINGLE-DOSE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →
12 companies supply this market — deep enough that no single failure threatens the supply. One of its named manufacturing plants, Excelvision, 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 82667-0014-01) — 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 1 quarter 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.
OAI inspection at a producing facility (24 months) · sole-source market
For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.
Backtested statistical model over the whole market, not this package alone. Model details →
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 |
|---|---|---|
| exclusivity | ODE-358 | Jun 23, 2028 |
| patent | 9132071 | Jun 2, 2029 |
| patent | 8298568 | Nov 3, 2027 |
| patent | 7973081 | Jan 27, 2026 |
| patent | 8524779 | Jan 27, 2026 |
| patent | 9956289 | Jan 27, 2026 |
| patent | 9220694 | Jan 27, 2026 |
| patent | 11612658 | Jan 27, 2026 |
No FDA shortage reports for this drug or its presentations.
No enforcement reports list this package NDC.
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Allergan, Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 3, 2026 |
| A-S Medication Solutions | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Apotex Corp | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Devatis Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Harrow Eye, LLC | CYCLOSPORINE 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Kvk-Tech, Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Lupin Pharmaceuticals, Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Mylan Pharmaceuticals Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Santen Incorporated | CYCLOSPORINE 1 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Saptalis Pharmaceuticals, LLC | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Teva Pharmaceuticals, Inc. | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Upsher-Smith Laboratories, LLC | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
| Amneal Pharmaceuticals NY LLC | CYCLOSPORINE .5 mg/mL | Jul 15, 2026 | Jul 22, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
DrugDashboards, "Verkazia — NDC 82667-0014-00," retrieved September 3, 2026, https://drugdashboards.com/drug/82667001400.
Free to cite with attribution — see how the data is put together.