Desvenlafaxine Succinate Hydrate

Desvenlafaxine succinate hydrate was approved by the U.S. Food and Drug Administration (FDA) on February 29, 2008.It was developed by Pfizer, then marketed as Pristiq® by Pfizer in the US.

The exact mechanism of the antidepressant action of Desvenlafaxine is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non-clinical studies have shown that Desvenlafaxine is a potent and selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is indicated for the treatment of major depressive disorder (MDD).

Pristiq® is available as extended release tablet for oral use, containing 50 mg or 100 mg of free Desvenlafaxine. The recommended dose is 50 mg once daily with or without food.

Index：

General Information

Update Date：2016-03-08

Drug Name：
Desvenlafaxine Succinate Hydrate
Research Code：
DVS-233
Trade Name：
Pristiq®
MOA：
Serotonin and norepinephrine reuptake inhibitor (SNRI)
Indication：
Major depressive disorder (MDD)
Status：
Approved
Company：
Pfizer (Originator)
Sales：
$715 Million (Y2015);
$737 Million (Y2014);;
$698 Million (Y2013);;
$630 Million (Y2012);;
$577 Million (Y2011);
ATC Code：
N06AX23
Approved Countries or Area

Update Date：2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2008-02-29 Marketing approval Pristiq Major depressive disorder (MDD) Tablet, Extended release Eq. 50 mg/100 mg Desvenlafaxine Pfizer Priority
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Chemical Structure

Update Date：2015-09-16

Molecular Weight 399.48
Formula C16H25NO2 • C4H6O4 • H2O
CAS No. 93413-62-8 (Desvenlafaxine );
386750-22-7 (Desvenlafaxine Succinate Monohydrate);
Chemical Name RS-4-[2-dimethylamino-1-(1-hydroxycyclohexyl)ethyl]phenol succinate monohydrate
Desvenlafaxine （Free Acid/Base）Parameters：
MW HD HA FRB* PSA* cLogP*
263.38 2 3 6 43.7 1.741±0.261
*：Calculated by ACD/Labs software V11.02.
Related Patents

Update Date：2015-08-31

No. Major Technical Classification Publication No. Patent No. Legal Status Filling Date Estimated Expiry Date
1 Salt CN1501909A CN100567253C Granted 2002/2/11 2022/2/11
2 Preparation CN101671260A Withdrawn 2002/2/11
3 Combination CN1705474A Withdrawn 2003/10/15
4 Combination CN1705484A Withdrawn 2003/10/15
5 Combination CN101146539A Withdrawn 2006/2/16
6 Formulation CN101304734A Withdrawn 2006/9/6
7 Combination CN101410112A Withdrawn 2007/3/23
8 Others CN101528667A Withdrawn 2007/10/24
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Synthesis & Impurities

Update Date：2015-12-25


1. US4535186.

2. WO2008093142 / US2010076086.

3. WO2002064543 / US20030045583.

4. WO2003048104 / US20030105358.

5. WO2003103603 / US20030236309.

6. J. Med. Chem. 1990, 33, 2899-2905.


1. WO2008013990 / US20080183016.


1. WO2008015584 / US20100121108.

2. WO2009034434.

3. WO2009053731 / US20110118357.

4. US20110098506.

5. WO2009009665A2 / US20100210719.


1. WO2008013993.


1. WO2009084037.


1. WO2008013994 / US20080177110.

Impurity database is being updated！