Generic competition · all medicines · read 12 November 2026
Is there a generic of Oxycodone Hydrochloride, and who makes it?
Oxycodone Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 18 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 1.8 and 3.4 years after the first brand approval. This is the Orange Book's listing, not a forecast.
Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.
- Oxycodone Hydrochloride appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 18 generic makers listed as marketed across them.
- 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
- Where both are dated, the first generic approval came between 1.8 and 3.4 years after the first brand approval.
- Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.
Tablet, Oral
Four or more generic makers listed
Brand listed as marketed: Roxicodone and Roxybond. 10 generic makers with 49 generic products listed as marketed; the first generic approval is dated 6 February 2004.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Specgx Llc | 30 June 2004 | 5 |
| Strides Pharma International Ag | 31 January 2007 | 5 |
| Epic Pharma Llc | 24 August 2009 | 8 |
| Avanthi Inc | 31 August 2009 | 5 |
| Rhodes Pharmaceuticals Lp | 9 March 2011 | 5 |
| Alvogen Inc | 30 December 2011 | 3 |
| Aurolife Pharma Llc | 19 November 2012 | 3 |
| Amneal Pharmaceuticals | 3 June 2014 | 5 |
| Nuvo Pharmaceutical Inc | 12 April 2016 | 5 |
| Ascent Pharmaceuticals Inc | 7 August 2017 | 5 |
Patents and exclusivities still listed
- 12 August 2028Patent 7955619 drug product
- 12 August 2028Patent 10314788 drug product
Solution, Oral
Four or more generic makers listed
Brand listed as marketed: Oxycodone Hydrochloride. 9 generic makers with 15 generic products listed as marketed; the first generic approval is dated 30 July 2012.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Hikma Pharmaceuticals Usa Inc | 15 July 2013 | 1 |
| Ani Pharmaceuticals Inc | 1 June 2015 | 1 |
| Adaptis Pharma Private Ltd | 23 November 2016 | 2 |
| Abhai Llc | 21 July 2017 | 2 |
| Ascent Pharmaceuticals Inc | 9 November 2017 | 2 |
| Specgx Llc | 30 April 2018 | 2 |
| Pharmaceutical Associates Inc | 1 February 2019 | 1 |
| Alkem Laboratories Ltd | 4 February 2019 | 2 |
| Quagen Pharmaceuticals Llc | 2 June 2021 | 2 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
Tablet, Extended Release, Oral
Brand listed, no generic listed as marketed
Brand listed as marketed: Oxycontin. No generic is listed as marketed.
Patents and exclusivities still listed
- 24 August 2027Patent 8808741
- 24 August 2027Patent 9492393
- 24 August 2027Patent 9492391
- 24 August 2027Patent 11304909
- 24 August 2027Patent 9775808 drug product
- 24 August 2027Patent 12246094 drug product
- 24 August 2027Patent 9492389 drug product
- 24 August 2027Patent 11964056 drug product
7 more patents are listed.
Capsule, Oral
One to three generic makers listed
Brand listed as marketed: Oxycodone Hydrochloride. 3 generic makers with 3 generic products listed as marketed; the first generic approval is dated 26 July 2012.
| Generic maker (applicant) | First approval | Products |
|---|---|---|
| Avanthi Inc | 17 August 2015 | 1 |
| Novel Laboratories Inc | 24 August 2015 | 1 |
| Ani Pharmaceuticals Inc | 31 March 2016 | 1 |
Patents and exclusivities still listed
No unexpired patent or exclusivity is listed against the marketed brand products in this group.
US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.
Where can you go from this result?
Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.