CITALOPRAM HYDROBROMIDE - Generic Drug Details

What are the generic sources for citalopram hydrobromide and what is the scope of patent protection?

Citalopram hydrobromide is the generic ingredient in two branded drugs marketed by Almatica, Norvium Bioscience, Forest Labs, Aurobindo Pharma, Chartwell Molecular, Hetero Labs Ltd Iii, Hikma, Pharm Assoc, Biovail Labs Intl, Abbvie, Amneal Pharms Ny, Apotex, Aurobindo, Chartwell Rx, Cosette, Dr Reddys Labs Ltd, Epic Pharma, Epic Pharma Llc, Fosun Pharma, Glenmark Pharms Ltd, Heritage Pharma, Invagen Pharms, Jubilant Generics, Mylan, Natco Pharma Ltd, Roxane, Sun Pharm Inds Inc, Sun Pharm Industries, Taro, and Torrent Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-eight drug master file entries for citalopram hydrobromide. Forty-three suppliers are listed for this compound.

Summary for CITALOPRAM HYDROBROMIDE

US Patents:	0
Tradenames:	2
Applicants:	30
NDAs:	36
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	132
Clinical Trials:	12
Patent Applications:	2,710
Drug Prices:	Drug price trends for CITALOPRAM HYDROBROMIDE
Drug Sales Revenues:	Drug sales revenues for CITALOPRAM HYDROBROMIDE
What excipients (inactive ingredients) are in CITALOPRAM HYDROBROMIDE?	CITALOPRAM HYDROBROMIDE excipients list
DailyMed Link:	CITALOPRAM HYDROBROMIDE at DailyMed

See drug prices for CITALOPRAM HYDROBROMIDE

See drug sales revenues for CITALOPRAM HYDROBROMIDE

Recent Clinical Trials for CITALOPRAM HYDROBROMIDE

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

Sponsor	Phase
Otsuka Pharmaceutical Development & Commercialization, Inc.	Phase 3
Haining Health-Coming Biotech Co., Ltd.	Phase 2
Alphacait, LLC	Phase 2

See all CITALOPRAM HYDROBROMIDE clinical trials

Pharmacology for CITALOPRAM HYDROBROMIDE

Drug Class	Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Medical Subject Heading (MeSH) Categories for CITALOPRAM HYDROBROMIDE

Antidepressive Agents, Second-Generation

Serotonin Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CITALOPRAM HYDROBROMIDE

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

US Patents and Regulatory Information for CITALOPRAM HYDROBROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	CELEXA	citalopram hydrobromide	TABLET;ORAL	020822-002	Jul 17, 1998	AB	RX	Yes	No
Taro	CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077278-003	Mar 22, 2006		DISCN	No	No
Mylan	CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077042-003	Nov 5, 2004	AB	RX	No	No
Invagen Pharms	CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077534-003	Oct 3, 2006	AB	RX	No	No
Mylan	CITALOPRAM HYDROBROMIDE	citalopram hydrobromide	TABLET;ORAL	077042-001	Nov 5, 2004	AB	RX	No	No
Abbvie	CELEXA	citalopram hydrobromide	TABLET;ORAL	020822-001	Apr 27, 2000	AB	RX	Yes	No

CITALOPRAM HYDROBROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Citalopram Hydrobromide

Introduction to Citalopram Hydrobromide

Citalopram hydrobromide, commonly known by the brand name Celexa, is an antidepressant medication belonging to the selective serotonin reuptake inhibitor (SSRI) class. It is primarily used to treat depression, anxiety disorders, and other mental health conditions.

Global Market Size and Growth

The global market for citalopram hydrobromide has been experiencing significant fluctuations and growth. As of 2023, the global market size for citalopram hydrobromide was estimated at approximately USD 2.5 billion. It is projected to reach around USD 4.1 billion by 2032, indicating a substantial growth trajectory[4].

Market Trends and Drivers

Rising Mental Health Disorders

The primary driver of the citalopram hydrobromide market is the increasing prevalence of mental health disorders. According to the World Health Organization (WHO), about 264 million people worldwide suffered from depression in 2020. This rising trend in mental health issues is expected to continue driving the demand for antidepressant medications like citalopram hydrobromide[3].

COVID-19 Impact

The COVID-19 pandemic has significantly impacted the mental health landscape, leading to an increased demand for antidepressants. The pandemic-induced stress and anxiety have elevated the need for medications like citalopram hydrobromide, contributing to market growth[3].

Market Restraints and Challenges

Side Effects and Safety Concerns

One of the major restraints on the growth of the citalopram hydrobromide market is the associated side effects. Common side effects include nausea, sleeplessness, sweating, dry mouth, and drowsiness. More severe side effects, such as excessive bleeding, seizures, and vision issues, also pose significant risks. Additionally, citalopram hydrobromide can cause QTc prolongation, a condition associated with serious cardiac risks, which limits its use in certain patient populations[2][3].

Regulatory and Dosage Limitations

The use of citalopram hydrobromide is subject to strict dosage guidelines due to its potential to cause QTc prolongation. The maximum recommended dose is 40 mg/day, and it is contraindicated in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia. These limitations can restrict market growth[2].

Regional Analysis

The global citalopram hydrobromide market is segmented across various regions, with different regions exhibiting different growth patterns. The market is expected to be dominated by regions with high prevalence rates of mental health disorders and strong healthcare systems. For instance, the North American and European markets are significant due to their advanced healthcare infrastructure and higher awareness of mental health issues[1].

Competitor Analysis

The antidepressant market, including citalopram hydrobromide, is highly competitive with several key players. Companies like Allergan, which acquired Aptinyx to gain insights into NMDA receptor modulation for depression treatment, are actively involved in research and development to enhance their market position. The competitive landscape is driven by innovation, regulatory approvals, and strategic acquisitions[3].

Segment Analysis

The citalopram hydrobromide market can be segmented based on type, application, and geography.

Type

The market is segmented into different types based on the formulation of citalopram hydrobromide, such as tablets and oral solutions. Both formulations are bioequivalent, offering similar efficacy and safety profiles[2].

Application

Citalopram hydrobromide is used to treat various mental health conditions, including depression, anxiety disorders, obsessive-compulsive disorder (OCD), and post-traumatic stress disorder (PTSD). The application segment is crucial as it determines the demand and usage patterns of the drug[3].

Financial Projections

The financial trajectory of the citalopram hydrobromide market is promising, with a projected growth from USD 2.5 billion in 2023 to approximately USD 4.1 billion by 2032. This growth is driven by increasing demand due to rising mental health issues and the ongoing need for effective antidepressant medications[4].

CAGR and Growth Rate

The compound annual growth rate (CAGR) for the global antidepressants market, which includes citalopram hydrobromide, is expected to be around 7.6% from 2021 to 2025. This growth rate indicates a steady and significant expansion of the market over the forecast period[3].

ESG and Regulatory Analysis

The environmental, social, and governance (ESG) factors play a crucial role in the pharmaceutical industry. For citalopram hydrobromide, regulatory compliance is paramount. The drug is subject to strict regulations regarding its use, dosage, and safety monitoring. Compliance with these regulations is essential for maintaining market presence and ensuring patient safety[1].

Technological Trends

Advancements in pharmaceutical technology, such as improved drug delivery systems and personalized medicine, are expected to influence the citalopram hydrobromide market. However, the core formulation of citalopram hydrobromide remains relatively stable, with ongoing research focusing more on its applications and safety profiles rather than technological innovations in the drug itself[1].

SWOT Analysis

Strengths

• Established brand presence
• Wide range of applications in mental health
• Strong demand due to rising mental health issues

Weaknesses

• Associated side effects and safety concerns
• Dosage limitations and contraindications
• High competition in the antidepressant market

Opportunities

• Growing awareness of mental health
• Expanding healthcare infrastructure in emerging markets
• Potential for new applications and indications

Threats

• Regulatory changes and strict guidelines
• Emergence of new and safer antidepressants
• Economic fluctuations affecting healthcare spending

Consumer Behavior Analysis

Consumer behavior in the context of citalopram hydrobromide is influenced by the increasing awareness of mental health issues and the willingness to seek medical help. Patients and healthcare providers are becoming more informed about the benefits and risks of antidepressant medications, which affects the demand and usage patterns of citalopram hydrobromide[1].

Key Takeaways

• The global citalopram hydrobromide market is expected to grow significantly, driven by rising mental health disorders and the ongoing need for effective antidepressants.
• The market is restrained by side effects, safety concerns, and regulatory limitations.
• Regional analysis indicates strong market presence in North America and Europe.
• The competitive landscape is driven by innovation and strategic acquisitions.
• Financial projections indicate a promising growth trajectory.

Frequently Asked Questions (FAQs)

1. What is the primary use of citalopram hydrobromide? Citalopram hydrobromide is primarily used to treat depression, anxiety disorders, and other mental health conditions.

2. What are the common side effects of citalopram hydrobromide? Common side effects include nausea, sleeplessness, sweating, dry mouth, and drowsiness. More severe side effects can include excessive bleeding, seizures, and vision issues.

3. What is the maximum recommended dose of citalopram hydrobromide? The maximum recommended dose of citalopram hydrobromide is 40 mg/day due to the risk of QTc prolongation.

4. How has the COVID-19 pandemic affected the demand for citalopram hydrobromide? The COVID-19 pandemic has increased the demand for antidepressant medications like citalopram hydrobromide due to elevated stress and anxiety levels.

5. What is the projected market size of citalopram hydrobromide by 2032? The global market size for citalopram hydrobromide is projected to reach approximately USD 4.1 billion by 2032.

Cited Sources:

1. Cognitivemarketresearch.com: Citalopram Hydrobromide Market Report 2024 (Global Edition)
2. Accessdata.fda.gov: Celexa (citalopram hydrobromide) 10 mg, 20 mg, and 40 mg tablets
3. Businesswire.com: Global Antidepressants Market Report 2021: COVID-19 Causes a Surge in Demand for Antidepressant Drugs as Mental Health Problems Rise
4. Dataintelo.com: Citalopram Hydrobromide Market Research Report 2032
5. Jamanetwork.com: Lack of Efficacy of Citalopram in Children With Autism Spectrum Disorders