FDA Orange Book
Is there a generic for Anzupgo?
Anzupgo contains delgocitinib. 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 Anzupgo (delgocitinib). The Orange Book shows its last listed patent expires September 19, 2031 and its last listed exclusivity ends July 23, 2030.
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Anzupgo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| cream, topical | 2% | Marketed (Rx) | None | 0 | None |
NDA 219155, held by LEO PHARMA AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Anzupgo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8609647 | September 19, 2031 | Drug substance, Drug product | U-4237 | 219155 |
Anzupgo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | July 23, 2030 | 219155 |
Anzupgo NDC codes
Questions
Is there a generic for Anzupgo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Anzupgo (delgocitinib). The Orange Book shows its last listed patent expires September 19, 2031 and its last listed exclusivity ends July 23, 2030.
What is the generic name for Anzupgo?
The active ingredient in Anzupgo is delgocitinib, per the FDA Orange Book.
When does the Anzupgo patent expire?
The last patent listed for Anzupgo in the Orange Book expires September 19, 2031. 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.