Is there a generic for Bimatoprost?

Yes. The FDA Orange Book lists 15 approved generic (ANDA) applications for Bimatoprost, referencing the brand ZOLYMBUS. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bimatoprost?

ZOLYMBUS (NDA 217307, THEA PHARMA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Bimatoprost?

The Orange Book lists 9 patents against Bimatoprost products, with the earliest listed expiry in 2026. 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.

Does Bimatoprost have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Bimatoprost. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Bimatoprost are approved?

Bimatoprost is approved in the following dosage forms: gel, implant, solution/drops.

FDA Orange Book · active-ingredient family

Bimatoprost

Bimatoprost: 5 brands, 15 generics; first approved Mar 16, 2001; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 15 ANDA applications approved.

Earliest patent expiry Dec 19, 2026Latest exclusivity ends Sep 09, 2028

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Dec 19, 2026

in 4 mo

Brand (NDA) products

Originator applications

ZOLYMBUSRLDRS
THEA PHARMANDA 2173072025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% GEL OPHTHALMIC Rx —
DURYSTARLDRS
ABBVIENDA 2119112020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10MCG IMPLANT OPHTHALMIC Rx —
LUMIGANRLDRS
ABBVIENDA 0221842010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION/DROPS OPHTHALMIC Rx AB
LATISSERLDRS
ABBVIENDA 0223692008
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS TOPICAL Rx AT
LUMIGANRLD
ABBVIENDA 0212752001
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	GEL	OPHTHALMIC	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10MCG	IMPLANT	OPHTHALMIC	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Generic (ANDA) products (15)

Abbreviated applications

BIMATOPROST
AMNEALANDA 2172892025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION/DROPS OPHTHALMIC Rx AB
BIMATOPROST
MANKIND PHARMAANDA 2181962025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.01% SOLUTION/DROPS OPHTHALMIC Rx AB
BIMATOPROST
EUGIA PHARMAANDA 2055372022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
MICRO LABSANDA 2025052020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
ALEMBICANDA 2105152020
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS TOPICAL Rx AT
BIMATOPROST
SOMERSET THERAPS LLCANDA 2076012019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROSTRS
ALEMBICANDA 2102632019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
GLANDANDA 2101262019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
HIKMAANDA 2032992018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Discontinued —
BIMATOPROST
HIKMAANDA 2030512018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS TOPICAL Discontinued —
BIMATOPROST
SANDOZANDA 2027192016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS TOPICAL Rx AT
BIMATOPROST
APOTEXANDA 0904492015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
SANDOZANDA 2025652015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Rx AT
BIMATOPROST
LUPINANDA 2039912015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS OPHTHALMIC Discontinued —
BIMATOPROST
APOTEXANDA 2018942014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.03% SOLUTION/DROPS TOPICAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.01%	SOLUTION/DROPS	OPHTHALMIC	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	TOPICAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	TOPICAL	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Rx	AT

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	OPHTHALMIC	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.03%	SOLUTION/DROPS	TOPICAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NDFNew dosage form exclusivity (3 years)
Sep 09, 2028
in 2 yr 1 mo

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
10441543	Dec 19, 2026	in 4 mo	Product
9149428	Dec 19, 2026	in 4 mo	Product
8206737	Apr 07, 2027	in 8 mo	U-2759
7851504	Jun 13, 2027	in 10 mo	SubstanceProduct
7799336	Apr 24, 2029	in 2 yr 9 mo	Product
8629185	Jul 15, 2031	in 5 yr	SubstanceProduct
9980974	Oct 31, 2034	in 8 yr 4 mo	U-2759
9492316	Oct 31, 2034	in 8 yr 4 mo	Product
10314780	Jun 08, 2036	in 9 yr 11 mo	ProductU-1295

Approval history

FDA approval span

First approval

Mar 16, 2001

25 yr 10 mo ago

Most recent approval

Sep 22, 2025

11 mo ago

Approvals span 2001–2025 across 20 FDA applications.

Brand (NDA) 525%

Generic (ANDA) 1575%

Bimatoprost: 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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