FDA Orange Book
Is there a generic for Doral?
Doral contains quazepam. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Doral (quazepam). The Orange Book shows its last listed patent expires June 3, 2028.
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Doral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 15MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 7.5MG | Discontinued | None | 0 | None |
NDA 018708, held by GALT PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Doral patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7608616 | June 3, 2028 | Method of use | U-1012 | 018708 |
Doral NDC codes
Questions
Is there a generic for Doral?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Doral (quazepam). The Orange Book shows its last listed patent expires June 3, 2028.
What is the generic name for Doral?
The active ingredient in Doral is quazepam, per the FDA Orange Book.
When does the Doral patent expire?
The last patent listed for Doral in the Orange Book expires June 3, 2028. 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.