FDA Orange Book
Is there a generic for Zoryve?
Zoryve contains roflumilast. 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 Zoryve (roflumilast). The Orange Book shows its last listed patent expires August 19, 2042 and its last listed exclusivity ends June 29, 2029.
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Zoryve products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 0.05% | Marketed (Rx) | None | 0 | None |
| cream, topical | 0.15% | Marketed (Rx) | None | 0 | None |
| cream, topical | 0.3% | Marketed (Rx) | None | 0 | None |
| foam, topical | 0.3% | Marketed (Rx) | None | 0 | None |
NDA 215985, 217242, held by ARCUTIS BIOTHERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zoryve patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12005051 | June 7, 2037 | Method of use | U-3970 | 215985 |
| 11992480 | June 7, 2037 | Method of use | U-3970 | 215985 |
| 11819496 | June 7, 2037 | Method of use | U-3970 | 215985 |
| 12310956 | June 7, 2037 | Method of use | U-3970 | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-3970 | 215985 |
| 12042487 | June 7, 2037 | Drug product | None | 215985 |
| 12016848 | June 7, 2037 | Drug product | None | 215985 |
| 12336983 | June 7, 2037 | Drug product | None | 215985 |
| 12011437 | June 7, 2037 | Drug product | None | 215985 |
| 10940142 | June 7, 2037 | Drug product | None | 215985 |
| 12697329 | June 7, 2037 | Drug product | None | 215985 |
| 12005052 | June 7, 2037 | Drug product | None | 215985 |
| 12220409 | June 7, 2037 | Drug product | None | 215985 |
| 12257242 | June 7, 2037 | Drug product | None | 215985 |
| 9884050 | June 7, 2037 | Drug product | None | 215985 |
| 11793796 | June 7, 2037 | Drug product | None | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-3712 | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-3408 | 215985 |
| 11819496 | June 7, 2037 | Method of use | U-3748 | 215985 |
| 12310956 | June 7, 2037 | Method of use | U-4578 | 215985 |
| 12005051 | June 7, 2037 | Method of use | U-4578 | 215985 |
| 11992480 | June 7, 2037 | Method of use | U-4578 | 215985 |
| 11819496 | June 7, 2037 | Method of use | U-4578 | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-4578 | 215985 |
| 12310956 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 11992480 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 11819496 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 12005051 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 12685727 | June 7, 2037 | Method of use | U-4301 | 215985 |
| 9907788 | June 7, 2037 | Method of use | U-4203 | 217242 |
| 11819496 | June 7, 2037 | Method of use | U-4203 | 217242 |
| 11992480 | June 7, 2037 | Method of use | U-4203 | 217242 |
| 12005051 | June 7, 2037 | Method of use | U-4203 | 217242 |
| 12310956 | June 7, 2037 | Method of use | U-3773 | 217242 |
| 12310956 | June 7, 2037 | Method of use | U-4203 | 217242 |
| 11992480 | June 7, 2037 | Method of use | U-3773 | 217242 |
| 12005051 | June 7, 2037 | Method of use | U-3773 | 217242 |
| 9907788 | June 7, 2037 | Method of use | U-3773 | 217242 |
| 11819496 | June 7, 2037 | Method of use | U-3773 | 217242 |
| 12390453 | June 7, 2037 | Drug product | None | 217242 |
| 11129818 | August 25, 2037 | Method of use | U-3970 | 215985 |
| 11129818 | August 25, 2037 | Method of use | U-3712 | 215985 |
| 11129818 | August 25, 2037 | Method of use | U-3408 | 215985 |
| 11129818 | August 25, 2037 | Method of use | U-4578 | 215985 |
| 11129818 | August 25, 2037 | Method of use | U-4301 | 215985 |
| 11129818 | August 25, 2037 | Method of use | U-4203 | 217242 |
| 11129818 | August 25, 2037 | Method of use | U-3773 | 217242 |
| 12329751 | December 3, 2041 | Method of use | U-3773 | 217242 |
| 11707454 | December 3, 2041 | Method of use | U-3773 | 217242 |
| 12453721 | August 19, 2042 | Drug product | None | 217242 |
Zoryve exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | October 5, 2026 | 215985 |
| NP | New product | December 15, 2026 | 217242 |
| NS | New strength | July 9, 2027 | 215985 |
| I-969 | New indication | May 22, 2028 | 217242 |
| NS | New strength | October 4, 2028 | 215985 |
| NPP | New patient population | June 29, 2029 | 215985 |
Zoryve NDC codes
Questions
Is there a generic for Zoryve?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zoryve (roflumilast). The Orange Book shows its last listed patent expires August 19, 2042 and its last listed exclusivity ends June 29, 2029.
What is the generic name for Zoryve?
The active ingredient in Zoryve is roflumilast, per the FDA Orange Book.
When does the Zoryve patent expire?
The last patent listed for Zoryve in the Orange Book expires August 19, 2042. 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 Zoryve and Roflumilast
- What is Zoryve used for?FDA label uses
- Is Zoryve a controlled substance?Federal schedule
- What is Roflumilast used for?FDA label uses
- Is Roflumilast a controlled substance?Federal schedule
- Generic for DalirespFDA Orange Book
- Phosphodiesterase 4 Inhibitors listFDA drug class
- NDC 80610-105Zoryve NDC record
- NDC 80610-115Zoryve NDC record
- NDC 80610-130Zoryve NDC record