Orange Book product · Brand (NDA)

DURYSTA

BIMATOPROST

Brand (NDA)NDA 211911RX ABBVIE

Mar 04, 2020

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 04, 2020
6 yr 5 mo ago
Today
Patent 10441543 expires
Listed drug product patent expiration.
Dec 19, 2026
in 6 mo
Patent 9149428 expires
Listed drug product patent expiration.
Dec 19, 2026
in 6 mo
Patent 8206737 expires
Listed method-of-use patent (U-2759) expiration.
Apr 07, 2027
in 10 mo
Patent 7799336 expires
Listed drug product patent expiration.
Apr 24, 2029
in 2 yr 11 mo
Patent 8629185 expires
Listed drug substance patent expiration.
Jul 15, 2031
in 5 yr 2 mo
Patent 9492316 expires
Listed drug product patent expiration.
Oct 31, 2034
in 8 yr 6 mo
Patent 9980974 expires
Listed method-of-use patent (U-2759) expiration.
Oct 31, 2034
in 8 yr 6 mo

Active ingredient

BIMATOPROST

Strength

10MCG

Dosage form

IMPLANT

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 211911

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
10441543	Dec 19, 2026	in 6 mo	Product
9149428	Dec 19, 2026	in 6 mo	Product
8206737	Apr 07, 2027	in 10 mo	U-2759
7799336	Apr 24, 2029	in 2 yr 11 mo	Product
8629185	Jul 15, 2031	in 5 yr 2 mo	SubstanceProduct
9492316	Oct 31, 2034	in 8 yr 6 mo	Product
9980974	Oct 31, 2034	in 8 yr 6 mo	U-2759