FDA Orange Book
Generic for Intermezzo
Intermezzo contains zolpidem. 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 Intermezzo is zolpidem. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Intermezzo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, sublingual | 1.75MG | Discontinued | None | 3 | AB |
| tablet, sublingual | 3.5MG | Discontinued | None | 3 | AB |
NDA 022328, held by PURDUE PHARMA PRODUCTS LP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic zolpidem
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NOVEL LABORATORIES INC | 204299 | AB (A-rated, therapeutically equivalent) | June 3, 2015 | 1.75MG, 3.5MG |
| DR REDDYS LABORATORIES INC | 204503 | AB (A-rated, therapeutically equivalent) | November 18, 2016 | 1.75MG, 3.5MG |
| PH HEALTH LTD | 204229 | AB (A-rated, therapeutically equivalent) | September 11, 2017 | 1.75MG, 3.5MG |
Intermezzo patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7658945 | April 15, 2027 | Drug product | U-1194 | 022328 |
| 8242131 | August 20, 2029 | Method of use | U-1266 | 022328 |
Questions
Is there a generic for Intermezzo?
Yes. The generic name for Intermezzo is zolpidem. 3 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 Intermezzo?
The active ingredient in Intermezzo is zolpidem, per the FDA Orange Book.
When does the Intermezzo patent expire?
The last patent listed for Intermezzo in the Orange Book expires August 20, 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.