FDA Orange Book
Generic for RoxyBond
RoxyBond contains oxycodone. 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 RoxyBond is oxycodone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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RoxyBond products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 8 | AB |
| tablet, oral | 15MG | Marketed (Rx) | None | 11 | AB |
| tablet, oral | 30MG | Marketed (Rx) | None | 11 | AB |
| tablet, oral | 5MG | Marketed (Rx) | None | 11 | AB |
NDA 209777, held by PROTEGA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic oxycodone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 090895 | AB (A-rated, therapeutically equivalent) | August 24, 2009 | 15MG, 30MG, 5MG |
| AVANTHI INC | 091393 | AB (A-rated, therapeutically equivalent) | August 31, 2009 | 10MG, 15MG, 30MG, 5MG |
| RHODES PHARMACEUTICALS LP | 091490 | AB (A-rated, therapeutically equivalent) | March 9, 2011 | 10MG, 15MG, 30MG, 5MG |
| ALVOGEN INC | 202116 | AB (A-rated, therapeutically equivalent) | December 30, 2011 | 15MG, 30MG, 5MG |
| AUROLIFE PHARMA LLC | 202160 | AB (A-rated, therapeutically equivalent) | November 19, 2012 | 15MG, 30MG, 5MG |
| AMNEAL PHARMACEUTICALS | 203638 | AB (A-rated, therapeutically equivalent) | June 3, 2014 | 10MG, 15MG, 30MG, 5MG |
| STRIDES PHARMA INTERNATIONAL AG | 077712 | AB (A-rated, therapeutically equivalent) | April 13, 2015 | 10MG, 15MG, 30MG, 5MG |
| EPIC PHARMA LLC | 202662 | AB (A-rated, therapeutically equivalent) | September 22, 2015 | 10MG, 15MG, 30MG, 5MG |
| NUVO PHARMACEUTICAL INC | 207119 | AB (A-rated, therapeutically equivalent) | April 12, 2016 | 10MG, 15MG, 30MG, 5MG |
| SPECGX LLC | 076758 | AB (A-rated, therapeutically equivalent) | October 12, 2021 | 10MG, 15MG, 30MG, 5MG |
| ASCENT PHARMACEUTICALS INC | 207418 | AB (A-rated, therapeutically equivalent) | November 14, 2025 | 10MG, 15MG, 30MG, 5MG |
RoxyBond patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7955619 | August 12, 2028 | Drug product | None | 209777 |
| 10314788 | August 12, 2028 | Drug product | None | 209777 |
RoxyBond NDC codes
Questions
Is there a generic for RoxyBond?
Yes. The generic name for RoxyBond is oxycodone. 10 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for RoxyBond?
The active ingredient in RoxyBond is oxycodone, per the FDA Orange Book.
When does the RoxyBond patent expire?
The last patent listed for RoxyBond in the Orange Book expires August 12, 2028. 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.
More on RoxyBond and Oxycodone
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- Is RoxyBond a controlled substance?Schedule II
- What is Oxycodone used for?FDA label uses
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- Schedule II drugs listDEA schedule