FDA Orange Book
Generic for Zohydro ER
Zohydro ER contains hydrocodone. 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 Zohydro ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Zohydro ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 10MG | Discontinued | None | 1 | None |
| capsule, extended release, oral | 15MG | Discontinued | None | 1 | None |
| capsule, extended release, oral | 20MG | Discontinued | None | 1 | None |
| capsule, extended release, oral | 30MG | Discontinued | None | 1 | None |
| capsule, extended release, oral | 40MG | Discontinued | None | 1 | None |
| capsule, extended release, oral | 50MG | Discontinued | None | 1 | None |
NDA 202880, held by RECRO GAINESVILLE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic hydrocodone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ALVOGEN INC | 206986 | None (No TE code listed) | January 21, 2020 | 10MG, 15MG, 20MG, 30MG, 40MG, 50MG |
Zohydro ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9326982 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9339499 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 10456393 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 10028946 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9265760 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9433619 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 10722511 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9610286 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9421200 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 9333201 | July 25, 2033 | Method of use | U-1810 | 202880 |
| 10322120 | July 25, 2033 | Drug product | None | 202880 |
| 9713611 | September 12, 2034 | Drug product | U-55 | 202880 |
| 9486451 | September 12, 2034 | Method of use | U-55 | 202880 |
| 9452163 | September 12, 2034 | Method of use | U-55 | 202880 |
| 10092559 | September 12, 2034 | Method of use | U-55 | 202880 |
| 9132096 | September 12, 2034 | Drug product | None | 202880 |
Questions
Is there a generic for Zohydro ER?
Yes. The generic name for Zohydro ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Zohydro ER?
The active ingredient in Zohydro ER is hydrocodone, per the FDA Orange Book.
When does the Zohydro ER patent expire?
The last patent listed for Zohydro ER in the Orange Book expires September 12, 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.