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
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, ophthalmic | 0.01% | Marketed (Rx) | None | 0 | None |
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
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10314780 | June 8, 2036 | Drug product | U-1295 | 217307 |
Zolymbus exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NDF | See the Orange Book exclusivity code list | September 9, 2028 | 217307 |
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.
More on Zolymbus and Bimatoprost
- What is Bimatoprost used for?FDA label uses
- Is Bimatoprost a controlled substance?Federal schedule
- Generic for DurystaFDA Orange Book
- Generic for LumiganFDA Orange Book
- Generic for LatisseFDA Orange Book
- Prostaglandin Analogs listFDA drug class
- Zolymbus Medicare Part D coverageBy plan and state
- NDC 82584-010Zolymbus NDC record