Orange Book product · Brand (NDA)

MIRVASO

BRIMONIDINE TARTRATE

Brand (NDA)NDA 204708TE ABRX GALDERMA LABS LP

Aug 23, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 23, 2013
13 yr ago
Today
Patent 8513247 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 8513249 expires
Listed drug product patent expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 9861631 expires
Listed method-of-use patent (U-1428) expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 9861632 expires
Listed method-of-use patent (U-1428) expiration.
Mar 25, 2031
in 4 yr 10 mo
Patent 10201517 expires
Listed drug product patent expiration.
Jun 13, 2031
in 5 yr 1 mo
Patent 8053427 expires
Listed drug product patent expiration.
Jun 13, 2031
in 5 yr 1 mo
Patent 8163725 expires
Listed drug product patent expiration.
Jun 13, 2031
in 5 yr 1 mo

Active ingredient

BRIMONIDINE TARTRATE

Strength

EQ 0.33% BASE

Dosage form

GEL

Route

TOPICAL

TE code

Application

NDA 204708

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
8513247	Mar 25, 2031	in 4 yr 10 mo	ProductU-1428
8513249	Mar 25, 2031	in 4 yr 10 mo	ProductU-1428
9861631	Mar 25, 2031	in 4 yr 10 mo	U-1428
9861632	Mar 25, 2031	in 4 yr 10 mo	U-1428
10201517	Jun 13, 2031	in 5 yr 1 mo	Product
8053427	Jun 13, 2031	in 5 yr 1 mo	ProductU-1428
8163725	Jun 13, 2031	in 5 yr 1 mo	Product