FDA Orange Book · active-ingredient family
Oxycodone hydrochloride
Oxycodone hydrochloride is approved as 8 brand and 44 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OXYCODONE HYDROCHLORIDE · NDA 200535
8
Brand (NDA)
44
Generics (ANDA)
17
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDERLD×2 | GENUS LIFESCIENCES | NDA 200535 | AA | Aug 22, 2013 | |
| OXYCODONE HYDROCHLORIDERLD | VISTAPHARM LLC | NDA 201194 | — | Jan 12, 2012 | |
| OXAYDORLD×2 | ZYLA | NDA 202080 | — | Jun 17, 2011 | |
| OXYCODONE HYDROCHLORIDERLD | GENUS LIFESCIENCES | NDA 200534 | AB | Oct 20, 2010 | |
| OXYCONTINRLD×7 | KNOA PHARMA | NDA 022272 | — | Apr 05, 2010 | |
| ROXICODONERLD×3 | SPECGX LLC | NDA 021011 | AB | May 15, 2009 | |
| ROXYBOND×4 | PROTEGA PHARMS | NDA 209777 | — | Apr 20, 2017 | |
| ROXICODONE×2 | ROXANE | NDA 020932 | — | Oct 26, 1998 |
Generic (ANDA) products (44)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE×5 | ASCENT PHARMS INC | ANDA 207418 | AB | Nov 14, 2025 | |
| OXYCODONE HYDROCHLORIDE×2 | QUAGEN | ANDA 213761 | AA | Jun 02, 2021 | |
| OXYCODONE HYDROCHLORIDE | RHODES PHARMS | ANDA 205853 | — | Apr 29, 2020 | |
| OXYCODONE HYDROCHLORIDE×2 | AUROLIFE PHARMA LLC | ANDA 212429 | — | Jan 27, 2020 | |
| OXYCODONE HYDROCHLORIDE | ALKEM LABS LTD | ANDA 211748 | AA | Feb 07, 2019 | |
| OXYCODONE HYDROCHLORIDE | ALKEM LABS LTD | ANDA 211749 | AA | Feb 04, 2019 | |
| OXYCODONE HYDROCHLORIDE | PHARM ASSOC | ANDA 206914 | AA | Feb 01, 2019 | |
| OXYCODONE HYDROCHLORIDE×2 | SPECGX LLC | ANDA 210758 | AA | Apr 30, 2018 | |
| OXYCODONE HYDROCHLORIDE×2 | ASCENT PHARMS INC | ANDA 209021 | AA | Nov 09, 2017 | |
| OXYCODONE HYDROCHLORIDE | HIBROW HLTHCARE | ANDA 209897 | AA | Sep 06, 2017 | |
| OXYCODONE HYDROCHLORIDE | ANI PHARMS | ANDA 203447 | — | Aug 30, 2017 | |
| OXYCODONE HYDROCHLORIDE | PHARM ASSOC | ANDA 206822 | — | Aug 15, 2017 | |
| OXYCODONE HYDROCHLORIDE | HIKMA | ANDA 208817 | — | Aug 10, 2017 | |
| OXYCODONE HYDROCHLORIDE | HIKMA | ANDA 208795 | — | Aug 07, 2017 | |
| OXYCODONE HYDROCHLORIDE×2 | ABHAI LLC | ANDA 208593 | AA | Jul 21, 2017 | |
| OXYCODONE HYDROCHLORIDE×5 | NOVEL LABS INC | ANDA 204021 | — | Jun 12, 2017 | |
| OXYCODONE HYDROCHLORIDE | HIBROW HLTHCARE | ANDA 207511 | AA | Nov 23, 2016 | |
| OXYCODONE HYDROCHLORIDE×5 | NUVO PHARM | ANDA 207119 | AB | Apr 12, 2016 | |
| OXYCODONE HYDROCHLORIDE | ANI PHARMS | ANDA 205177 | AB | Mar 31, 2016 | |
| OXYCODONE HYDROCHLORIDE×5 | EPIC PHARMA LLC | ANDA 202662 | AB | Sep 22, 2015 | |
| OXYCODONE HYDROCHLORIDE | NOVEL LABS INC | ANDA 204752 | AB | Aug 24, 2015 | |
| OXYCODONE HYDROCHLORIDE | AVANTHI INC | ANDA 202773 | AB | Aug 17, 2015 | |
| OXYCODONE HYDROCHLORIDE | PHARMOBEDIENT | ANDA 206456 | — | Jun 16, 2015 | |
| OXYCODONE HYDROCHLORIDE | ANI PHARMS | ANDA 204979 | AA | Jun 01, 2015 | |
| OXYCODONE HYDROCHLORIDE | NOVEL LABS INC | ANDA 204603 | — | Apr 29, 2015 | |
| OXYCODONE HYDROCHLORIDE×3 | ACTAVIS ELIZABETH | ANDA 076636 | — | Apr 07, 2015 | |
| OXYCODONE HYDROCHLORIDE | CHARTWELL MOLECULAR | ANDA 204085 | — | Sep 09, 2014 | |
| OXYCODONE HYDROCHLORIDE | LANNETT CO INC | ANDA 203823 | — | Aug 01, 2014 | |
| OXYCODONE HYDROCHLORIDE | DR REDDYS LABS SA | ANDA 204092 | — | Jun 05, 2014 | |
| OXYCODONE HYDROCHLORIDE×5 | AMNEAL PHARMS | ANDA 203638 | AB | Jun 03, 2014 | |
| OXYCODONE HYDROCHLORIDE | HIKMA | ANDA 204037 | AA | Jul 15, 2013 | |
| OXYCODONE HYDROCHLORIDE | HIKMA | ANDA 203208 | — | Jul 12, 2013 | |
| OXYCODONE HYDROCHLORIDE×3 | AUROLIFE PHARMA LLC | ANDA 202160 | AB | Nov 19, 2012 | |
| OXYCODONE HYDROCHLORIDE | VISTAPHARM LLC | ANDA 202537 | — | Jul 30, 2012 | |
| OXYCODONE HYDROCHLORIDE | DR REDDYS LABS SA | ANDA 203107 | — | Jul 26, 2012 | |
| OXYCODONE HYDROCHLORIDE×3 | ALVOGEN | ANDA 202116 | AB | Dec 30, 2011 | |
| OXYCODONE HYDROCHLORIDE×5 | RHODES PHARMS | ANDA 091490 | AB | Mar 09, 2011 | |
| OXYCODONE HYDROCHLORIDE×5 | DR REDDYS LABS SA | ANDA 091313 | — | Feb 18, 2011 | |
| OXYCODONE HYDROCHLORIDE×5 | AVANTHI INC | ANDA 091393 | AB | Aug 31, 2009 | |
| OXYCODONE HYDROCHLORIDE×3 | EPIC PHARMA LLC | ANDA 090895 | AB | Aug 24, 2009 | |
| OXYCODONE HYDROCHLORIDE×5 | SUN PHARM INDS INC | ANDA 090659 | — | Apr 10, 2009 | |
| OXYCODONE HYDROCHLORIDE×5 | STRIDES PHARMA INTL | ANDA 077712 | AB | Mar 02, 2009 | |
| OXYCODONE HYDROCHLORIDE×5 | SPECGX LLC | ANDA 076758 | AB | Mar 19, 2007 | |
| OXYCODONE HYDROCHLORIDE×5 | NESHER PHARMS | ANDA 077290 | — | Dec 08, 2005 |
Listed patents (17)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8808741 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492393 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492391 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 11304909 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9775808 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 12246094 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492389 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 11964056 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9763933 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 11304908 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492392 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 12280152 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9770416 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 8894988 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 7955619 | Aug 12, 2028 | in 2 yr 2 mo | Product |
| 10314788 | Aug 12, 2028 | in 2 yr 2 mo | Product |
| 8894987 | Mar 29, 2030 | in 3 yr 10 mo | Product |
Oxycodone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
