The short version
Only one company currently supplies this market — there is no backup if it stumbles.
The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.
Cequa
cyclosporine · CYCLOSPORINE .0009 mg/mL · Solution/ Drops · Ophthalmic; Topical · Sun Pharmaceutical Industries, Inc.
NDC 47335-0507-97 · 1 POUCH in 1 BOX / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE · NDA · View full market →
Medicare Part D
No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.
How Part D pricing works →NADAC price per unit
No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.
Supply fragility
Not scored — fragility is computed for NADAC-priced NDCs.
90-day shortage risk (model v2)
0.1%chance of a new FDA shortage posting for cyclosporine (other) in the next 90 days
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 →
Regulatory
- Application
- NDA210913
- TE code
- —
- Approval date
- Aug 14, 2018
- Patents / exclusivity
- 5 patents, 0 exclusivities
| Type | Number / code | Expires |
|---|---|---|
| patent | 11951153 | Feb 28, 2037 |
| patent | 10918694 | Feb 28, 2037 |
| patent | 8980839 | Aug 23, 2033 |
| patent | 9937225 | Aug 23, 2033 |
| patent | 10441630 | Aug 23, 2033 |
Shortage history
No FDA shortage reports for this drug or its presentations.
Recalls (this NDC)
- Class III · TerminatedSep 7, 2023SUN PHARMACEUTICAL INDUSTRIES INC — Subpotent: Out of Specification result observed for low assay
- Class III · TerminatedApr 1, 2022SUN PHARMACEUTICAL INDUSTRIES INC — Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
- Class III · TerminatedMay 7, 2021SUN PHARMACEUTICAL INDUSTRIES INC — Subpotent and Presence of Particulates .
- Class III · TerminatedFeb 22, 2021SUN PHARMACEUTICAL INDUSTRIES INC — Subpotent
Manufacturers of cyclosporine (Solution/ Drops)
| Labeler | Strength | First seen | Last seen |
|---|---|---|---|
| Sun Pharmaceutical Industries, Inc. | CYCLOSPORINE .0009 g/mL | Jul 15, 2026 | Sep 2, 2026 |
| Sun Pharmaceutical Industries, Inc. | CYCLOSPORINE .0009 mg/mL | Jul 15, 2026 | Sep 2, 2026 |
Roster from daily NDC Directory diffs — first/last seen dates start July 2026.
Cite this page
DrugDashboards, "Cequa — NDC 47335-0507-97," retrieved September 3, 2026, https://drugdashboards.com/drug/47335050797.
Free to cite with attribution — see how the data is put together.