FDA Orange Book
Generic for Desyrel
Desyrel contains trazodone. 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 Desyrel is trazodone. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Desyrel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 100MG | Discontinued | None | 11 | AB |
| tablet, oral | 150MG | Discontinued | None | 10 | AB |
| tablet, oral | 300MG | Discontinued | None | 8 | AB |
| tablet, oral | 50MG | Discontinued | None | 11 | AB |
NDA 018207, held by PRAGMA PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trazodone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 071196 | AB (A-rated, therapeutically equivalent) | March 25, 1987 | 100MG, 150MG, 300MG |
| APOTEX INC | 071258 | AB (A-rated, therapeutically equivalent) | March 25, 1987 | 50MG |
| TEVA PHARMACEUTICALS USA INC | 071524 | AB (A-rated, therapeutically equivalent) | December 11, 1987 | 100MG |
| TEVA PHARMACEUTICALS USA INC | 071523 | AB (A-rated, therapeutically equivalent) | December 11, 1987 | 50MG |
| PLIVA INC | 071525 | AB (A-rated, therapeutically equivalent) | March 9, 1988 | 150MG |
| OXFORD PHARMACEUTICALS LLC | 072193 | AB (A-rated, therapeutically equivalent) | February 2, 1989 | 100MG |
| OXFORD PHARMACEUTICALS LLC | 072192 | AB (A-rated, therapeutically equivalent) | February 2, 1989 | 50MG |
| SUN PHARMACEUTICAL INDUSTRIES INC | 073137 | AB (A-rated, therapeutically equivalent) | March 24, 1993 | 100MG, 150MG, 50MG |
| TORRENT PHARMACEUTICALS LTD | 202180 | AB (A-rated, therapeutically equivalent) | November 27, 2013 | 100MG, 150MG, 300MG, 50MG |
| ACCORD HEALTHCARE INC | 206923 | AB (A-rated, therapeutically equivalent) | September 8, 2017 | 100MG, 150MG, 300MG, 50MG |
| ZYDUS PHARMACEUTICALS USA INC | 205253 | AB (A-rated, therapeutically equivalent) | October 10, 2017 | 100MG, 150MG, 300MG, 50MG |
| AUROBINDO PHARMA LTD | 204852 | AB (A-rated, therapeutically equivalent) | February 5, 2020 | 100MG, 150MG, 300MG, 50MG |
| CROSSMEDIKA SA | 211116 | AB (A-rated, therapeutically equivalent) | May 20, 2024 | 100MG, 150MG, 300MG, 50MG |
| GRANULES INDIA LTD | 218988 | AB (A-rated, therapeutically equivalent) | August 8, 2024 | 100MG, 150MG, 300MG, 50MG |
| GRAVITI PHARMACEUTICALS PRIVATE LTD | 217740 | AB (A-rated, therapeutically equivalent) | August 27, 2024 | 100MG, 150MG, 300MG, 50MG |
Desyrel patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8133893 | March 13, 2029 | Drug substance, Drug product | None | 018207 |
Questions
Is there a generic for Desyrel?
Yes. The generic name for Desyrel is trazodone. 12 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 Desyrel?
The active ingredient in Desyrel is trazodone, per the FDA Orange Book.
When does the Desyrel patent expire?
The last patent listed for Desyrel in the Orange Book expires March 13, 2029. 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.