Orange Book product · Brand (NDA)

LUMIFY PRESERVATIVE FREE

BRIMONIDINE TARTRATE

Brand (NDA)NDA 218424OTC BAUSCH AND LOMB INC

Apr 19, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 19, 2024
2 yr 2 mo ago
Today
Patent 11596600 expires
Listed method-of-use patent (U-2222) expiration.
Jul 27, 2029
in 3 yr 2 mo
Patent 8293742 expires
Listed method-of-use patent (U-2222) expiration.
Jul 14, 2030
in 4 yr 2 mo
Patent 9259425 expires
Listed method-of-use patent (U-2222) expiration.
Jul 14, 2030
in 4 yr 2 mo

Active ingredient

BRIMONIDINE TARTRATE

Strength

0.025%

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 218424

Product number

001

Marketing status

OTC

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
11596600	Jul 27, 2029	in 3 yr 2 mo	U-2222
8293742	Jul 14, 2030	in 4 yr 2 mo	U-2222
9259425	Jul 14, 2030	in 4 yr 2 mo	U-2222