FDA Orange Book

Is there a generic for Zolymbus?

Zolymbus 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 Zolymbus (bimatoprost). The Orange Book shows its last listed patent expires June 8, 2036 and its last listed exclusivity ends September 9, 2028.

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Zolymbus products in the Orange Book

Zolymbus products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
gel, ophthalmic0.01%Marketed (Rx)None0None

NDA 217307, held by THEA PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Zolymbus patents

Patents listed for Zolymbus
PatentExpiresCoversUse codeNDA
10314780June 8, 2036Drug productU-1295217307

Zolymbus exclusivity

Exclusivity listed for Zolymbus
CodeMeaningExpiresNDA
NDFSee the Orange Book exclusivity code listSeptember 9, 2028217307

Zolymbus NDC codes

Questions

Is there a generic for Zolymbus?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Zolymbus (bimatoprost). The Orange Book shows its last listed patent expires June 8, 2036 and its last listed exclusivity ends September 9, 2028.

What is the generic name for Zolymbus?

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

When does the Zolymbus patent expire?

The last patent listed for Zolymbus in the Orange Book expires June 8, 2036. 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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