Orange Book product · Brand (NDA)
HYSINGLA ER
HYDROCODONE BITARTRATE
At a glance
Nov 20, 2014
Approved
Brand (NDA)
Application
AB
TE code
19
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 20, 2014
11 yr 9 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 9084816 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9095614 expires
Listed method-of-use patent (U-1556) expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9095615 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9486412 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 9486413 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 9492390 expires
Listed method-of-use patent (U-1556) 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 9545380 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 9775809 expires
Listed drug product patent expiration.
Aug 24, 2027
in 1 yr 2 mo
Patent 8808740 expires
Listed drug product patent expiration.
Dec 21, 2031
in 5 yr 7 mo
Patent 9572779 expires
Listed drug product patent expiration.
Dec 21, 2031
in 5 yr 7 mo
Patent 9750703 expires
Listed drug product patent expiration.
Dec 21, 2031
in 5 yr 7 mo
Patent 9861584 expires
Listed drug product patent expiration.
Dec 21, 2031
in 5 yr 7 mo
Patent 9872837 expires
Listed drug product patent expiration.
Dec 21, 2031
in 5 yr 7 mo
Pharmaceutical detail
Active ingredient
HYDROCODONE BITARTRATE
Strength
20MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 206627
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (19)
| 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 |
| 9084816 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9095614 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9095615 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9486412 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9486413 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492389 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9492390 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492391 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9545380 | 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 |
| 9775809 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 8808740 | Dec 21, 2031 | in 5 yr 7 mo | ProductU-1556 |
| 9572779 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9750703 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9861584 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9872837 | Dec 21, 2031 | in 5 yr 7 mo | Product |
