FDA Orange Book
Generic for Opana ER
Opana ER contains oxymorphone. 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 Opana ER is oxymorphone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Opana ER products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 10MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 15MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 15MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 20MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 20MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 30MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 30MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 40MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 40MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 5MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 5MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 7.5MG | Discontinued | None | 1 | None |
| tablet, extended release, oral | 7.5MG | Discontinued | None | 1 | None |
NDA 021610, 201655, held by ENDO OPERATIONS LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxymorphone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| IMPAX LABORATORIES INC | 079087 | None (No TE code listed) | June 14, 2010 | 10MG, 10MG, 15MG, 15MG, 20MG, 20MG, 30MG, 30MG, 40MG, 40MG, 5MG, 5MG, 7.5MG, 7.5MG |
Opana ER patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8808737 | June 21, 2027 | Method of use | U-3085 | 021610 |
| 8808737 | June 21, 2027 | Method of use | U-1598 | 201655 |
| 7851482 | July 10, 2029 | Drug substance | None | 201655 |
| 8871779 | November 22, 2029 | Drug substance | None | 021610 |
Questions
Is there a generic for Opana ER?
Yes. The generic name for Opana ER is oxymorphone. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Opana ER?
The active ingredient in Opana ER is oxymorphone, per the FDA Orange Book.
When does the Opana ER patent expire?
The last patent listed for Opana ER in the Orange Book expires November 22, 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.