FDA Orange Book
Generic for Vantrela ER
Vantrela 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 Vantrela ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Vantrela ER products the Orange Book lists.
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Vantrela ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 15MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 30MG | Discontinued | None | 1 | AB |
| tablet, extended release, oral | 45MG | Discontinued | None | 0 | None |
| tablet, extended release, oral | 60MG | Discontinued | None | 1 | AB |
| tablet, extended release, oral | 90MG | Discontinued | None | 0 | None |
NDA 207975, held by TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC. 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 | 208269 | AB (A-rated, therapeutically equivalent) | March 1, 2021 | 30MG, 60MG |
Vantrela ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9216176 | September 13, 2027 | Drug product | None | 207975 |
| 9572803 | September 13, 2027 | Drug product | None | 207975 |
| 8445018 | July 31, 2029 | Drug product | None | 207975 |
Questions
Is there a generic for Vantrela ER?
Yes. The generic name for Vantrela ER is hydrocodone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 5 Vantrela ER products the Orange Book lists.
What is the generic name for Vantrela ER?
The active ingredient in Vantrela ER is hydrocodone, per the FDA Orange Book.
When does the Vantrela ER patent expire?
The last patent listed for Vantrela ER in the Orange Book expires July 31, 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.