Orange Book product · Brand (NDA)

CEQUA

CYCLOSPORINE

Brand (NDA)NDA 210913RX SUN PHARM

Aug 14, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 14, 2018
8 yr ago
Today
Patent 10441630 expires
Listed drug product patent expiration.
Aug 23, 2033
in 7 yr 3 mo
Patent 8980839 expires
Listed drug product patent expiration.
Aug 23, 2033
in 7 yr 3 mo
Patent 9937225 expires
Listed drug product patent expiration.
Aug 23, 2033
in 7 yr 3 mo
Patent 10918694 expires
Listed drug product patent expiration.
Feb 28, 2037
in 10 yr 10 mo
Patent 11951153 expires
Listed method-of-use patent (U-1483) expiration.
Feb 28, 2037
in 10 yr 10 mo

Active ingredient

CYCLOSPORINE

Strength

0.09%

Dosage form

SOLUTION

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 210913

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
10441630	Aug 23, 2033	in 7 yr 3 mo	Product
8980839	Aug 23, 2033	in 7 yr 3 mo	ProductU-1483
9937225	Aug 23, 2033	in 7 yr 3 mo	ProductU-1483
10918694	Feb 28, 2037	in 10 yr 10 mo	Product
11951153	Feb 28, 2037	in 10 yr 10 mo	U-1483