FDA Orange Book
Generic for Silenor
Silenor contains doxepin. 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 Silenor is doxepin. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Silenor products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 3MG BASE | Marketed (Rx) | AB | 8 | AB |
| tablet, oral | EQ 6MG BASE | Marketed (Rx) | AB | 8 | AB |
NDA 022036, held by CURRAX PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic doxepin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 201951 | AB (A-rated, therapeutically equivalent) | July 26, 2013 | EQ 3MG BASE, EQ 6MG BASE |
| RK PHARMA INC | 202337 | AB (A-rated, therapeutically equivalent) | January 20, 2016 | EQ 3MG BASE, EQ 6MG BASE |
| STRIDES PHARMA INTERNATIONAL AG | 202510 | AB (A-rated, therapeutically equivalent) | July 24, 2020 | EQ 3MG BASE, EQ 6MG BASE |
| MSN LABORATORIES PRIVATE LTD | 214823 | AB (A-rated, therapeutically equivalent) | April 3, 2023 | EQ 3MG BASE, EQ 6MG BASE |
| ZYDUS LIFESCIENCES LTD | 202761 | AB (A-rated, therapeutically equivalent) | August 16, 2023 | EQ 3MG BASE, EQ 6MG BASE |
| AJANTA PHARMA LTD | 218564 | AB (A-rated, therapeutically equivalent) | July 1, 2024 | EQ 3MG BASE, EQ 6MG BASE |
| AUROBINDO PHARMA LTD | 216041 | AB (A-rated, therapeutically equivalent) | July 25, 2024 | EQ 3MG BASE, EQ 6MG BASE |
| TARO PHARMACEUTICAL INDUSTRIES LTD | 219058 | AB (A-rated, therapeutically equivalent) | August 6, 2025 | EQ 3MG BASE, EQ 6MG BASE |
Silenor patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9861607 | May 18, 2027 | Method of use | U-620 | 022036 |
| 12083090 | May 18, 2027 | Method of use | U-620 | 022036 |
| 9486437 | May 18, 2027 | Method of use | U-620 | 022036 |
| 10238620 | May 18, 2027 | Method of use | U-620 | 022036 |
| 10653662 | May 18, 2027 | Method of use | U-620 | 022036 |
| 9572814 | July 20, 2027 | Method of use | U-620 | 022036 |
| 10653660 | July 20, 2027 | Method of use | U-620 | 022036 |
| 11110074 | July 20, 2027 | Method of use | U-620 | 022036 |
| 7915307 | August 24, 2027 | Method of use | U-620 | 022036 |
| 11234954 | January 18, 2028 | Method of use | U-620 | 022036 |
| 10548871 | April 11, 2028 | Method of use | U-620 | 022036 |
| 11096920 | April 11, 2028 | Method of use | U-620 | 022036 |
| 9907780 | April 11, 2028 | Drug product | None | 022036 |
| 9107898 | May 1, 2028 | Method of use | U-620 | 022036 |
| 9532971 | June 1, 2029 | Drug product | None | 022036 |
| 8513299 | September 7, 2030 | Method of use | U-620 | 022036 |
Silenor NDC codes
Questions
Is there a generic for Silenor?
Yes. The generic name for Silenor is doxepin. 8 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 Silenor?
The active ingredient in Silenor is doxepin, per the FDA Orange Book.
When does the Silenor patent expire?
The last patent listed for Silenor in the Orange Book expires September 7, 2030. 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.