FDA Orange Book
Is there a generic for Acthar Gel?
Acthar Gel contains corticotropin. 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 Acthar Gel (corticotropin). The Orange Book shows its last listed patent expires July 18, 2041.
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Acthar Gel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 40 UNITS/ML | Discontinued | None | 0 | None |
| injectable, injection | 80 UNITS/ML | Marketed (Rx) | None | 0 | None |
NDA 008372, held by MALLINCKRODT PHARMACEUTICALS IRELAND LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Acthar Gel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11752199 | July 18, 2041 | Method of use | U-3686 | 008372 |
| 11752199 | July 18, 2041 | Method of use | U-3687 | 008372 |
| 11752199 | July 18, 2041 | Method of use | U-3688 | 008372 |
Acthar Gel NDC codes
Questions
Is there a generic for Acthar Gel?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Acthar Gel (corticotropin). The Orange Book shows its last listed patent expires July 18, 2041.
What is the generic name for Acthar Gel?
The active ingredient in Acthar Gel is corticotropin, per the FDA Orange Book.
When does the Acthar Gel patent expire?
The last patent listed for Acthar Gel in the Orange Book expires July 18, 2041. 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.