Escitalopram oxalate - Generic Drug Details

What are the generic sources for escitalopram oxalate and what is the scope of patent protection?

Escitalopram oxalate is the generic ingredient in two branded drugs marketed by Norvium Bioscience, Amneal Pharms, Antrim Pharms Llc, Aurobindo Pharma Ltd, Chartwell Molecular, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Taro, Abbvie, Accord Hlthcare, Anima, Chartwell Rx, Dash Pharms, Graviti Pharms, Hikma Pharms, Invagen Pharms, Jubilant Cadista, Prinston Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Zydus Lifesciences, and is included in twenty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for escitalopram oxalate. Fifty suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for escitalopram oxalate

US Patents:	0
Tradenames:	2
Applicants:	21
NDAs:	25
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	21
Patent Applications:	1,042
Drug Prices:	Drug price trends for escitalopram oxalate
Drug Sales Revenues:	Drug sales revenues for escitalopram oxalate
What excipients (inactive ingredients) are in escitalopram oxalate?	escitalopram oxalate excipients list
DailyMed Link:	escitalopram oxalate at DailyMed

See drug prices for escitalopram oxalate

See drug sales revenues for escitalopram oxalate

Recent Clinical Trials for escitalopram oxalate

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

Sponsor	Phase
Sultan Qaboos University	Phase 4
National Institute on Aging (NIA)	Phase 4
NYU Langone Health	Phase 4

See all escitalopram oxalate clinical trials

Generic filers with tentative approvals for ESCITALOPRAM OXALATE

Applicant	Application No.	Strength	Dosage Form
		20MG	TABLET; ORAL
		10MG	TABLET; ORAL
		5MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for escitalopram oxalate

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for escitalopram oxalate

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

N06AB	Selective serotonin reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ESCITALOPRAM OXALATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LEXAPRO	Capsules	escitalopram oxalate	5 mg	021323	1	2005-08-17
LEXAPRO	Capsules	escitalopram oxalate	10 mg and 20 mg	021323	1	2005-03-30

US Patents and Regulatory Information for escitalopram oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharms	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	205619-001	May 17, 2017	AB	RX	No	No
Accord Hlthcare	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	202389-003	Sep 11, 2012	AB	RX	No	No
Amneal Pharms	ESCITALOPRAM OXALATE	escitalopram oxalate	SOLUTION;ORAL	202227-001	Mar 14, 2012	AA	RX	No	No
Aurobindo Pharma Ltd	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	090432-001	Sep 11, 2012	AB	RX	No	No
Accord Hlthcare	ESCITALOPRAM OXALATE	escitalopram oxalate	TABLET;ORAL	202389-002	Sep 11, 2012	AB	RX	No	No

Expired US Patents for escitalopram oxalate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002
Abbvie	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002

Escitalopram oxalate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Escitalopram Oxalate

Introduction

Escitalopram oxalate, a selective serotonin reuptake inhibitor (SSRI), is widely used to treat depression and generalized anxiety disorder (GAD). The market for this drug has been experiencing significant growth, driven by various factors. Here, we will delve into the market dynamics and financial trajectory of escitalopram oxalate.

Market Size and Growth Projections

The escitalopram oxalate market has witnessed substantial growth in recent years and is projected to continue this trend. According to market research reports, the global escitalopram oxalate market is expected to expand significantly from 2023 to 2031. The market size is anticipated to grow from its current value to reach several billion USD by the end of the forecast period, with a compound annual growth rate (CAGR) that indicates robust growth rates[1][3][4].

Segmentation and Analysis

The market is segmented based on several criteria, including type, application, and geographical regions.

Type

The market is segmented into tablets and oral solutions. Tablets, particularly those in 5mg, 10mg, and 20mg strengths, are a dominant segment. The oral solution, with a concentration of 1 mg/mL escitalopram base, also holds a significant share[2][3].

Application

Escitalopram oxalate is primarily used to treat depression, generalized anxiety disorder (GAD), panic disorder, and other psychiatric conditions. The treatment of depression is expected to remain a major driver of market growth, with this segment anticipated to expand at a significant CAGR throughout the forecast period[1][3][4].

Geographical Regions

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Asia-Pacific is expected to be a key region driving growth due to increasing healthcare expenditure and a growing patient population[1][3][4].

Market Drivers

Several factors are driving the growth of the escitalopram oxalate market:

Increasing Prevalence of Mental Health Disorders

The rising prevalence of depression and anxiety disorders globally is a significant driver. As awareness about mental health increases, more people are seeking treatment, which in turn boosts the demand for escitalopram oxalate[1][3][4].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, especially in developing regions, are enhancing access to psychiatric treatments. This expansion of healthcare services is contributing to the market's growth[1][3].

Economic Factors

The growing disposable income and increasing healthcare expenditure in various regions are also driving the market. Patients are more willing to invest in their health, leading to higher demand for effective treatments like escitalopram oxalate[1][3][4].

Market Restraints and Challenges

Despite the positive growth trajectory, there are several challenges and restraints:

Side Effects and Safety Concerns

Escitalopram oxalate can cause a range of side effects, including serotonin syndrome, hyponatremia, and increased risk of suicidal thoughts in young adults. These safety concerns can limit its adoption and affect market growth[2][5].

Regulatory Hurdles

Stringent regulatory requirements and the need for continuous clinical trials to ensure safety and efficacy can slow down market expansion. Additionally, the contraindication with monoamine oxidase inhibitors (MAOIs) and other medications adds complexity to its use[2].

Generic Competition

The presence of generic versions of escitalopram oxalate can reduce the market share of branded products. Generic competition often leads to price reductions, affecting the revenue of pharmaceutical companies[1][3][4].

Key Players and Competitive Landscape

The market for escitalopram oxalate is competitive, with several key players:

Major Pharmaceutical Companies

Companies like Xian-Janssen and JEWIM PHARMA are focusing on strengthening their product portfolios and expanding their business globally. These companies are investing in research and development to improve formulations and delivery methods, such as oral liquids, which are gaining popularity[4].

Financial Performance and Revenue Projections

The financial performance of the escitalopram oxalate market is robust, with significant revenue growth projected over the forecast period.

Revenue Growth

The market is expected to achieve substantial revenue growth, driven by increasing demand and expanding market segments. The revenue is projected to increase from its current value to several billion USD by 2031, with a CAGR that reflects strong market dynamics[1][3][4].

Regional Revenue Share

North America and Europe are currently the largest markets, but the Asia-Pacific region is expected to dominate the market in the future due to its large population and growing healthcare sector[1][3][4].

Technological and Regulatory Trends

Several technological and regulatory trends are influencing the market:

Innovative Formulations

The development of new formulations, such as oral liquids, is enhancing patient compliance and driving market growth. These innovations are particularly significant in regions where there is a preference for liquid formulations over tablets[4].

Regulatory Approvals

Regulatory approvals and updates play a crucial role in the market. For instance, the FDA's guidelines on the use of escitalopram oxalate, including dosages and contraindications, directly impact market dynamics[2].

Consumer Behavior and Preferences

Consumer behavior is another critical factor influencing the market:

Patient Compliance

Patients are increasingly seeking treatments that are easy to administer and have minimal side effects. The availability of escitalopram oxalate in various forms, such as tablets and oral solutions, caters to these preferences and enhances patient compliance[2][4].

Awareness and Education

Growing awareness about mental health and the importance of seeking treatment are driving more patients to opt for escitalopram oxalate. Educational campaigns and healthcare initiatives are contributing to this trend[1][3][4].

Key Takeaways

• The escitalopram oxalate market is expected to experience significant growth from 2023 to 2031.
• The market is driven by increasing prevalence of mental health disorders, advancements in healthcare infrastructure, and economic factors.
• Key challenges include side effects, safety concerns, regulatory hurdles, and generic competition.
• Major pharmaceutical companies are focusing on innovative formulations and expanding their global presence.
• The Asia-Pacific region is anticipated to dominate the market in the future.

Frequently Asked Questions (FAQs)

1. What are the primary applications of escitalopram oxalate? Escitalopram oxalate is primarily used to treat depression, generalized anxiety disorder (GAD), and panic disorder.

2. Which region is expected to dominate the global escitalopram oxalate market? The Asia-Pacific region is expected to dominate the global escitalopram oxalate market due to its large population and growing healthcare sector.

3. What are the common side effects of escitalopram oxalate? Common side effects include diarrhea, dry mouth, heartburn, sleepiness, and trouble sleeping. Serious side effects can include serotonin syndrome, hyponatremia, and increased risk of suicidal thoughts in young adults[2][5].

4. How does generic competition affect the escitalopram oxalate market? Generic competition can reduce the market share of branded products and lead to price reductions, affecting the revenue of pharmaceutical companies.

5. What are the key factors driving the growth of the escitalopram oxalate market? Key drivers include the increasing prevalence of mental health disorders, advancements in healthcare infrastructure, and economic factors such as growing disposable income and healthcare expenditure.

Sources:

1. Market Research Intellect. Escitalopram Oxalate API Market Size, Scope And Forecast Report.
2. FDA. Lexapro (escitalopram oxalate) - FDA.
3. Market Research Intellect. Escitalopram Oxalate Tablets Market Size, Scope And Forecast Report.
4. Cognitive Market Research. Escitalopram Oxalate Market Report 2024 (Global Edition).
5. Mayo Clinic. Escitalopram (oral route) - Mayo Clinic.