FDA Orange Book
Is there a generic for Tonmya?
Tonmya contains cyclobenzaprine. 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 Tonmya (cyclobenzaprine). The Orange Book shows its last listed patent expires March 14, 2034 and its last listed exclusivity ends August 15, 2028.
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Tonmya products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, sublingual | 2.8MG | Marketed (Rx) | None | 0 | None |
NDA 219428, held by TONIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Tonmya patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10117936 | March 14, 2034 | Drug product | None | 219428 |
| 10864175 | March 14, 2034 | Drug product | None | 219428 |
| 9636408 | March 14, 2034 | Drug product | None | 219428 |
| 9956188 | March 14, 2034 | Drug product | None | 219428 |
Tonmya exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | August 15, 2028 | 219428 |
Tonmya NDC codes
Questions
Is there a generic for Tonmya?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Tonmya (cyclobenzaprine). The Orange Book shows its last listed patent expires March 14, 2034 and its last listed exclusivity ends August 15, 2028.
What is the generic name for Tonmya?
The active ingredient in Tonmya is cyclobenzaprine, per the FDA Orange Book.
When does the Tonmya patent expire?
The last patent listed for Tonmya in the Orange Book expires March 14, 2034. 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.