FDA Orange Book
Generic for Vivactil
Vivactil contains protriptyline. 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
Yes. The generic name for Vivactil is protriptyline. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Vivactil products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Discontinued | None | 2 | AB |
| tablet, oral | 5MG | Discontinued | None | 2 | AB |
NDA 016012, held by TEVA WOMENS HEALTH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic protriptyline
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SIGMAPHARM LABORATORIES LLC | 090462 | AB (A-rated, therapeutically equivalent) | May 3, 2010 | 10MG, 5MG |
| EPIC PHARMA LLC | 202220 | AB (A-rated, therapeutically equivalent) | November 19, 2012 | 10MG, 5MG |
Questions
Is there a generic for Vivactil?
Yes. The generic name for Vivactil is protriptyline. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Vivactil?
The active ingredient in Vivactil is protriptyline, per the FDA Orange Book.
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.