FDA Orange Book

Is there a generic for Journavx?

Journavx contains suzetrigine. 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 Journavx (suzetrigine). The Orange Book shows its last listed patent expires December 4, 2040 and its last listed exclusivity ends January 30, 2030.

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Journavx products in the Orange Book

Journavx products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
tablet, oral50MGMarketed (Rx)None0None

NDA 219209, held by VERTEX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Journavx patents

Patents listed for Journavx
PatentExpiresCoversUse codeNDA
11834441December 4, 2040Drug substance, Drug productU-4125219209

Journavx exclusivity

Exclusivity listed for Journavx
CodeMeaningExpiresNDA
NCENew chemical entityJanuary 30, 2030219209

Journavx NDC codes

Questions

Is there a generic for Journavx?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Journavx (suzetrigine). The Orange Book shows its last listed patent expires December 4, 2040 and its last listed exclusivity ends January 30, 2030.

What is the generic name for Journavx?

The active ingredient in Journavx is suzetrigine, per the FDA Orange Book.

When does the Journavx patent expire?

The last patent listed for Journavx in the Orange Book expires December 4, 2040. 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.

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