DESVENLAFAXINE SUCCINATE - Generic Drug Details

What are the generic drug sources for desvenlafaxine succinate and what is the scope of freedom to operate?

Desvenlafaxine succinate is the generic ingredient in two branded drugs marketed by Actavis Labs Fl, Alembic, Hikma, Lupin Ltd, Macleods Pharms Ltd, Pharmobedient, Platinum, Rubicon Research, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in twelve NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Desvenlafaxine succinate has twenty-two patent family members in sixteen countries.

There are eleven drug master file entries for desvenlafaxine succinate. Twenty suppliers are listed for this compound.

Summary for DESVENLAFAXINE SUCCINATE

International Patents:	22
US Patents:	1
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	97
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DESVENLAFAXINE SUCCINATE
What excipients (inactive ingredients) are in DESVENLAFAXINE SUCCINATE?	DESVENLAFAXINE SUCCINATE excipients list
DailyMed Link:	DESVENLAFAXINE SUCCINATE at DailyMed

Recent Clinical Trials for DESVENLAFAXINE SUCCINATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Jiangsu Province Nanjing Brain Hospital	NA
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Korea Cancer Center Hospital	Phase 4

See all DESVENLAFAXINE SUCCINATE clinical trials

Pharmacology for DESVENLAFAXINE SUCCINATE

Drug Class	Serotonin and Norepinephrine Reuptake Inhibitor
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for DESVENLAFAXINE SUCCINATE

Antidepressive Agents

Serotonin and Noradrenaline Reuptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DESVENLAFAXINE SUCCINATE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DESVENLAFAXINE SUCCINATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	25 mg	021992	1	2015-05-08
PRISTIQ	Extended-release Tablets	desvenlafaxine succinate	50 mg and 100 mg	021992	12	2012-02-29

US Patents and Regulatory Information for DESVENLAFAXINE SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204083-003	Feb 16, 2016	AB	RX	No	No
Hikma	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204083-002	Feb 16, 2016	AB	RX	No	No
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003-002	Jun 29, 2015	AB	RX	No	No
Zydus Pharms	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204020-002	Oct 11, 2017	AB	RX	No	No
Yichang Humanwell	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	220460-003	Mar 10, 2026	AB	RX	No	No
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-001	Jun 29, 2015	AB	RX	No	No
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008	AB	RX	Yes	No				Y

Expired US Patents for DESVENLAFAXINE SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-003	Aug 20, 2014
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-001	Feb 29, 2008
Pf Prism Cv	PRISTIQ	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	021992-002	Feb 29, 2008

International Patents for DESVENLAFAXINE SUCCINATE

Country	Patent Number	Title	Estimated Expiration
Czech Republic	20013607
Cyprus	1108202
Canada	2368083
European Patent Office	1165487
World Intellectual Property Organization (WIPO)	0059851
Hungary	0200898
Norway	20100496

Desvenlafaxine Succinate (DESVENLAFAXINE SUCCINATE): Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

What products and exposure drive the market for desvenlafaxine succinate?

Desvenlafaxine succinate is an oral, serotonin-norepinephrine reuptake inhibitor (SNRI) marketed for major depressive disorder (MDD). Commercial exposure is concentrated in branded originators plus follow-on generics, with revenue shaped by (1) ongoing patent/market-exclusivity timelines, (2) generic entry and price erosion, and (3) payer formularies and persistence dynamics in MDD.

Commercial revenue architecture (how the market tends to pay)

Revenue typically flows through three levers:

• Unit volume: prescriptions, refills, and patient persistence in MDD treatment
• Net price: driven by WAC-to-net rebates/discounts and generic discounts post-entry
• Portfolio displacement: competition with other SNRIs (and newer antidepressants), plus switching to agents with better payer positioning

Key competitive landscape

Desvenlafaxine competes in MDD against:

• Other SNRI classes (e.g., venlafaxine and duloxetine depending on geography and formulary)
• Broader antidepressant classes (SSRIs, atypicals)
• Adjacent depression pharmacotherapy that can displace SNRI share under formulary management

How do patent and exclusivity dynamics impact revenue trajectory?

Desvenlafaxine succinate’s financial trajectory is dominated by the shift from brand pricing to generic pricing after loss of exclusivity. For investors and R&D strategists, the market model is straightforward:

• Pre-exclusivity: brand price floors with formulary placement advantages
• Post-entry: sharp net-price declines and volume redistribution to lower-cost products
• Steady state generics: revenue stabilizes at lower margins, with growth dependent on total market size, adherence, and competitor displacement

What market dynamics typically govern desvenlafaxine succinate after generic entry?

1) Net price compression

After generic launches, net price typically declines faster than volume can compensate. The result is margin compression that persists even as prescription counts hold up in chronic MDD use.

2) Formulary tiering

Payers often move competing agents into lower tiers, shifting prescriptions. Brand persistence depends on:

• rebate competitiveness
• prior authorization requirements
• step therapy adoption
• exclusion status

3) Patient switching cycles

MDD treatment is chronic, but switching occurs due to tolerability, dose optimization, and payer policy. Switch rates tend to rise after new formulary events and around seasons with heightened prescribing and renewal activity.

What does a financial trajectory look like for desvenlafaxine succinate?

A defensible trajectory framework for desvenlafaxine succinate after exclusivity loss is:

• Brand revenue peak window: highest net price before generic pressure
• Generic entry inflection: volume share reallocates; net revenue declines
• Post-entry stabilization: unit volumes may remain sizeable while net sales trend lower due to pricing

Directionally expected post-generic path

• Net sales: declines following entry, then flattens
• Gross margin: compresses with generic-based competitive benchmarks
• Operating leverage: weakens as selling and payer contracting spend increases to defend share

Which financial KPIs matter most for investors tracking desvenlafaxine succinate?

Market and commercial KPIs

• Monthly prescriptions and TRx trend (volume health)
• Net price per script or average realized price trend (pricing power)
• Formulary position changes (tier moves, PA adoption)
• Share vs. class in MDD (SNRIs and broader antidepressant segments)

Corporate financial KPIs (for originators)

• Revenue contribution from the product line
• Selling, general and administrative spend efficiency
• Contracting costs and rebate intensity
• Cash flow resilience after margin compression

What data sources are used to quantify market share and revenue trajectory?

For a production-grade market and financial trajectory build, analysts generally triangulate:

• IMS/NPA sales and prescription datasets (or equivalent)
• Public company segment reporting (originator net sales)
• Generic launch calendars from regulatory filings
• Payer formulary and policy datasets for tiering and authorization events

What are the key business implications for R&D and investment decisions?

For R&D

• Product improvement and lifecycle strategies need to address payer friction and switching resistance.
• If considering line extensions, the value is usually measured against how much formularies will re-tier or reauthorize.

For investment

• The dominant risk is net price erosion after generic entry.
• Upside typically comes from volume resilience, new patient creation, or regained contracting strength against competitors.

What does the market outlook look like under standard dynamics for mature SNRI products?

For a mature, widely genericized MDD SNRI like desvenlafaxine succinate, the outlook typically depends on:

• stability of MDD patient demand
• intensity of generic competition
• payer contracting favorability between equivalent generics
• competitor share shifts in the SNRI and antidepressant classes

Key Takeaways

• Desvenlafaxine succinate’s revenue trajectory is structurally shaped by generic entry and net price compression, with unit volume unable to fully offset margin decline post-exclusivity.
• Market dynamics center on payer formularies, step therapy and prior authorization, and switching behavior in chronic MDD treatment.
• The investment and R&D lens should prioritize net price per script trends, TRx persistence, and formulary positioning, since these drive the post-entry financial path more than new demand creation.

FAQs

1) What drives revenue changes most for desvenlafaxine succinate after exclusivity?

Net price compression driven by generic competition, with volume often stabilizing slower than price declines.

2) Does desvenlafaxine succinate behave like a typical mature MDD brand post-generic?

Yes. Mature SNRI products usually see an inflection around generic entry and then a lower-margin steady state.

3) What payer policies most influence utilization?

Formulary tier placement, prior authorization, and step therapy requirements.

4) Which metric best predicts financial resilience?

Average realized net price per script and TRx/persistence together, because volume without pricing rarely sustains revenue.

5) What competition most affects desvenlafaxine succinate’s share?

Other antidepressants in MDD, especially SNRIs that can win formulary placement and switching.

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References

[1] American Society of Health-System Pharmacists. Desvenlafaxine: Drug Information. ASHP. https://www.ashp.org/
[2] U.S. Food and Drug Administration (FDA). Drug Approval Reports / Product Information for desvenlafaxine-containing products. https://www.fda.gov/Drugs/
[3] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (desvenlafaxine succinate entries). https://www.accessdata.fda.gov/scripts/cder/daf/
[4] EvaluatePharma. Global Use/Market and Sales Analytics (industry benchmarking for branded vs generic trajectories). https://www.evaluate.com/