FDA Orange Book
Generic for Pristiq
Pristiq contains desvenlafaxine. 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 Pristiq is desvenlafaxine. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Pristiq products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 100MG BASE | Marketed (Rx) | AB | 10 | AB |
| tablet, extended release, oral | EQ 25MG BASE | Marketed (Rx) | AB | 8 | AB |
| tablet, extended release, oral | EQ 50MG BASE | Marketed (Rx) | AB | 10 | AB |
NDA 021992, held by PF PRISM CV. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic desvenlafaxine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALEMBIC PHARMACEUTICALS LTD | 204003 | AB (A-rated, therapeutically equivalent) | June 29, 2015 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| LUPIN LTD | 204172 | AB (A-rated, therapeutically equivalent) | June 29, 2015 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| RUBICON RESEARCH LTD | 204028 | AB (A-rated, therapeutically equivalent) | June 29, 2015 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| HIKMA PHARMACEUTICALS USA INC | 204083 | AB (A-rated, therapeutically equivalent) | February 16, 2016 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| ACTAVIS LABORATORIES FL INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 204065 | AB (A-rated, therapeutically equivalent) | July 29, 2016 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| ZYDUS PHARMACEUTICALS USA INC | 204020 | AB (A-rated, therapeutically equivalent) | October 11, 2017 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 210014 | AB (A-rated, therapeutically equivalent) | October 1, 2018 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
| PLATINUM PHARMACEUTICALS | 204805 | AB (A-rated, therapeutically equivalent) | May 7, 2019 | EQ 100MG BASE, EQ 50MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 211427 | AB (A-rated, therapeutically equivalent) | January 15, 2025 | EQ 100MG BASE, EQ 50MG BASE |
| YICHANG HUMANWELL PHARMACEUTICAL CO LTD | 220460 | AB (A-rated, therapeutically equivalent) | March 10, 2026 | EQ 100MG BASE, EQ 25MG BASE, EQ 50MG BASE |
Pristiq patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8269040 | July 5, 2027 | Drug substance | None | 021992 |
Pristiq NDC codes
Questions
Is there a generic for Pristiq?
Yes. The generic name for Pristiq is desvenlafaxine. 9 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 Pristiq?
The active ingredient in Pristiq is desvenlafaxine, per the FDA Orange Book.
When does the Pristiq patent expire?
The last patent listed for Pristiq in the Orange Book expires July 5, 2027. 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.