FDA Orange Book
Generic for Zyclara
Zyclara contains imiquimod. 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
Yes. The generic name for Zyclara is imiquimod. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Zyclara products the Orange Book lists.
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Zyclara products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 2.5% | Marketed (Rx) | None | 0 | None |
| cream, topical | 3.75% | Marketed (Rx) | AB | 1 | AB |
NDA 022483, held by BAUSCH HEALTH US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic imiquimod
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TARO PHARMACEUTICAL INDUSTRIES LTD | 205971 | AB (A-rated, therapeutically equivalent) | January 26, 2021 | 3.75% |
Zyclara patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10238645 | August 18, 2029 | Method of use | U-172 | 022483 |
| 10238645 | August 18, 2029 | Method of use | U-1455 | 022483 |
| 8598196 | August 18, 2029 | Method of use | U-172 | 022483 |
| 8598196 | August 18, 2029 | Method of use | U-1455 | 022483 |
| 8222270 | December 11, 2029 | Method of use | U-68 | 022483 |
| 11318130 | December 11, 2029 | Method of use | U-68 | 022483 |
| 8236816 | December 11, 2029 | Method of use | U-68 | 022483 |
| 8299109 | December 11, 2029 | Method of use | U-68 | 022483 |
| 10238644 | December 11, 2029 | Method of use | U-68 | 022483 |
| 11202752 | April 30, 2030 | Method of use | U-1455 | 022483 |
| 11202752 | April 30, 2030 | Method of use | U-172 | 022483 |
| 11850245 | April 30, 2030 | Method of use | U-1455 | 022483 |
| 11850245 | April 30, 2030 | Method of use | U-172 | 022483 |
| 10918635 | April 30, 2030 | Method of use | U-172 | 022483 |
| 10918635 | April 30, 2030 | Method of use | U-1455 | 022483 |
Zyclara NDC codes
Questions
Is there a generic for Zyclara?
Yes. The generic name for Zyclara is imiquimod. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Zyclara products the Orange Book lists.
What is the generic name for Zyclara?
The active ingredient in Zyclara is imiquimod, per the FDA Orange Book.
When does the Zyclara patent expire?
The last patent listed for Zyclara in the Orange Book expires April 30, 2030. 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.