FDA Orange Book · active-ingredient family
Doxylamine succinate; pyridoxine hydrochloride
Doxylamine succinate; pyridoxine hydrochloride is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BONJESTA · NDA 209661
3
Brand (NDA)
5
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, delayed release, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BONJESTARLD | DUCHESNAY | NDA 209661 | — | Nov 07, 2016 | |
| DICLEGISRLD | DUCHESNAY | NDA 021876 | AB | Apr 08, 2013 | |
| BENDECTIN | SANOFI AVENTIS US | NDA 010598 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | BIONPHARMA | ANDA 217000 | AB | Aug 04, 2023 | |
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | ACTAVIS LABS FL INC | ANDA 212472 | — | Mar 01, 2022 | |
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | PHARMOBEDIENT | ANDA 207825 | AB | Jul 06, 2020 | |
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | PH HEALTH | ANDA 208518 | AB | Dec 06, 2017 | |
| DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | ACTAVIS LABS FL INC | ANDA 205811 | AB | Aug 19, 2016 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9937132 | Feb 18, 2033 | in 6 yr 9 mo | ProductU-1382 |
| 9375404 | Feb 18, 2033 | in 6 yr 9 mo | ProductU-1382 |
| 9526703 | Feb 18, 2033 | in 6 yr 9 mo | ProductU-1382 |
| 9089489 | Feb 18, 2033 | in 6 yr 9 mo | ProductU-1382 |
Doxylamine succinate; pyridoxine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
