FDA Orange Book
Is there a generic for Sympazan?
Sympazan contains clobazam. 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 Sympazan (clobazam). The Orange Book shows its last listed patent expires January 31, 2040.
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Sympazan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| film, oral | 10MG | Marketed (Rx) | None | 0 | None |
| film, oral | 20MG | Marketed (Rx) | None | 0 | None |
| film, oral | 5MG | Marketed (Rx) | None | 0 | None |
NDA 210833, held by COSETTE PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Sympazan patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12403090 | September 5, 2039 | Drug product | U-724 | 210833 |
| 12290597 | September 5, 2039 | Drug product | U-724 | 210833 |
| 11541002 | January 31, 2040 | Drug product | U-724 | 210833 |
Sympazan NDC codes
Questions
Is there a generic for Sympazan?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Sympazan (clobazam). The Orange Book shows its last listed patent expires January 31, 2040.
What is the generic name for Sympazan?
The active ingredient in Sympazan is clobazam, per the FDA Orange Book.
When does the Sympazan patent expire?
The last patent listed for Sympazan in the Orange Book expires January 31, 2040. 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.
More on Sympazan and Clobazam
- What is Sympazan used for?FDA label uses
- Is Sympazan a controlled substance?Schedule IV
- What is Clobazam used for?FDA label uses
- Is Clobazam a controlled substance?Schedule IV
- Generic for OnfiFDA Orange Book
- Benzodiazepines listFDA drug class
- NDC 10094-205Sympazan NDC record
- NDC 10094-210Sympazan NDC record
- NDC 10094-220Sympazan NDC record
- Schedule IV drugs listDEA schedule