FDA Orange Book
Is there a generic for OxyContin?
OxyContin 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for OxyContin (oxycodone). The Orange Book shows its last listed patent expires March 29, 2030.
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OxyContin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 15MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 20MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 30MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 40MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 60MG | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | 80MG | Marketed (Rx) | None | 0 | None |
NDA 022272, held by KNOA PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
OxyContin patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8808741 | August 24, 2027 | Method of use | U-1556 | 022272 |
| 9492393 | August 24, 2027 | Method of use | U-1556 | 022272 |
| 9492391 | August 24, 2027 | Method of use | U-1556 | 022272 |
| 11304909 | August 24, 2027 | Method of use | U-1556 | 022272 |
| 9775808 | August 24, 2027 | Drug product | None | 022272 |
| 12246094 | August 24, 2027 | Drug product | None | 022272 |
| 9492389 | August 24, 2027 | Drug product | None | 022272 |
| 11964056 | August 24, 2027 | Drug product | None | 022272 |
| 9763933 | August 24, 2027 | Drug product | None | 022272 |
| 11304908 | August 24, 2027 | Drug product | None | 022272 |
| 9492392 | August 24, 2027 | Drug product | None | 022272 |
| 12280152 | August 24, 2027 | Drug product | None | 022272 |
| 9770416 | August 24, 2027 | Drug product | None | 022272 |
| 8894988 | August 24, 2027 | Drug product | None | 022272 |
| 8894987 | March 29, 2030 | Drug product | None | 022272 |
OxyContin NDC codes
Questions
Is there a generic for OxyContin?
No. The Orange Book lists no active FDA-approved generic (ANDA) for OxyContin (oxycodone). The Orange Book shows its last listed patent expires March 29, 2030.
What is the generic name for OxyContin?
The active ingredient in OxyContin is oxycodone, per the FDA Orange Book.
When does the OxyContin patent expire?
The last patent listed for OxyContin in the Orange Book expires March 29, 2030. 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 OxyContin and Oxycodone
- What is OxyContin used for?FDA label uses
- Is OxyContin a controlled substance?Schedule II
- What is Oxycodone used for?FDA label uses
- Is Oxycodone a controlled substance?Schedule II
- Generic for Xtampza ERFDA Orange Book
- Generic for RoxicodoneFDA Orange Book
- Generic for OxaydoFDA Orange Book
- Generic for RoxyBondFDA Orange Book
- Opioid Agonists listFDA drug class
- OxyContin Medicare Part D coverageBy plan and state
- NDC 59011-410OxyContin NDC record
- NDC 59011-415OxyContin NDC record
- NDC 59011-420OxyContin NDC record
- Schedule II drugs listDEA schedule