Orange Book product · Brand (NDA)
ZOHYDRO ER
HYDROCODONE BITARTRATE
At a glance
Oct 25, 2013
Approved
Brand (NDA)
Application
Not listed
TE code
16
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 25, 2013
12 yr 10 mo ago
Today
Patent 10028946 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 10322120 expires
Listed drug product patent expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 10456393 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 10722511 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9265760 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9326982 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9333201 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9339499 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9421200 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9433619 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 9610286 expires
Listed method-of-use patent (U-1810) expiration.
Jul 25, 2033
in 7 yr 2 mo
Patent 10092559 expires
Listed method-of-use patent (U-55) expiration.
Sep 12, 2034
in 8 yr 4 mo
Patent 9132096 expires
Listed drug product patent expiration.
Sep 12, 2034
in 8 yr 4 mo
Patent 9452163 expires
Listed method-of-use patent (U-55) expiration.
Sep 12, 2034
in 8 yr 4 mo
Patent 9486451 expires
Listed method-of-use patent (U-55) expiration.
Sep 12, 2034
in 8 yr 4 mo
Patent 9713611 expires
Listed drug product patent expiration.
Sep 12, 2034
in 8 yr 4 mo
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE
Strength
40MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 202880
Product number
005
Marketing status
DISCN
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.
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10028946 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10322120 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 10456393 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10722511 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9265760 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9326982 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9333201 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9339499 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9421200 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9433619 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9610286 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10092559 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 9132096 | Sep 12, 2034 | in 8 yr 4 mo | Product |
| 9452163 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 9486451 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 9713611 | Sep 12, 2034 | in 8 yr 4 mo | ProductU-55 |
