Viewing data from:

PRISTIQ

NDA

DESVENLAFAXINE SUCCINATE | N021992 | PF PRISM CV

3 strengths1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Expiring < 1yr (1)Today

2027

Today

8269040

Jul. 5, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Pfizer Inc. et al v. Zydus Pharmaceuticals USA Inc. et al 1:2012cv00808 2 patentsANDA 204003O-desmethylvenlafaxine succinate	D. Del.	2012-06-22	Terminated 2014-08-06	—
Pfizer Inc. et al v. Apotex Inc. et al 1:2012cv00809 1 patentANDA 204088O-desmethylvenlafaxine succinate	D. Del.	2012-06-22	Terminated 2014-07-25	—
Pfizer Inc. et al v. Mylan Pharmaceuticals Inc. et al 1:2012cv00812 1 patentANDA 20-4095O-desmethylvenlafaxine succinate	D. Del.	2012-06-22	Terminated 2014-08-01	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

62 trials from ClinicalTrials.gov, 52 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study Evaluating the Pharmacokinetics of Venlafaxine ER and Desvenlafaxine SR in Healthy Subjects NCT00329186	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	14	2006-05 → 2007-06
Study Evaluating the Effects of DVS SR and Paroxetine on the Pharmacokinetics of Desipramine in Healthy Subjects NCT00329147	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	20	2006-05 → 2006-06
The Effect Of Dose Titration And Dose Tapering On The Tolerability Of DVS SR In Women With Vasomotor Symptoms NCT00401245	Phase 3	Completed	Pfizer	500	2006-12 → 2008-01
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet NCT01443208	Phase 1	Completed	Pfizer	36	2011-11 → 2011-12
Desvenlafaxine vs. Placebo Treatment of Chronic Depression NCT01537068	Phase 4	Completed	New York State Psychiatric Institute	59	2012-02 → 2016-12
A Relative Bioavailability Food Effect Study of LY03005 NCT03822065	Phase 1	Completed	Luye Pharma Group Ltd.	34	2019-01-16 → 2019-02-16
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) In The Treatment Of Major Depressive Disorder NCT00384033	Phase 3	Completed	Pfizer	638	2006-09 → 2007-09
Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine NCT01527786	Phase 3	Completed	BC Women's Hospital & Health Centre	25	2010-11 → 2014-02
Relative Bioavailability (RBA) Study of LY03005 vs Pristiq®NCT03357796	Phase 1	Completed	Luye Pharma Group Ltd.	20	2017-11-27 → 2017-12-22
Study Evaluating Safety, Tolerability, and PK of DVS SR in Healthy Japanese Women NCT00397176	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer	32	2006-11 → 2007-02

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 7 NDCs

Highest NADAC/Unit

$14.00

per ea

Lowest NADAC/Unit

$13.95

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00008121030PRISTIQ ER 25 MG TABLET	$14.00	EA	Brand	$0.4459	2026-06-17
00008121101PRISTIQ ER 50 MG TABLET	$13.96	EA	Brand	$0.4248	2026-06-17
00008121114PRISTIQ ER 50 MG TABLET	$13.96	EA	Brand	$0.4248	2026-06-17
00008121130PRISTIQ ER 50 MG TABLET	$13.96	EA	Brand	$0.4248	2026-06-17
00008122230PRISTIQ ER 100 MG TABLET	$13.95	EA	Brand	$0.4205	2026-06-17
00008122201PRISTIQ ER 100 MG TABLET	$13.95	EA	Brand	$0.4205	2026-06-17
00008122214PRISTIQ ER 100 MG TABLET	$13.95	EA	Brand	$0.4205	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 14 NDCs (7 FSS, 7 Big4)

Lowest Price

$152.90

Highest Price

$1313.85

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00008-1210-30PRISTIQ 25MG	$437.96	FSS	Pfizer Inc.	06/30/2029
00008-1210-30PRISTIQ 25MG	$327.84	Big4	Pfizer Inc.	06/30/2029
00008-1222-01PRISTIQ	$1313.85	FSS	Pfizer Inc.	06/30/2029
00008-1222-01PRISTIQ	$983.48	Big4	Pfizer Inc.	06/30/2029
00008-1222-14PRISTIQ 100MG TAB,SA	$203.35	FSS	Pfizer Inc.	06/30/2029
00008-1222-14PRISTIQ 100MG TAB,SA	$152.90	Big4	Pfizer Inc.	06/30/2029

Showing 6 of 14 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Pristiq (2024)

Total Spending

$6.1M

Total Claims

7,562

Beneficiaries

1,470

Avg Cost/Unit

$13.98

Spending Trend

$13.4M(2019)→$10.7M(2020)→$9.4M(2021)→$7.8M(2022)→$6.6M(2023)→$6.1M(2024)

YoY Change:-5.1%

5yr CAGR:+0.8%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain20 active DMFs1 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

ZYDUS LIFESCIENCES LTDDESVENLAFAXINE SUCCINATE USP

DMF 254472012

WOCKHARDT LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 256562012

TAPI NL BVDESVENLAFAXINE SUCCINATE

DMF 257492012

LUPIN MANUFACTURING SOLUTIONS LTDDESVENLAFAXINE SUCCINATE

DMF 257512012

APOTEX INCDESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 257772012

MSN LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (FORM-1)

DMF 304372016

MACLEODS PHARMACEUTICALS LTDDESVENLAFAXINE SUCCINATE

DMF 309822017

MSN LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (FORM-II) [ROUTE CODE "SL"]

DMF 311572016

AURORE LIFE SCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE USP

DMF 344292019

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)DESVENLAFAXINE SUCCINATE MONOHYDRATE

DMF 370362022

HUBEI HAOSUN PHARMACEUTICAL CO LTDDESVENLAFAXINE SUCCINATE

DMF 372372022

HIKAL LTDDESVENLAFAXINE SUCCINATE USP

DMF 374262022

ATUL BIOSCIENCE LTDDESVENLAFAXINE SUCCINATE USP

DMF 375712022

AMI LIFESCIENCES PRIVATE LTDDESVENLAFAXINE SUCCINATE

DMF 380662023

HETERO DRUGS LTDDESVENLAFAXINE SUCCINATE

DMF 385512023

ZHEJIANG APELOA JIAYUAN PHARMACEUTICAL CO LTDDESVENLAFAXINE SUCCINATE

DMF 386242023

MEGAFINE PHARMA P LTDDESVENLAFAXINE SUCCINATE MONOHYDRATE USP (NON-STERILE DRUG SUBSTANCE)

DMF 408392025

COHANCE LIFESCIENCES LTDDESVENLAFAXINE SUCCINATE

DMF 408462024

SNJ LABS PVT LTDDESVENLAFAXINE SUCCINATE USP

DMF 426392025

APITORIA PHARMA PRIVATE LIMITEDDESVENLAFAXINE SUCCINATE USP

DMF 438972026

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveDESVENLAFAXINE SUCCINATE HPMC PRELIMINARY MIX

DMF 257472012

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

30 letters from Drugs@FDA

Date	Submission	Document
Aug 22, 2023	SUPPL -51	View Letter (PDF)
Nov 12, 2021	SUPPL -47	View Letter (PDF)
Sep 21, 2021	SUPPL -48	View Letter (PDF)
Feb 8, 2018	SUPPL -42	View Letter (PDF)
Dec 27, 2017	SUPPL -46	View Letter (PDF)
Aug 26, 2016	SUPPL -43	View Letter (PDF)
Nov 14, 2014	SUPPL -39	View Letter (PDF)
Jul 21, 2014	SUPPL -40	View Letter (PDF)
Dec 24, 2013	SUPPL -37	View Letter (PDF)
Dec 13, 2013	SUPPL -31	View Letter (PDF)
Mar 15, 2013	SUPPL -36	View Letter (PDF)
Feb 19, 2013	SUPPL -33	View Letter (PDF)
Dec 11, 2012	SUPPL -34	View Letter (PDF)
Mar 12, 2012	SUPPL -30	View Letter (PDF)
Apr 13, 2011	SUPPL -22	View Letter (PDF)
Mar 7, 2011	SUPPL -21	View Letter (PDF)
Feb 3, 2011	SUPPL -20	View Letter (PDF)
Jan 25, 2011	SUPPL -19	View Letter (PDF)
Oct 20, 2010	SUPPL -13	View Letter (PDF)
Sep 9, 2010	SUPPL -17	View Letter (PDF)
Jul 14, 2010	SUPPL -15	View Letter (PDF)
Feb 22, 2010	SUPPL -11	View Letter (PDF)
Jan 25, 2010	SUPPL -9	View Letter (PDF)
Jan 25, 2010	SUPPL -8	View Letter (PDF)
Nov 24, 2009	SUPPL -6	View Letter (PDF)
Nov 24, 2009	SUPPL -1	View Letter (PDF)
Nov 24, 2009	SUPPL -7	View Letter (PDF)
Apr 29, 2009	SUPPL -5	View Letter (PDF)
Feb 3, 2009	SUPPL -4	View Letter (PDF)
Mar 5, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

RLDAB

1 patent0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 29, 2008

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8269040	Jul 5, 2027	—	Yes	—	—	—

#002 — EQ 100MG BASE

RLDAB

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Feb 29, 2008

#003 — EQ 25MG BASE

RLDAB

1 patent0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Aug 20, 2014