FDA Orange Book
Is there a generic for Arazlo?
Arazlo contains tazarotene. 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 Arazlo (tazarotene). The Orange Book shows its last listed patent expires May 11, 2038.
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Arazlo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.045% | Marketed (Rx) | None | 0 | None |
NDA 211882, 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.
Arazlo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11679116 | June 6, 2036 | Drug product | None | 211882 |
| 11311482 | May 11, 2038 | Method of use | U-2368 | 211882 |
| 12128137 | May 11, 2038 | Drug product | U-2368 | 211882 |
Arazlo NDC codes
Questions
Is there a generic for Arazlo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Arazlo (tazarotene). The Orange Book shows its last listed patent expires May 11, 2038.
What is the generic name for Arazlo?
The active ingredient in Arazlo is tazarotene, per the FDA Orange Book.
When does the Arazlo patent expire?
The last patent listed for Arazlo in the Orange Book expires May 11, 2038. 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.