FDA Orange Book

Is there a generic for Durysta?

Durysta contains bimatoprost. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.

Source: FDA Orange Book data file dated 2026-10-09. Publisher page

No. The Orange Book lists no active FDA-approved generic (ANDA) for Durysta (bimatoprost). The Orange Book shows its last listed patent expires October 31, 2034.

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Durysta products in the Orange Book

Durysta products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
implant, ophthalmic10MCGMarketed (Rx)None0None

NDA 211911, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Durysta patents

Patents listed for Durysta
PatentExpiresCoversUse codeNDA
10441543December 19, 2026Drug productNone211911
9149428December 19, 2026Drug productNone211911
8206737April 7, 2027Method of useU-2759211911
7799336April 24, 2029Drug productNone211911
8629185July 15, 2031Drug substance, Drug productNone211911
9980974October 31, 2034Method of useU-2759211911
9492316October 31, 2034Drug productNone211911

Durysta NDC codes

Questions

Is there a generic for Durysta?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Durysta (bimatoprost). The Orange Book shows its last listed patent expires October 31, 2034.

What is the generic name for Durysta?

The active ingredient in Durysta is bimatoprost, per the FDA Orange Book.

When does the Durysta patent expire?

The last patent listed for Durysta in the Orange Book expires October 31, 2034. A listed patent expiry date is not a generic launch date.

What does a therapeutic equivalence code mean?

In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.

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