Orange Book product · Brand (NDA)

VEVYE

CYCLOSPORINE

Brand (NDA)NDA 217469RX HARROW EYE

May 30, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 30, 2023
3 yr 1 mo ago
Exclusivity ends · NP
New product exclusivity (3 years)
May 30, 2026
20 d ago
Today
Patent 8614178 expires
Listed drug product patent expiration.
Dec 13, 2030
in 4 yr 7 mo
Patent 12496326 expires
Listed method-of-use patent (U-3627) expiration.
Sep 29, 2036
in 10 yr 5 mo
Patent 10813976 expires
Listed drug product patent expiration.
Sep 22, 2037
in 11 yr 5 mo
Patent 11154513 expires
Listed drug product patent expiration.
Nov 20, 2038
in 12 yr 7 mo
Patent 11413323 expires
Listed method-of-use patent (U-3627) expiration.
Oct 11, 2039
in 13 yr 6 mo
Patent 12059449 expires
Listed drug product patent expiration.
Apr 01, 2042
in 16 yr

Active ingredient

CYCLOSPORINE

Strength

0.1%

Dosage form

SOLUTION

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 217469

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
8614178	Dec 13, 2030	in 4 yr 7 mo	Product
12496326	Sep 29, 2036	in 10 yr 5 mo	U-3627
10813976	Sep 22, 2037	in 11 yr 5 mo	Product
11154513	Nov 20, 2038	in 12 yr 7 mo	ProductU-1900
11413323	Oct 11, 2039	in 13 yr 6 mo	U-3627
12059449	Apr 01, 2042	in 16 yr	ProductU-1483