FDA Orange Book · active-ingredient family
Hydrocodone bitartrate
Hydrocodone bitartrate is approved as 3 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VANTRELA ER · NDA 207975
3
Brand (NDA)
2
Generics (ANDA)
38
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VANTRELA ERRLD×5 | TEVA BRANDED PHARM | NDA 207975 | — | Jan 17, 2017 | |
| HYSINGLA ERRLD×7 | KNOA PHARMA | NDA 206627 | AB | Nov 20, 2014 | |
| ZOHYDRO ERRLD×6 | RECRO GAINESVILLE | NDA 202880 | — | Oct 25, 2013 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROCODONE BITARTRATE×7 | ALVOGEN | ANDA 208269 | AB | Mar 01, 2021 | |
| HYDROCODONE BITARTRATE×6 | ALVOGEN | ANDA 206986 | — | Jan 21, 2020 |
Listed patents (38)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9545380 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9095614 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492391 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9492390 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 11304909 | Aug 24, 2027 | in 1 yr 2 mo | U-1556 |
| 9084816 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9763933 | 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 |
| 9775809 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 11304908 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9486412 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9770416 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9095615 | Aug 24, 2027 | in 1 yr 2 mo | Product |
| 9216176 | Sep 13, 2027 | in 1 yr 3 mo | Product |
| 9572803 | Sep 13, 2027 | in 1 yr 3 mo | Product |
| 8445018 | Jul 31, 2029 | in 3 yr 2 mo | Product |
| 8808740 | Dec 21, 2031 | in 5 yr 7 mo | ProductU-1556 |
| 9861584 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9572779 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9750703 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9872837 | Dec 21, 2031 | in 5 yr 7 mo | Product |
| 9326982 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9339499 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10456393 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10028946 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9265760 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9433619 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10722511 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9610286 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9421200 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 9333201 | Jul 25, 2033 | in 7 yr 2 mo | U-1810 |
| 10322120 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 9713611 | Sep 12, 2034 | in 8 yr 4 mo | ProductU-55 |
| 9486451 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 9452163 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 10092559 | Sep 12, 2034 | in 8 yr 4 mo | U-55 |
| 9132096 | Sep 12, 2034 | in 8 yr 4 mo | Product |
Hydrocodone bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
