DOXYLAMINE SUCCINATE - Generic Drug Details

What are the generic sources for doxylamine succinate and what is the scope of patent protection?

Doxylamine succinate is the generic ingredient in eight branded drugs marketed by Pfizer, Sanofi Aventis Us, Par Pharm, Copley Pharm, LNK, Perrigo, Quantum Pharmics, Chattem, Duchesnay, Actavis Labs Fl Inc, Bionpharma, Endo Operations, and Mylan Pharms Inc, and is included in sixteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for doxylamine succinate. Thirty-one suppliers are listed for this compound.

Summary for DOXYLAMINE SUCCINATE

US Patents:	4
Tradenames:	8
Applicants:	13
NDAs:	16
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	6
Patent Applications:	2,231
What excipients (inactive ingredients) are in DOXYLAMINE SUCCINATE?	DOXYLAMINE SUCCINATE excipients list
DailyMed Link:	DOXYLAMINE SUCCINATE at DailyMed

Recent Clinical Trials for DOXYLAMINE SUCCINATE

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

Sponsor	Phase
Heilongjiang provincial hospital	Phase 3
Suihua Maternal and Child Health Hospital	Phase 3
Affiliated Hospital of Jiamusi Medical University	Phase 3

See all DOXYLAMINE SUCCINATE clinical trials

Pharmacology for DOXYLAMINE SUCCINATE

Drug Class	Antihistamine
Mechanism of Action	Histamine Receptor Antagonists

Medical Subject Heading (MeSH) Categories for DOXYLAMINE SUCCINATE

Antiemetics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for DOXYLAMINE SUCCINATE

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for DOXYLAMINE SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	BENDECTIN	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	010598-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Mylan Pharms Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	207825-001	Jul 6, 2020	AB	RX	No	No
Par Pharm	DOXY-SLEEP-AID	doxylamine succinate	TABLET;ORAL	070156-001	Jul 2, 1987		DISCN	No	No
Endo Operations	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518-001	Dec 6, 2017	AB	RX	No	No
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y

DOXYLAMINE SUCCINATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Doxylamine Succinate

Introduction

Doxylamine succinate, a widely used antihistamine and sedative, is a key component in various over-the-counter (OTC) medications, including Nyquil. The market for doxylamine succinate is experiencing significant growth, driven by several factors. Here, we delve into the market dynamics, financial trajectory, and key aspects influencing this market.

Market Size and Growth

The global doxylamine succinate market has witnessed substantial growth in recent years. As of 2023, the market size was valued at several billion USD and is projected to expand further by 2031, exhibiting a notable compound annual growth rate (CAGR)[1][3].

Segmentation

The market is segmented based on several criteria:

• Type: Solid and liquor forms are the primary types of doxylamine succinate available in the market[1][3].
• Application: The drug is used as an antihistamine, anticholinergic, sedative, and in other applications[1][3].
• Geography: The market is analyzed across regions such as North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1][3].

Drivers

Several factors are driving the growth of the doxylamine succinate market:

• Increasing Demand for OTC Medications: The rising demand for over-the-counter medications, particularly for cold and flu relief, is a significant driver. Nyquil, which contains doxylamine succinate, is a popular choice for such conditions[2].
• Expanding Healthcare Needs: Growing healthcare needs, especially in emerging economies, are contributing to the increased demand for antihistamines and sedatives[3].
• Advancements in Pharmaceutical Technology: Improvements in pharmaceutical manufacturing and formulation are enhancing the efficacy and safety of doxylamine succinate products[3].

Restraints

Despite the growth, there are several restraints affecting the market:

• Regulatory Challenges: Strict regulatory frameworks and the need for compliance can slow down market growth. Manufacturers must adhere to stringent guidelines to ensure the safety and efficacy of their products[1][3].
• Misuse and Addiction: The misuse of doxylamine succinate, particularly in Nyquil, leading to addiction and health complications, is a significant concern. This can impact market perception and regulatory scrutiny[2].

Opportunities

The market presents several opportunities for growth:

• Emerging Markets: Expanding into emerging economies where healthcare infrastructure is developing offers significant growth potential[3].
• Innovative Formulations: Developing new formulations and delivery methods can attract more consumers and expand market share[3].

Challenges

The market faces several challenges:

• Competition: The presence of numerous competitors, including both established and emerging players, makes the market highly competitive[1][3].
• Economic Factors: Economic fluctuations and changes in consumer spending patterns can impact market growth[3].

Competitive Landscape

The competitive landscape of the doxylamine succinate market is characterized by:

• Key Players: Companies such as Teva, CHATTEM, DUCHESNAY, LNK INTERNATIONAL INC, PERRIGO, Viatris (MYLAN), and others are prominent players in the market. These companies are focusing on expanding their product portfolios and geographical presence[1][3].
• Market Positioning: The market positioning of these companies is influenced by their product/service portfolios, financial performance, strategic initiatives, and regional presence[1].

Financial Trajectory

The financial trajectory of the doxylamine succinate market is positive, with projected significant revenue growth from 2023 to 2031. Here are some key financial insights:

• Revenue Growth: The market is expected to grow at a notable CAGR, driven by increasing demand and expanding applications[1][3].
• Regional Performance: North America and Europe are currently leading the market, but Asia-Pacific is expected to show significant growth due to increasing healthcare needs and economic development[1][3].

Regional Analysis

The market performance varies across different regions:

• North America: This region is a major market for doxylamine succinate, driven by high demand for OTC medications and a well-established healthcare system[1][3].
• Europe: Europe also represents a significant market, with a strong focus on pharmaceutical innovation and regulatory compliance[1][3].
• Asia-Pacific: This region is expected to experience rapid growth due to increasing healthcare expenditure and a large population base[1][3].

SWOT Analysis

A SWOT analysis provides a comprehensive view of the market:

• Strengths: Established market presence, growing demand for OTC medications, and advancements in pharmaceutical technology.
• Weaknesses: Regulatory challenges, misuse and addiction issues, and high competition.
• Opportunities: Expanding into emerging markets, innovative formulations, and increasing healthcare needs.
• Threats: Economic fluctuations, changes in consumer behavior, and stringent regulatory environments[1][3].

Market Outlook

The market outlook for doxylamine succinate is promising, with several factors shaping its future:

• Growth Catalysts: Increasing demand, technological advancements, and expanding healthcare needs.
• Constraints: Regulatory challenges, competition, and economic factors.
• Opportunities and Challenges: Emerging markets, innovative formulations, and the need to address misuse and addiction issues[1][3].

Porter's 5 Forces Framework

This framework helps in understanding the competitive structure of the market:

• Threat of New Entrants: Moderate due to regulatory barriers and the need for significant investment.
• Bargaining Power of Suppliers: Low to moderate as suppliers are numerous and the market is competitive.
• Bargaining Power of Buyers: Moderate to high as buyers have several options and are price-sensitive.
• Threat of Substitute Products: Moderate as there are alternative antihistamines and sedatives available.
• Competitive Rivalry Among Existing Competitors: High due to the presence of many established and emerging players[1][3].

Key Takeaways

• The doxylamine succinate market is experiencing significant growth driven by increasing demand for OTC medications.
• The market is segmented by type, application, and geography.
• Key drivers include growing healthcare needs and advancements in pharmaceutical technology.
• Regulatory challenges and misuse issues are significant restraints.
• Emerging markets and innovative formulations present opportunities for growth.

FAQs

1. What are the primary applications of doxylamine succinate?

Doxylamine succinate is primarily used as an antihistamine, anticholinergic, and sedative. It is also used in other applications such as in the treatment of cold and flu symptoms[1][3].

2. Which regions are leading the doxylamine succinate market?

North America and Europe are currently the leading regions, but Asia-Pacific is expected to show significant growth in the future[1][3].

3. What are the major challenges facing the doxylamine succinate market?

The market faces challenges such as regulatory scrutiny, competition, economic fluctuations, and the issue of misuse and addiction[1][3].

4. How is the competitive landscape of the doxylamine succinate market?

The market is highly competitive with several established and emerging players. Companies like Teva, CHATTEM, and DUCHESNAY are prominent in the market[1][3].

5. What is the projected growth rate of the doxylamine succinate market?

The market is expected to grow at a notable CAGR from 2023 to 2031, driven by increasing demand and expanding applications[1][3].

Citations

1. Market Research Intellect, "Doxylamine Succinate Market Size, Scope And Forecast Report," October 2024.
2. White Light Behavioral Health, "Nyquil Addiction: Symptoms, Causes, Effects & Treatment," August 20, 2024.
3. Cognitive Market Research, "Doxylamine Market Report 2024 (Global Edition)," October 19, 2022.