Orange Book product · Brand (NDA)
OXYCONTIN
OXYCODONE HYDROCHLORIDE
At a glance
Apr 05, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 05, 2010
16 yr 5 mo ago
Today
Patent 11304908 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 11304909 expires
Listed method-of-use patent (U-1556) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 11964056 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 12246094 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 12280152 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 8808741 expires
Listed method-of-use patent (U-1556) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 8894988 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9492389 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9492391 expires
Listed method-of-use patent (U-1556) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9492392 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9492393 expires
Listed method-of-use patent (U-1556) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9763933 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9770416 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9775808 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 8894987 expires
Listed drug product patent expiration.
Mar 29, 2030
in 3 yr 10 mo
Pharmaceutical detail
Active ingredient
OXYCODONE HYDROCHLORIDE
Strength
10MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022272
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2013OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 200535 · GENUS LIFESCIENCES
- 2012OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 201194 · VISTAPHARM LLC
- 2011OXAYDOBrand (NDA)
NDA 202080 · ZYLA
- 2010OXYCODONE HYDROCHLORIDEBrand (NDA)
NDA 200534 · GENUS LIFESCIENCES
- 2009ROXICODONEBrand (NDA)
NDA 021011 · SPECGX LLC
- 1998ROXICODONEBrand (NDA)
NDA 020932 · ROXANE
- 2025OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 207418 · ASCENT PHARMS INC
- 2021OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 213761 · QUAGEN
- 2020OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 205853 · RHODES PHARMS
- 2020OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 212429 · AUROLIFE PHARMA LLC
- 2019OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 211748 · ALKEM LABS LTD
- 2019OXYCODONE HYDROCHLORIDEGeneric (ANDA)
ANDA 211749 · ALKEM LABS LTD
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11304908 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 11304909 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 11964056 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 12246094 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 12280152 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 8808741 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 8894988 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492389 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492391 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492392 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492393 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9763933 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9770416 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9775808 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 8894987 | Mar 29, 2030 | in 3 yr 10 mo | Product |
