Is there a generic for Brimonidine tartrate?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Brimonidine tartrate, referencing the brand LUMIFY PRESERVATIVE FREE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Brimonidine tartrate?

LUMIFY PRESERVATIVE FREE (NDA 218424, BAUSCH AND LOMB INC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Brimonidine tartrate?

The Orange Book lists 11 patents against Brimonidine tartrate products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Brimonidine tartrate are approved?

Brimonidine tartrate is approved in the following dosage forms: gel, solution/drops.

FDA Orange Book · active-ingredient family

Brimonidine tartrate

Brimonidine tartrate: 8 brands, 22 generics; first approved Sep 06, 1996; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 22 ANDA applications approved.

Earliest patent expiry Jul 27, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 27, 2029

in 3 yr

Brand (NDA) products

Originator applications

LUMIFY PRESERVATIVE FREERLDRS
BAUSCH AND LOMB INCNDA 2184242024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% SOLUTION/DROPS OPHTHALMIC OTC —
LUMIFYRLDRS
BAUSCH AND LOMB INCNDA 2081442017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% SOLUTION/DROPS OPHTHALMIC OTC —
MIRVASORLDRS
GALDERMA LABS LPNDA 2047082013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.33% BASE GEL TOPICAL Rx AB
QOLIANARLDRS
SANDOZNDA 0217642006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% SOLUTION/DROPS OPHTHALMIC Rx AT
ALPHAGAN PRLDRS
ABBVIENDA 0217702005
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
ALPHAGAN PRLDRS
ABBVIENDA 0212622001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% SOLUTION/DROPS OPHTHALMIC Rx AT
ALPHAGANRLD
ALLERGANNDA 0206131996
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Discontinued —
ALPHAGAN
ALLERGANNDA 0204901997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5% SOLUTION/DROPS OPHTHALMIC Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.33% BASE	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Generic (ANDA) products (22)

Abbreviated applications

BRIMONIDINE TARTRATE
MICRO LABSANDA 2185582026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
MANKIND PHARMAANDA 2203982026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
GLANDANDA 2192192026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
UPSHER SMITH LABSANDA 2175992025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Discontinued —
BRIMONIDINE TARTRATE
LUPINANDA 2132152024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
SOMERSET THERAPS LLCANDA 2169062024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
UPSHER SMITH LABSANDA 2167722024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% SOLUTION/DROPS OPHTHALMIC Discontinued —
BRIMONIDINE TARTRATE
SANDOZANDA 2031722024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
DR REDDYS LABS SAANDA 2163612024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.025% SOLUTION/DROPS OPHTHALMIC OTC —
BRIMONIDINE TARTRATE
MICRO LABSANDA 2178462023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
ALEMBICANDA 2169092023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
ALEMBICANDA 2152252023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
APOTEXANDA 0784802022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1% SOLUTION/DROPS OPHTHALMIC Rx AB
BRIMONIDINE TARTRATE
APOTEXANDA 0784792022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.15% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
PADAGIS ISRAELANDA 2091582021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 0.33% BASE GEL TOPICAL Rx AB
BRIMONIDINE TARTRATE
SOMERSET THERAPS LLCANDA 2089922019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
REGCON HOLDINGSANDA 0916912014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
SANDOZANDA 0780752008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
RISINGANDA 0764392006
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATE
TEVA PARENTERALANDA 0763722004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Discontinued —
BRIMONIDINE TARTRATE
SANDOZANDA 0762542003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT
BRIMONIDINE TARTRATERS
BAUSCH AND LOMB INCANDA 0762602003
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2% SOLUTION/DROPS OPHTHALMIC Rx AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.025%	SOLUTION/DROPS	OPHTHALMIC	OTC	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.15%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 0.33% BASE	GEL	TOPICAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

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	U-2222
11833245	Jul 27, 2029	in 3 yr	U-2222
8293742	Jul 14, 2030	in 3 yr 11 mo	U-2222
9259425	Jul 14, 2030	in 3 yr 11 mo	U-2222
8513247	Mar 25, 2031	in 4 yr 8 mo	ProductU-1428
8513249	Mar 25, 2031	in 4 yr 8 mo	ProductU-1428
9861631	Mar 25, 2031	in 4 yr 8 mo	U-1428
9861632	Mar 25, 2031	in 4 yr 8 mo	U-1428
8053427	Jun 13, 2031	in 4 yr 11 mo	ProductU-1428
8163725	Jun 13, 2031	in 4 yr 11 mo	Product
10201517	Jun 13, 2031	in 4 yr 11 mo	Product

Approval history

FDA approval span

First approval

Sep 06, 1996

30 yr 5 mo ago

Most recent approval

May 07, 2026

4 mo ago

Approvals span 1996–2026 across 30 FDA applications.

Brand (NDA) 827%

Generic (ANDA) 2273%

Brimonidine tartrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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