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, Intellipharmaceutics, Lupin Ltd, Norvium Bioscience, Rubicon, Yichang Humanwell, Zydus Pharms, and Pf Prism Cv, and is included in eleven 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-two suppliers are listed for this compound.

Summary for DESVENLAFAXINE SUCCINATE

International Patents:	22
US Patents:	1
Tradenames:	2
Applicants:	10
NDAs:	11
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	40
Patent Applications:	588
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
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.	Phase 3
Korea Cancer Center Hospital	Phase 4
Seoul National University 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
Norvium Bioscience	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204095-001	Jun 29, 2015		DISCN	No	No
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-002	Jun 29, 2015	AB	RX	No	No
Alembic	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204003-003	Sep 14, 2018	AB	RX	No	No
Yichang Humanwell	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	210014-001	Oct 1, 2018	AB	RX	No	No
Lupin Ltd	DESVENLAFAXINE SUCCINATE	desvenlafaxine succinate	TABLET, EXTENDED RELEASE;ORAL	204172-001	Jun 29, 2015	AB	RX	No	No

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	021992-002	Feb 29, 2008
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	021992-002	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	021992-001	Feb 29, 2008

International Patents for DESVENLAFAXINE SUCCINATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2133325
European Patent Office	1905757
Australia	4062700
World Intellectual Property Organization (WIPO)	0059851
Australia	782092

DESVENLAFAXINE SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Desvenlafaxine Succinate

Introduction

Desvenlafaxine succinate, marketed under the brand name PRISTIQ, is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) approved by the U.S. Food and Drug Administration (FDA) in 2008 for the treatment of major depressive disorder (MDD) in adults. Here, we will delve into the market dynamics and financial trajectory of this medication.

Clinical Efficacy and Approval

Desvenlafaxine's efficacy was established in four 8-week, randomized, double-blind, placebo-controlled studies involving adult outpatients with MDD. These studies demonstrated that desvenlafaxine was more effective than placebo in improving depressive symptoms as measured by the Hamilton Rating Scale for Depression (HAM-D17) and the Clinical Global Impressions-Improvement (CGI-I) scale[5].

Market Positioning

Competitive Landscape

Desvenlafaxine competes in the antidepressant market, which includes other SNRIs like venlafaxine and duloxetine, as well as selective serotonin reuptake inhibitors (SSRIs). However, desvenlafaxine has some unique characteristics that differentiate it from other antidepressants. It has a more predictable pharmacokinetic profile and a lower risk of drug-drug interactions due to its metabolic pathway[5].

Economic Evaluation

Studies have shown that desvenlafaxine is a cost-effective option for the treatment of MDD, particularly in patients who have not responded to first-line treatments. In a study conducted in Spain, desvenlafaxine was found to be clinically similar in effectiveness but less costly compared to a weighted average of duloxetine and venlafaxine. This resulted in lower drug and event management costs, leading to an overall cost reduction for the healthcare system[3].

Financial Performance

Revenue and Sales

Since its approval in 2008, PRISTIQ has generated significant revenue for Pfizer. Although specific annual sales figures are not provided in the sources, the drug's market presence and prescription rates indicate a substantial financial impact. The cost-effectiveness and clinical efficacy of desvenlafaxine contribute to its financial performance by reducing healthcare costs and improving patient outcomes.

Cost-Benefit Analysis

The economic evaluation of desvenlafaxine highlights its cost-benefit profile. By reducing the number of discontinuations and increasing the number of depression-free days, desvenlafaxine offers a more economical option for second-line treatment of MDD. This translates into lower overall costs for healthcare systems, making it an attractive choice for both patients and payers[3].

Safety and Tolerability

Adverse Reactions

The safety profile of desvenlafaxine is comparable to other SNRIs. Common adverse reactions include nausea, dizziness, and vomiting, which are generally more frequent during the initial weeks of treatment. The recommended starting dose of 50 mg/day, with the option of every-other-day dosing to mitigate adverse effects, helps in managing these side effects[5].

Safety Monitoring

Patients on desvenlafaxine require regular monitoring of blood pressure due to potential increases, and caution is advised in patients with pre-existing hypertension or cardiovascular conditions. Additionally, there is a risk of serotonin syndrome, especially when co-administered with other serotonergic agents, and a potential for bleeding events when used with anticoagulants[1].

Market Expansion and Limitations

Pediatric Use

Despite efforts to expand its use to pediatric patients, a Phase 3 study evaluating desvenlafaxine in children and adolescents with MDD did not meet its primary objective of demonstrating superior efficacy compared to placebo. This limits the drug's market to adult patients only[1].

Specific Populations

Desvenlafaxine has shown efficacy in specific populations, such as perimenopausal and postmenopausal women with MDD. Pooled analysis from clinical trials indicated significant improvements in depressive symptoms and disability scores in these subgroups[4].

Long-Term Efficacy

Relapse Prevention

Studies have demonstrated that desvenlafaxine is effective in preventing relapse in patients with MDD. In longer-term trials, patients receiving continued desvenlafaxine treatment experienced statistically significantly longer times to relapse compared to those on placebo[2].

Regulatory Environment

FDA Approval and Post-Marketing Commitments

Desvenlafaxine was approved under the FDA's regulatory framework, and subsequent studies, including those in pediatric populations, were conducted as part of post-marketing commitments. The FDA's Complete Response Letter regarding the application for treating vasomotor symptoms in postmenopausal women did not impact its approval for MDD treatment[1][4].

Key Takeaways

• Clinical Efficacy: Desvenlafaxine has been proven effective in treating MDD in adults through multiple clinical trials.
• Cost-Effectiveness: It offers a cost-effective option for second-line treatment, reducing healthcare costs.
• Safety Profile: The drug has a manageable safety profile with common adverse reactions such as nausea and dizziness.
• Market Limitations: Its use is limited to adult patients due to lack of efficacy in pediatric trials.
• Long-Term Efficacy: Desvenlafaxine is effective in preventing relapse in patients with MDD.

FAQs

Q: What is desvenlafaxine succinate used for?

A: Desvenlafaxine succinate, marketed as PRISTIQ, is used for the treatment of major depressive disorder (MDD) in adults.

Q: How does desvenlafaxine compare to other antidepressants?

A: Desvenlafaxine has a more predictable pharmacokinetic profile and lower risk of drug-drug interactions compared to other SNRIs like venlafaxine and duloxetine.

Q: Is desvenlafaxine effective in pediatric patients?

A: No, a Phase 3 study did not demonstrate superior efficacy of desvenlafaxine in pediatric patients with MDD.

Q: What are the common adverse reactions associated with desvenlafaxine?

A: Common adverse reactions include nausea, dizziness, and vomiting, particularly during the initial weeks of treatment.

Q: Is desvenlafaxine cost-effective?

A: Yes, desvenlafaxine has been shown to be cost-effective, especially as a second-line treatment option, by reducing healthcare costs and increasing depression-free days.

Sources

1. Pfizer Reports Top Line Results from a Phase 3 Study Evaluating Desvenlafaxine Succinate Sustained-Release Formulation in Pediatric Patients with Major Depressive Disorder. Pfizer.
2. PRISTIQ® (desvenlafaxine succinate) Clinical Studies Patient. Pfizer Medical Information.
3. Economic evaluation of desvenlafaxine in the treatment of major depressive disorder. PubMed.
4. A pooled analysis of the efficacy of desvenlafaxine for the treatment of major depressive disorder in perimenopausal and postmenopausal women. PubMed.
5. Desvenlafaxine for depression. Current Psychiatry.