LEXAPRO Drug Patent Profile

Which patents cover Lexapro, and what generic alternatives are available?

Lexapro is a drug marketed by Abbvie and is included in two NDAs.

The generic ingredient in LEXAPRO is escitalopram oxalate. There are twenty-six drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lexapro

A generic version of LEXAPRO was approved as escitalopram oxalate by AMNEAL PHARMS on March 14^th, 2012.

Summary for LEXAPRO

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	161
Patent Applications:	698
Drug Prices:	Drug price information for LEXAPRO
Drug Sales Revenues:	Drug sales revenues for LEXAPRO
What excipients (inactive ingredients) are in LEXAPRO?	LEXAPRO excipients list
DailyMed Link:	LEXAPRO at DailyMed

See drug prices for LEXAPRO

See drug sales revenues for LEXAPRO

Recent Clinical Trials for LEXAPRO

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

Sponsor	Phase
National Center for Complementary and Integrative Health (NCCIH)	Phase 2/Phase 3
University of Michigan	Phase 2/Phase 3
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2/Phase 3

See all LEXAPRO clinical trials

Pharmacology for LEXAPRO

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for LEXAPRO

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 LEXAPRO

LEXAPRO is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002		DISCN	Yes	No
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	AB	RX	Yes	Yes
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-001	Aug 14, 2002	AB	RX	Yes	No
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	AB	RX	Yes	No

Expired US Patents for LEXAPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	RE34712*PED
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	6,916,941*PED
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-003	Aug 14, 2002	7,420,069*PED
Abbvie	LEXAPRO	escitalopram oxalate	SOLUTION;ORAL	021365-001	Nov 27, 2002	RE34712*PED
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	RE34712*PED
Abbvie	LEXAPRO	escitalopram oxalate	TABLET;ORAL	021323-002	Aug 14, 2002	7,420,069*PED

International Patents for LEXAPRO

See the table below for patents covering LEXAPRO around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	259989
Peru	20030304	COMPOSICION CRISTALINA QUE CONTIENE ESCITALOPRAM
Japan	4971477
Eurasian Patent Organization	200400243
Norway	328346
Denmark	1522539

Supplementary Protection Certificates for LEXAPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0347066	SZ 42/2002	Austria
0347066	C300155	Netherlands		PRODUCT NAME: ESCITALOPRAM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER ESCITALOPRAMOXALAAT; REGISTRATION NO/DATE: RVG 30490 - RVG 30497 20040427
0347066	90999	Luxembourg
0347066	42/2002	Austria		PRODUCT NAME: ESCITALOPRAM UND DESSEN NICHT-TOXISCHE SAEUREADDITIONSSALZE; NAT. REGISTRATION NO/DATE: 1-24549, 1-24550, 1-24551, 1-24552 20020618; FIRST REGISTRATION: SE 17084, 17085, 17086,17087 20011207
0347066	SPC/GB02/049	United Kingdom		PRODUCT NAME: ESCITALOPRAM OXALATE; REGISTERED: SE 17084/85/86/87 20011207; UK PL 13761/0008 20020610; UK PC 13761/0009 20020610; UK PL 13761/0010 20020610; UK PL 13761/0011 20020610; UK PL 13761/0012 20020610; UK PL 13761/0013 20020610; UK PL 13761/00014 20020610; UK PL 13761/0015 20020610
0347066	2002C/039	Belgium		PRODUCT NAME: ESCITALOPRAM. OXALAT. (INN) ESCITALOPRAM; NATL. REGISTRATION NO/DATE: 7004 IE10 F 3 20020729; FIRST REGISTRATION: SE 17084 20011207

LEXAPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lexapro (Escitalopram)

Introduction to Lexapro (Escitalopram)

Lexapro, known generically as escitalopram, is a selective serotonin reuptake inhibitor (SSRI) widely used in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD). Here, we delve into the market dynamics and financial trajectory of this significant pharmaceutical product.

Market Size and Forecast

The escitalopram market is projected to experience substantial growth. As of 2023, the market size was valued at USD 1.2 billion and is expected to reach USD 1.9 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.7% from 2024 to 2031[1].

Drivers of Market Growth

Several factors are driving the growth of the escitalopram market:

Prevalence of Mental Health Disorders

The increasing incidence of depression, anxiety, and related disorders is a significant driver. Higher awareness and diagnosis rates of these conditions contribute to the growing demand for medications like escitalopram[1].

Aging Population

As the global population ages, the prevalence of mental health issues such as depression and anxiety tends to rise, driving demand for antidepressant medications[1].

Increased Awareness and Diagnosis

Greater awareness about mental health and improved diagnostic capabilities lead to more people being diagnosed and treated for conditions that escitalopram can address[1].

Advancements in Healthcare

Innovations in healthcare, including better diagnostic tools and treatment options, increase the effectiveness of escitalopram and its usage[1].

Insurance Coverage and Healthcare Access

Better insurance coverage and access to healthcare services can make escitalopram more accessible to patients, supporting market growth[1].

Pharmaceutical Innovations

New formulations, extended-release versions, or combination therapies involving escitalopram can expand its market potential[1].

Regional Market Dynamics

The escitalopram market is diversified across various regions:

North America

North America, particularly the United States, is a significant market due to the high prevalence of mental health issues and substantial healthcare spending. Established distribution channels and high awareness regarding mental health treatments support this growth[1].

Europe

Europe holds a strong market presence, with countries like Germany, France, and the UK demonstrating robust demand bolstered by rising healthcare initiatives and increasing acceptance of psychiatric medications[1].

Asia-Pacific

Rapid urbanization and growing recognition of mental health issues are driving demand in the Asia-Pacific region, although market penetration may vary due to differing healthcare regulations and economic conditions[1].

Middle East and Africa

This region is influenced by a mix of cultural factors and varying healthcare policies, resulting in emerging opportunities for growth, especially in urbanized areas[1].

Latin America

Latin America is witnessing an uptrend due to rising economic conditions in countries like Brazil and Argentina, leading to improved access to healthcare and mental health medications[1].

Key Players

Several major pharmaceutical companies are key players in the escitalopram market:

• Lundbeck: Known for its strong portfolio, including escitalopram under the brand name Cipralex/Lexapro[1][2].
• Forest Laboratories: Another significant player, although the brand has undergone changes in ownership over the years.
• Hikma Pharmaceuticals, Teva Pharmaceutical Industries, Mylan N.V., Aurobindo Pharma, Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, Zydus Cadila, and Perrigo Company plc are also major players in this market[1].

Financial Performance

Lundbeck, one of the primary manufacturers of escitalopram, has shown robust financial performance. For instance, in the first quarter of 2022, Lundbeck's revenue reached DKK 4,372 million, with strategic brands like Brintellix/Trintellix and Rexulti/Rxulti contributing significantly to this growth. Although the revenue from escitalopram itself is not separately detailed in this report, the overall performance of Lundbeck's portfolio indicates a strong financial trajectory for its psychiatric medications[2].

Challenges and Restraints

Despite the growth potential, the escitalopram market faces several challenges:

Generic Competition

The availability of generic versions of escitalopram can drive market competition and impact pricing dynamics, influencing market growth. Generic versions often lead to significant price reductions and decreased revenue for brand-name versions[1].

Adverse Effects and Safety Concerns

Side effects such as nausea, sleep disturbances, sexual dysfunction, and weight gain can limit the use of escitalopram. There are also concerns about its association with increased risk of suicidal thoughts in some patients, particularly adolescents and young adults[1].

Regulatory Challenges

Changing regulations and stricter guidelines for antidepressants can impact market dynamics. Regulatory scrutiny regarding safety, efficacy, and marketing practices can affect the availability and promotion of escitalopram[1].

Market Saturation

The market for SSRIs is quite saturated with several other options available, which can limit the growth potential for escitalopram as patients and doctors have multiple alternatives to choose from[1].

Cost-Effectiveness and Pharmacoeconomic Analysis

Pharmacoeconomic studies have shown that escitalopram has a cost-effectiveness and cost-utility advantage over other SSRIs and SNRIs. For instance, cost-effectiveness ratios for escitalopram ranged from Euro 871 to Euro 2598 per successfully treated patient over 6 months in Western Europe[5].

Competitive Landscape

The competitive landscape is intense, with multiple players offering both branded and generic versions of escitalopram. The market is characterized by Porter’s five forces analysis, which includes the threat of new entrants, the threat of substitute products, the bargaining power of buyers, the bargaining power of suppliers, and the intensity of rivalry among competitors[1].

Value Chain Analysis

The value chain analysis for escitalopram includes various stages such as raw material procurement, manufacturing, distribution, and retail. Each stage adds value to the product, and understanding these stages is crucial for market players to optimize their operations and maintain competitiveness[4].

Market Segmentation

The market is segmented based on product type (branded vs. generic), distribution channels (hospital pharmacies, retail pharmacies, online pharmacies), and geographical regions. This segmentation helps in understanding the specific dynamics and opportunities in different segments[1][4].

Geopolitical Impact

Geopolitical factors, including changes in healthcare policies and economic conditions, can significantly impact the escitalopram market. For example, improvements in economic conditions in emerging markets can lead to increased access to healthcare and mental health medications[4].

Key Takeaways

• The escitalopram market is expected to grow at a CAGR of 6.7% from 2024 to 2031.
• Key drivers include the prevalence of mental health disorders, an aging population, increased awareness and diagnosis, advancements in healthcare, and better insurance coverage.
• Regional dynamics vary, with North America and Europe being significant markets.
• Major players include Lundbeck, Forest Laboratories, and several generic manufacturers.
• Challenges include generic competition, adverse effects, regulatory challenges, and market saturation.
• Escitalopram has shown cost-effectiveness and cost-utility advantages in pharmacoeconomic analyses.

FAQs

What is the projected market size of escitalopram by 2031?

The escitalopram market is projected to reach USD 1.9 billion by 2031[1].

Which regions are the most significant for the escitalopram market?

North America, particularly the United States, and Europe are the most significant regions for the escitalopram market[1].

What are the main drivers of the escitalopram market growth?

The main drivers include the prevalence of mental health disorders, an aging population, increased awareness and diagnosis, advancements in healthcare, and better insurance coverage[1].

Who are the key players in the escitalopram market?

Key players include Lundbeck, Forest Laboratories, Hikma Pharmaceuticals, Teva Pharmaceutical Industries, Mylan N.V., Aurobindo Pharma, Sun Pharmaceutical Industries, Dr. Reddy’s Laboratories, Zydus Cadila, and Perrigo Company plc[1].

What are the major challenges facing the escitalopram market?

Major challenges include generic competition, adverse effects and safety concerns, regulatory challenges, and market saturation[1].

How cost-effective is escitalopram compared to other antidepressants?

Escitalopram has shown cost-effectiveness and cost-utility advantages over other SSRIs and SNRIs in pharmacoeconomic analyses[5].

Sources

1. Verified Market Research: Escitalopram Market Size, Trends, Growth, & Forecast.
2. Lundbeck: Corporate Release - Lundbeck.
3. DataIntelo: Lexapro Sales Market Report | Global Forecast From 2023 To 2032.
4. Profshare Market Research: Escitalopram Market Market Analysis, Growth and Forecast 2016.
5. PubMed: Escitalopram: a pharmacoeconomic review of its use in depression.