Doxepin hydrochloride - Generic Drug Details

What are the generic sources for doxepin hydrochloride and what is the scope of freedom to operate?

Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Pts Consulting, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pfizer, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Mylan, Actavis Elizabeth, Rk Pharma, Strides Pharma, and Currax, and is included in eighty-one NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has sixteen patent family members in four countries.

There is one drug master file entry for doxepin hydrochloride. Fifty suppliers are listed for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	16
Tradenames:	4
Applicants:	39
NDAs:	81
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	22
Patent Applications:	2,094
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxepin hydrochloride
What excipients (inactive ingredients) are in doxepin hydrochloride?	doxepin hydrochloride excipients list
DailyMed Link:	doxepin hydrochloride at DailyMed

Recent Clinical Trials for doxepin hydrochloride

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

Sponsor	Phase
Nanfang Hospital, Southern Medical University	N/A
E2Bio Life Sciences, LLC	Phase 1/Phase 2
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2

See all doxepin hydrochloride clinical trials

Pharmacology for doxepin hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for doxepin hydrochloride

Antidepressive Agents, Tricyclic

Histamine Antagonists

Sleep Aids, Pharmaceutical

Anatomical Therapeutic Chemical (ATC) Classes for doxepin hydrochloride

D04AX	Other antipruritics
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SILENOR	Tablets	doxepin hydrochloride	3 mg and 6 mg	022036	2	2010-09-16

US Patents and Regulatory Information for doxepin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Taro	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213063-005	Jul 1, 2020	AB	RX	No	No
Sun Pharm Industries	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071653-001	Feb 18, 1988		DISCN	No	No
Leading	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211619-002	Mar 9, 2021	AB	RX	No	No
Epic Pharma Llc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	210675-003	Oct 16, 2020	AB	RX	No	No
Aiping Pharm Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213474-004	Jul 28, 2020	AB	RX	No	No

Expired US Patents for doxepin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	6,217,909
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-006	Approved Prior to Jan 1, 1982	3,420,851
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	5,502,047
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	6,217,909
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	6,211,229

International Patents for doxepin hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2009537554
World Intellectual Property Organization (WIPO)	2007136845
Japan	2009537553
Japan	2016041757	睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT)
European Patent Office	2026792

Market Dynamics and Financial Trajectory for Doxepin Hydrochloride

Market Overview

The doxepin hydrochloride market is poised for significant growth over the forecast period, driven by several key factors. Here is a comprehensive look at the market dynamics and financial trajectory of this drug.

Drivers of Market Growth

Increasing Prevalence of Mental Health Disorders

The global rise in depression, anxiety disorders, and other mental health issues is a major driver for the doxepin hydrochloride market. According to the World Health Organization, depressive disorders affected 350 million people globally in 2012, and this number is expected to increase due to sedentary lifestyles and other factors[1].

Geriatric Population and Sleep Disorders

The increasing geriatric population and the prevalence of sleep disorders are also significant drivers. As the population ages, the demand for medications like doxepin hydrochloride, which is used to treat insomnia among other conditions, is likely to rise[1].

Favorable Reimbursement Policies

In developed countries, favorable reimbursement policies for medications and therapies contribute to the market's growth. These policies make treatments more accessible and affordable, thereby increasing demand[1].

Market Segmentation

Product Segmentation

The doxepin hydrochloride market is segmented into oral and topical forms. The oral form is widely used for treating major depressive disorder, anxiety disorders, and insomnia, while the topical form is used for conditions like chronic hives[1][4].

Application Segmentation

The market is segmented based on applications such as major depressive disorder, anxiety disorders, chronic hives, insomnia, and others. The major depressive disorder segment is expected to expand significantly during the forecast period[4].

End-User Segmentation

The end-user segmentation includes hospitals, clinics, home care settings, and others. Each segment has its own growth trajectory based on the healthcare infrastructure and patient preferences in different regions[1][4].

Regional Analysis

Global Market Scope

The doxepin hydrochloride market is analyzed across five major regions: North America, Europe, Asia-Pacific, Middle East and Africa, and South and Central America. Each region has its own market size and forecast estimates from 2021 to 2031[1][4].

Regional Market Trends

• North America: This region is expected to see significant growth due to the high prevalence of mental health disorders and favorable reimbursement policies.
• Asia-Pacific: The APAC region is anticipated to grow rapidly due to the large population and increasing awareness of mental health issues.
• Europe: Europe is also a key market, driven by the high demand for psychiatric medications and the presence of major pharmaceutical companies[1][4].

Financial Trajectory

Market Size and CAGR

The global doxepin hydrochloride market size in 2023 is estimated to be in the millions of US dollars, with a projected compound annual growth rate (CAGR) of XX% from 2024 to 2031. The market is expected to reach a significantly higher value by 2031[1][4].

Revenue Forecast

The revenue forecast indicates steady growth, driven by increasing demand and expanding applications of doxepin hydrochloride. The North American market, for instance, is estimated to increase from a certain million in 2023 to reach a higher figure by 2030[3].

Challenges and Restraints

Side Effects and Adverse Reactions

Common side effects such as insomnia, nausea, dry mouth, and blurry vision, along with adverse effects like mania and suicidal tendencies, are significant restraints on the market's growth. These side effects necessitate careful monitoring and management[1][5].

Economic and Geopolitical Factors

Economic downturns, geopolitical tensions, and higher inventory levels can lead to weak demand and declining prices, as seen in the German and U.S. markets in late 2022. These factors can temporarily impact the financial trajectory of the drug[2].

Key Players and Competitive Landscape

Major Market Players

Companies like Pfizer INC, Ajanta Pharma Ltd, Aurobindo Pharma USA Inc, Viatris Inc, Par Pharmaceutical, Teva API, GlaxoSmithKline, and Roche Diagnostics GmbH are key players in the doxepin hydrochloride market. These companies are focusing on expanding their product portfolios and strengthening their market presence[1][4].

Competitive Strategies

To stay competitive, these companies are investing in research and development, strategic partnerships, and market expansion. They are also focusing on building robust distribution networks to ensure widespread availability of the drug[4].

Future Trends and Opportunities

Increasing Awareness of Mental Health

The growing awareness of mental health issues and the reduction of stigma around seeking treatment are expected to drive the demand for doxepin hydrochloride in the future.

Advancements in Drug Formulations

Advancements in drug formulations, such as improved oral and topical forms, could enhance the efficacy and safety profile of doxepin hydrochloride, attracting more patients and healthcare providers[5].

Emerging Markets

Emerging markets in Asia-Pacific and Latin America offer significant opportunities for growth due to their large populations and increasing healthcare spending[1][4].

Key Takeaways

• The doxepin hydrochloride market is driven by the increasing prevalence of mental health disorders, favorable reimbursement policies, and the growing geriatric population.
• The market is segmented into oral and topical forms, with various applications and end-users.
• Regional analysis shows significant growth potential in North America, Asia-Pacific, and Europe.
• Despite challenges like side effects and economic factors, the market is expected to grow steadily.
• Key players are focusing on expanding their product portfolios and market presence.

FAQs

1. What are the primary drivers of the doxepin hydrochloride market?

The primary drivers include the increasing prevalence of mental health disorders, the growing geriatric population, and favorable reimbursement policies in developed countries.

2. What are the common side effects of doxepin hydrochloride?

Common side effects include insomnia, nausea, dry mouth, and blurry vision, while adverse effects can include mania and suicidal tendencies.

3. Which regions are expected to see significant growth in the doxepin hydrochloride market?

North America, Asia-Pacific, and Europe are expected to see significant growth due to high demand and favorable market conditions.

4. Who are the key players in the doxepin hydrochloride market?

Key players include Pfizer INC, Ajanta Pharma Ltd, Aurobindo Pharma USA Inc, Viatris Inc, Par Pharmaceutical, and others.

5. What are the future trends and opportunities in the doxepin hydrochloride market?

Future trends include increasing awareness of mental health, advancements in drug formulations, and growth opportunities in emerging markets.

Cited Sources:

1. The Insight Partners: Doxepin Hydrochloride Market SWOT Analysis by 2031
2. Chemanalyst: Global Doxepin Hydrochloride Prices to Decline Because of Weak Demand
3. Valuates Reports: Doxepin Hydrochloride for Injection Market
4. Cognitive Market Research: Doxepin Hydrochloride Market Report 2024 (Global Edition)
5. NCBI: Doxepin - StatPearls - National Institutes of Health (NIH)

Last updated: 2024-12-16