FDA Orange Book
Is there a generic for Karbinal ER?
Karbinal ER contains carbinoxamine. 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 Karbinal ER (carbinoxamine). The Orange Book shows its last listed patent expires March 29, 2029.
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Karbinal ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| suspension, extended release, oral | 4MG/5ML | Marketed (Rx) | None | 0 | None |
NDA 022556, held by AYTU BIOSCIENCE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Karbinal ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9522191 | June 15, 2027 | Drug product | None | 022556 |
| 8062667 | March 29, 2029 | Drug product | None | 022556 |
Karbinal ER NDC codes
Questions
Is there a generic for Karbinal ER?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Karbinal ER (carbinoxamine). The Orange Book shows its last listed patent expires March 29, 2029.
What is the generic name for Karbinal ER?
The active ingredient in Karbinal ER is carbinoxamine, per the FDA Orange Book.
When does the Karbinal ER patent expire?
The last patent listed for Karbinal ER in the Orange Book expires March 29, 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.