FDA Orange Book
Is there a generic for Juxtapid?
Juxtapid contains lomitapide. 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 Juxtapid (lomitapide). The Orange Book shows its last listed patent expires July 29, 2041 and its last listed exclusivity ends February 25, 2029.
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Juxtapid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 20MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 2MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 30MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 40MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 60MG BASE | Discontinued | None | 0 | None |
NDA 203858, held by CHIESI FARMACEUTICI SPA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Juxtapid patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7932268 | August 19, 2027 | Method of use | U-1316 | 203858 |
| 12472172 | July 29, 2041 | Method of use | U-4438 | 203858 |
Juxtapid exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NS | New strength | February 25, 2029 | 203858 |
| NPP | New patient population | February 25, 2029 | 203858 |
Juxtapid NDC codes
Questions
Is there a generic for Juxtapid?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Juxtapid (lomitapide). The Orange Book shows its last listed patent expires July 29, 2041 and its last listed exclusivity ends February 25, 2029.
What is the generic name for Juxtapid?
The active ingredient in Juxtapid is lomitapide, per the FDA Orange Book.
When does the Juxtapid patent expire?
The last patent listed for Juxtapid in the Orange Book expires July 29, 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.