Doxylamine succinate; pyridoxine hydrochloride - Generic Drug Details

What are the generic drug sources for doxylamine succinate; pyridoxine hydrochloride and what is the scope of freedom to operate?

Doxylamine succinate; pyridoxine hydrochloride is the generic ingredient in four branded drugs marketed by Duchesnay, Actavis Labs Fl Inc, Bionpharma, Mylan Pharms Inc, Ph Health, and Sanofi Aventis Us, and is included in eight NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Doxylamine succinate; pyridoxine hydrochloride has sixty-five patent family members in thirty-two countries.

Seven suppliers are listed for this compound.

Summary for doxylamine succinate; pyridoxine hydrochloride

International Patents:	65
US Patents:	4
Tradenames:	4
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxylamine succinate; pyridoxine hydrochloride
DailyMed Link:	doxylamine succinate; pyridoxine hydrochloride at DailyMed

Recent Clinical Trials for doxylamine succinate; pyridoxine hydrochloride

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

Sponsor	Phase
Nawaz Sharif Medical College	NA
University of Gujrat	NA
Luoyang Hospital of TCM	Phase 3

See all doxylamine succinate; pyridoxine hydrochloride clinical trials

Pharmacology for doxylamine succinate; pyridoxine hydrochloride

Ingredient-type	Analogs/Derivatives Vitamin B 6
Drug Class	Antihistamine Vitamin B6 Analog
Mechanism of Action	Histamine Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for doxylamine succinate; pyridoxine hydrochloride

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

Paragraph IV (Patent) Challenges for DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BONJESTA	Extended-release Tablets	doxylamine succinate; pyridoxine hydrochloride	20 mg/20 mg	209661	1	2018-08-28
DICLEGIS	Delayed-release Tablets	doxylamine succinate; pyridoxine hydrochloride	10 mg/10 mg	021876	1	2013-08-01

US Patents and Regulatory Information for doxylamine succinate; pyridoxine hydrochloride

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
Actavis Labs Fl Inc	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	205811-001	Aug 19, 2016	AB	RX	No	No
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y
Bionpharma	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	217000-001	Aug 4, 2023	AB	RX	No	No
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes
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
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y

Expired US Patents for doxylamine succinate; pyridoxine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013

International Patents for doxylamine succinate; pyridoxine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Japan	2016053092	ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Japan	2017525731	ドキシラミン並びにピリドキシン及び／またはそれらの代謝産物もしくは塩の多峰性放出製剤
Portugal	3185856
Canada	2848798	FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS METABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Japan	2016053092	ドキシラミンおよびピリドキシン、ならびに／またはその代謝物もしくは塩の製剤 (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
Argentina	101728	FORMULACIÓN DE LIBERACIÓN PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS
Taiwan	201334780	Formulation of doxylamine and pyridoxine and/or metabolites or salts thereof

Supplementary Protection Certificates for doxylamine succinate; pyridoxine hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3185856	CR 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	122024000003	Germany		PRODUCT NAME: KOMBINATION AUS DOXYLAMIN, ODER EINES PHARMAZEUTISCH AKZEPTABLEN SALZES DAVON, UND PYRIDOXIN, ODER EINES PHARMZEUTISCH AKZEPTABLEN SALZES DAVON; NAT. REGISTRATION NO/DATE: 7006779.00.00 20230717; FIRST REGISTRATION: NIEDERLANDE RVG 128835 20230216
3185856	CA 2024 00001	Denmark		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; NAT. REG. NO/DATE: 66650 20230704; FIRST REG. NO/DATE: NL RVG 128835 20230216
3185856	LUC00356	Luxembourg		PRODUCT NAME: COMBINATION OF DOXYLAMINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND PYRIDOXINE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; AUTHORISATION NUMBER AND DATE: 2024030081 20240220
3185856	2024C/535	Belgium		PRODUCT NAME: COMBINATIE VAN DOXYLAMINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN PYRIDOXINE, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE662396 20240321

Market Dynamics and Financial Trajectory for Doxylamine Succinate and Pyridoxine Hydrochloride

Last updated: July 28, 2025

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Introduction

Doxylamine succinate and pyridoxine hydrochloride are pharmacologically distinct compounds often combined in formulations addressing pregnancy-related nausea and sleep disorders. Their market dynamics are influenced by evolving clinical guidelines, regulatory landscapes, competitive pressures, and demographic trends. Understanding these forces is essential for stakeholders aiming to navigate the complex pharmaceutical landscape effectively.

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Pharmacological Profile and Indications

Doxylamine Succinate:
An antihistamine with sedative properties, primarily used as an over-the-counter sleep aid and in combination therapies for nausea. Its efficacy in managing pregnancy-related nausea led to formulations like Diclegis (doxylamine + pyridoxine), approved by the FDA in 2013 [1].

Pyridoxine Hydrochloride:
Vitamin B6 derivative, crucial for amino acid metabolism and neurotransmitter synthesis. Its anti-nausea effect, especially in pregnancy, has been well-documented, leading to widespread use in combination therapies.

The pairing of these agents leverages their complementary mechanisms, positioning them as the go-to option for nausea during pregnancy, which has historically created a stable therapeutic niche.

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Market Dynamics

1. Regulatory Landscape Evolution

The landmark FDA approval of Diclegis in 2013 marked a pivotal moment, transforming the combination into a prescription product after decades of OTC use [1]. Since then, regulatory considerations have become increasingly stringent, with agencies emphasizing safety profiles and efficacy evidence.

Post-approval, some markets have seen shifts towards generic formulations, which pressure branded product prices. Regulatory agencies increasingly demand robust post-market surveillance, affecting manufacturer strategies and timelines.

2. Clinical Guidelines and Physician Preferences

Official guidelines endorse pyridoxine-based therapies as first-line management, reinforcing sustained demand [2]. However, emerging alternatives such as symptom-specific antiemetics and non-pharmacologic interventions influence prescribing patterns.

Physicians' preference for evidence-based, safe, and cost-effective options enhances the market for doxylamine-pyridoxine combinations, especially in regions with conservative prescribing practices.

3. Consumer Trends and Demographics

Rising awareness among pregnant women about safe treatment options fuels demand for OTC and prescription versions. The global increase in maternal health awareness and prenatal care coverage amplifies this effect, particularly in North America, Europe, and parts of Asia.

However, concerns related to side effects of sedative antihistamines have prompted cautious prescribing, potentially constraining market expansion.

4. Competitive Landscape

The core competition involves:

• Branded formulations like Diclegis.
• Generics and biosimilars entering markets, reducing prices.
• Alternative antiemetics, such as metoclopramide or ondansetron, which have gained popularity despite safety debates [3].

This competitive pressure impacts profit margins and influences R&D investments in related formulations.

5. Patent and Intellectual Property Trends

While Diclegis held patent exclusivity until patent expiration or challenges, patent cliffs have opened doors for generic manufacturers, increasing market penetration and price competition [4].

Innovations in formulation and delivery mechanisms could serve as future patentable assets, incentivizing R&D.

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Financial Trajectory and Market Forecasts

1. Current Market Size and Revenue

Estimates suggest the global market for pregnancy-related antiemetic treatments, including doxylamine-pyridoxine combinations, exceeded USD 1.2 billion in 2022, propelled by increased maternal healthcare expenditure and awareness [5].

Diclegis and generic products constitute a significant share of revenue streams, with branded sales maintaining premium pricing, especially in mature markets.

2. Growth Drivers

• Rising maternal health awareness: Enhanced prenatal screening and counseling.
• Regulatory approvals: New markets opening due to expanded indications.
• Increased prevalence of nausea and vomiting in pregnancy (NVP): Affecting approximately 70-80% of pregnant women [6].

Compound annual growth rate (CAGR) projections indicate a modest 3-5% growth through 2028, driven primarily by emerging markets and expanded indications.

3. Market Challenges and Risks

• Safety concerns: Reports questioning the safety of sedative antihistamines and antiemetics may impact demand.
• Generic competition: Eroding profit margins.
• Pricing pressures: Cost-containment policies by health authorities threaten revenue streams.
• Alternative therapies: Non-pharmacologic approaches or newer pharmacologic agents could diminish market share.

4. Investment and R&D Outlook

Pharmaceutical companies are exploring novel delivery mechanisms, such as sustained-release formulations, to extend patent life and improve efficacy [7]. Additionally, combination products with minimal sedative effects are under development to address safety concerns.

Interest in developing natural or plant-based alternatives could reshape the competitive landscape, though regulatory pathways remain complex.

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Market Penetration in Key Regions

Region	Market Size (USD Billion, 2022)	Growth Rate (2023-2028)	Key Drivers	Challenges
North America	0.6	4%	High awareness, strong healthcare infrastructure	Safety concerns, patent expirations
Europe	0.3	3.5%	Maternal health policies, aging population	Stringent regulations, alternative therapies
Asia-Pacific	0.2	6%	Growing maternal healthcare access, increasing awareness	Regulatory hurdles, pricing pressures
Latin America	0.1	5%	Expanding healthcare coverage	Limited awareness, infrastructure challenges

Note: Figures are approximate and forecast-based.

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Strategic Outlook

For stakeholders, maintaining a competitive edge entails:

• Investing in formulation innovations to address safety and efficacy concerns.
• Monitoring regulatory developments for early market entry opportunities.
• Expanding into emerging markets with tailored marketing strategies.
• Building robust pharmacovigilance programs to reinforce safety profiles.
• Differentiating through patient-centric delivery systems and packaging.

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Key Takeaways

• The doxylamine succinate and pyridoxine hydrochloride combination sustains a stable and moderately growing market, driven by pregnancy management needs.

• Regulatory approvals, particularly the FDA’s 2013 clearance of Diclegis, catalyzed market expansion but also intensified competition from generics post-patent expiry.

• The global rise in maternal health awareness and prenatal care uptake underpin ongoing demand, especially in emerging markets.

• Pricing pressures, safety concerns, and competition from alternative therapies pose significant market risks; innovation in formulation and delivery mechanisms are critical for future growth.

• Stakeholders should focus on regulatory intelligence, R&D investments, and market expansion strategies to capitalize on unmet needs and demographic trends.

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FAQs

1. What is the primary therapeutic use of doxylamine succinate and pyridoxine hydrochloride?
   They are primarily used to treat nausea and vomiting during pregnancy, with safety profiles supported by extensive clinical data, making them a standard first-line therapy.

2. How has the patent landscape affected the market for these drugs?
   Patent expiration has led to increased availability of generic formulations, intensifying price competition but also opening opportunities for market expansion through cost-effective alternatives.

3. What are the main safety concerns associated with these medications?
   Sedative effects of doxylamine may cause side effects like drowsiness, and safety concerns have prompted ongoing evaluations of their safety profiles, especially in certain populations.

4. Are there emerging competitors in this therapeutic niche?
   Yes, newer antiemetics with different mechanisms of action and non-pharmacologic interventions are emerging, potentially challenging the traditional combination’s market share.

5. What future innovations could influence this market?
   Development of sustained-release formulations, combination products with improved safety profiles, and alternative delivery systems are potential game-changers.

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References

[1] FDA. "Diclegis (doxylamine succinate and pyridoxine hydrochloride) Tablets." 2013.
[2] ACOG Practice Bulletin No. 207: Nausea and Vomiting of Pregnancy. Obstetrics & Gynecology, 2019.
[3] Koren G, et al. "Safety of antiemetics in pregnancy." Drug Safety, 2014.
[4] Generic Patent Database, 2022.
[5] MarketWatch. "Pregnancy Anti-Emetics Market Size, Trends & Forecasts." 2022.
[6] Einarson A, et al. "Global prevalence of nausea and vomiting during pregnancy." BJOG, 2018.
[7] Pharma Innovators Quarterly. "Novel formulations in antiemetics." 2022.