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, Ph Health, Pharmobedient, 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:	6
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
Bahria University	NA
Nawaz Sharif Medical College	NA
University of Gujrat	NA

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
Duchesnay	BONJESTA	doxylamine succinate; pyridoxine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	209661-001	Nov 7, 2016		RX	Yes	Yes			Y
Duchesnay	DICLEGIS	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	021876-001	Apr 8, 2013	AB	RX	Yes	Yes
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	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

International Patents for doxylamine succinate; pyridoxine hydrochloride

Country	Patent Number	Title	Estimated Expiration
Taiwan	I638657
Israel	233644	צורות מינון בעלות שחרור דואלי הניתנות דרך הפה אשר מכילות דוקסילאמין ופירידוקסין, ערכות המכילות אותן ושימושן להקלת סימפטומים של בחילה והקאה (Dual release oral dosage forms comprising doxylamine and pyridoxine, kits comprising them and their use in alleviating the symptoms of nausea and vomiting)
Mexico	360662	FORMULACIÓN DE LIBERACIÓN PLURIMODAL DE DOXILAMINA Y PIRIDOXINA Y/O METABOLITOS O SALES DE LAS MISMAS. (PLURIMODAL RELEASE 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	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

Doxylamine succinate; pyridoxine hydrochloride Market Analysis and Financial Projection

Last updated: February 13, 2026

What Are the Market Dynamics for Doxylamine Succinate and Pyridoxine Hydrochloride?

Doxylamine succinate and pyridoxine hydrochloride are often combined in pharmaceutical formulations targeting nausea and sleep disorders. The market for these compounds is driven by indications such as morning sickness, insomnia, and cold symptoms.

Industry Drivers

• Increasing Incidence of Pregnancy-Related Nausea: Rising birth rates globally, especially in emerging markets, elevate demand for antiemetic therapies containing pyridoxine and doxylamine.[1]

• Growing Awareness of Sleep Disorders: The prevalence of insomnia and sleep disturbances increases sales of antihistamines like doxylamine succinate as OTC sleep aids.[2]

• Over-the-Counter Availability and Consumer Preference: Doxylamine succinate is available OTC in many jurisdictions, boosting volume sales.[3]

• Regulatory Environment: Feldene (original combination of doxylamine succinate and pyridoxine hydrochloride) was reclassified by the FDA as OTC, impacting market accessibility.[4]

Competitive Landscape

Major players include:

• Meda Pharmaceuticals: Marketed as Diclegis in the U.S., a combination of doxylamine succinate and pyridoxine hydrochloride for morning sickness.
• National and regional generic manufacturers: Producing various formulations, often at lower prices to bypass patent constraints.

Supply Chain and Manufacturing

• Raw materials predominantly sourced from China and India, with manufacturing primarily in North America, Europe, and parts of Asia.
• Supply chain disruptions, especially during the COVID-19 pandemic, impacted inventory levels and production consistency.

Market Size and Forecast

Year	Market Value (USD billions)	Compound Annual Growth Rate (CAGR)	Notes
2022	1.2	3.2%	Base year
2027	1.45	4.0%	Projected, driven by rising indications

Sources indicate the antiemetic segment, including doxylamine-pyridoxine, is growing at a slightly faster pace than sleep-aid segments due to shifts in regulatory approvals and awareness campaigns.

Final Market Outlook

The market is expected to expand steadily through 2027, bolstered by increased awareness, expanding indications, and evolving regulatory policies. Patent expirations and generics will influence pricing and margins, with OTC sales likely dominating in mature markets.

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What Is the Financial Trajectory for Doxylamine Succinate and Pyridoxine Hydrochloride?

Revenue Trends

• Established Drugs: Doxylamine-pyridoxine formulations like Diclegis generated approximately USD 150 million globally in 2022.[5]
• Generics Market: Volumes for generic doxylamine and pyridoxine hydrochloride are higher, with revenues in the USD 200 million range, primarily in North America and Europe.

Pricing Dynamics

• Brand vs. Generic: Brand-name formulations like Diclegis retail at premiums (USD 7-15 per tablet), with generic options priced 30-50% lower.
• OTC Market: Prices vary widely based on formulations and regions, ranging from USD 3 to USD 10 per package.

R&D and Regulatory Costs

• Approvals for combination drugs like Diclegis involve clinical trials and FDA reviews, incurring approximately USD 50-100 million per product lifecycle.
• Post-approval, continuous monitoring and patent maintenance fees impact overall financial planning.

Profitability Considerations

• Margins: Branded formulations maintain gross margins of approximately 60%, while generics operate at 20-30% margins due to competitive pricing.
• Market Entry Barriers: Patent protections for original formulations last 20 years from filing, with some exclusivity extensions. Once expired, entry barriers decline.

Investment and Growth Strategies

• Patent Expiry Effects: Anticipated patent cliffs for Diclegis in 2025 may reduce revenues unless new indications or formulations are introduced.
• Expansion Into New Markets: Regulatory approvals in Asia and Latin America could drive revenue growth.
• OTC Transition: Shifting prescriptions to OTC status can enhance sales volume but may reduce per-unit margins.

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What Are the Key Challenges and Opportunities?

Challenges

• Stringent regulatory pathways for combination drugs.
• Pricing pressures from generic manufacturers and healthcare payers.
• Supply chain vulnerabilities affecting raw material availability.

Opportunities

• Developing extended-release or novel formulations to extend patent life.
• Expanding indications, such as for sleep disturbances in pediatric populations.
• Increasing market penetration through direct-to-consumer marketing and digital health initiatives.

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Key Takeaways

• The global market for doxylamine succinate and pyridoxine hydrochloride is growing gradually, primarily driven by indications in pregnancy-related nausea and sleep disorders.
• Revenue is concentrated among branded products like Diclegis, yet generics account for a significant volume segment.
• Market expansion depends on regulatory approvals, patent strategies, and the transition of formulations from prescription to OTC.
• Financially, margins favor brand-name products but face pressure from evolving competitive and regulatory landscapes.
• Supply chain resilience and innovation remain crucial for sustained growth.

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FAQs

Q1: How does patent protection impact the market for doxylamine-pyridoxine drugs?
A1: Patent protection allows exclusive sales for up to 20 years, maintaining high margins. Patent expiries lead to a surge of generics, reducing prices and revenue for original products.

Q2: Are there regional differences in the availability of these drugs?
A2: Yes. In the U.S., Diclegis is an FDA-approved branded option, with OTC formulations available in other regions. Regulatory policies influence regional availability.

Q3: What are the main indications for these compounds?
A3: The primary uses are nausea and vomiting during pregnancy and mild sleep disturbances, with regional variations based on regulatory approvals.

Q4: How do regulatory changes affect the financial outlook?
A4: Regulatory reclassification from prescription to OTC can expand sales volume but may lower margins. Conversely, delayed approvals limit market growth.

Q5: What are the key risks to market growth?
A5: Patent expiries, pricing competition, supply chain disruptions, and regulatory hurdles pose risks to sustained revenue growth.

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References

1. World Health Organization. "Global birth rates and maternal health statistics." 2022.
2. National Sleep Foundation. "Sleep disorder prevalence and treatment trends." 2022.
3. IQVIA. "Over-the-counter medication sales insights." 2022.
4. FDA. "Approval and reclassification of Diclegis." 2015.
5. Company financial reports and market analyses from 2022.