Orange Book product · Brand (NDA)

DEXYCU KIT

DEXAMETHASONE

Brand (NDA)NDA 208912RX EYEPOINT PHARMS

Feb 09, 2018

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 09, 2018
8 yr 6 mo ago
Today
Patent 10799642 expires
Listed drug product patent expiration.
May 11, 2032
in 6 yr
Patent 10028965 expires
Listed method-of-use patent (U-2340) expiration.
May 23, 2034
in 8 yr 1 mo
Patent 10159683 expires
Listed drug product patent expiration.
May 23, 2034
in 8 yr 1 mo
Patent 10022502 expires
Listed method-of-use patent (U-2340) expiration.
Jun 22, 2034
in 8 yr 2 mo
Patent 11097061 expires
Listed drug product patent expiration.
Jun 23, 2039
in 13 yr 2 mo

Active ingredient

DEXAMETHASONE

Strength

Dosage form

SUSPENSION

Route

INTRAOCULAR

TE code

Not listed

Application

NDA 208912

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
10799642	May 11, 2032	in 6 yr	Product
10028965	May 23, 2034	in 8 yr 1 mo	U-2340
10159683	May 23, 2034	in 8 yr 1 mo	Product
10022502	Jun 22, 2034	in 8 yr 2 mo	U-2340
11097061	Jun 23, 2039	in 13 yr 2 mo	ProductU-3418