FDA Orange Book
Is there a generic for Zypitamag?
Zypitamag contains pitavastatin. 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 Zypitamag (pitavastatin). The Orange Book shows its last listed patent expires January 19, 2031.
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Zypitamag products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 1MG BASE | Discontinued | None | 0 | None |
| tablet, oral | EQ 2MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | EQ 4MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208379, held by MEDICURE INTERNATIONAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zypitamag patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8829186 | January 19, 2031 | Drug substance, Drug product | None | 208379 |
Zypitamag NDC codes
Questions
Is there a generic for Zypitamag?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zypitamag (pitavastatin). The Orange Book shows its last listed patent expires January 19, 2031.
What is the generic name for Zypitamag?
The active ingredient in Zypitamag is pitavastatin, per the FDA Orange Book.
When does the Zypitamag patent expire?
The last patent listed for Zypitamag in the Orange Book expires January 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.