Orange Book product · Brand (NDA)

VERKAZIA

CYCLOSPORINE

Brand (NDA)NDA 214965RX HARROW EYE

Jun 23, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 23, 2021
5 yr 1 mo ago
Patent 11612658 expires
Listed method-of-use patent (U-3560) expiration.
Jan 27, 2026
5 mo ago
Patent 7973081 expires
Listed drug product patent expiration.
Jan 27, 2026
5 mo ago
Patent 8524779 expires
Listed drug product patent expiration.
Jan 27, 2026
5 mo ago
Patent 9220694 expires
Listed drug product patent expiration.
Jan 27, 2026
5 mo ago
Patent 9956289 expires
Listed drug product patent expiration.
Jan 27, 2026
5 mo ago
Today
Patent 8298568 expires
Listed drug product patent expiration.
Nov 03, 2027
in 1 yr 5 mo
Exclusivity ends · ODE-358
Orphan-drug exclusivity (7 years)
Jun 23, 2028
in 2 yr 1 mo
Patent 9132071 expires
Listed drug product patent expiration.
Jun 02, 2029
in 3 yr

Active ingredient

CYCLOSPORINE

Strength

0.1%

Dosage form

EMULSION

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 214965

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11612658	Jan 27, 2026	5 mo ago	U-3560
7973081	Jan 27, 2026	5 mo ago	Product
8524779	Jan 27, 2026	5 mo ago	Product
9220694	Jan 27, 2026	5 mo ago	Product
9956289	Jan 27, 2026	5 mo ago	Product
8298568	Nov 03, 2027	in 1 yr 5 mo	Product
9132071	Jun 02, 2029	in 3 yr	Product