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, Endo Operations, Mylan Pharms Inc, 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-four patent family members in thirty-one countries.

Seven suppliers are listed for this compound.

Summary for doxylamine succinate; pyridoxine hydrochloride

International Patents:	64
US Patents:	4
Tradenames:	4
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	7
Clinical Trials:	4
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
First Affiliated Hospital of Heilongjiang Chinese Medicine University	Phase 3
Ningxia Hui Autonomous Region Hospital of TCM	Phase 3
Jixi Maternal and Child Health Hospital	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
Endo Operations	DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE	doxylamine succinate; pyridoxine hydrochloride	TABLET, DELAYED RELEASE;ORAL	208518-001	Dec 6, 2017	AB	RX	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
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
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

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
New Zealand	729042	Plurimodal release formulation of doxylamine and pyridoxine and/or metabolites or salts thereof
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.)
Taiwan	I595874
European Patent Office	2787971	FORMULATION DE DOXYLAMINE ET DE PYRIDOXINE ET/OU DE LEURS MÉTABOLITES OU SELS (FORMULATION OF DOXYLAMINE AND PYRIDOXINE AND/OR METABOLITES OR SALTS THEREOF)
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)
Denmark	3326611

Doxylamine succinate; pyridoxine hydrochloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Doxylamine Succinate and Pyridoxine Hydrochloride

Introduction

Doxylamine succinate and pyridoxine hydrochloride, often combined in a single formulation, are crucial in the treatment of nausea and vomiting of pregnancy (NVP). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this drug combination.

Market Overview

The market for doxylamine succinate and pyridoxine hydrochloride is driven by the increasing need for effective treatments for NVP, a condition affecting a significant number of pregnant women. The combination of these two components has been approved by regulatory bodies such as the FDA, marking a significant milestone in the treatment of this condition[5].

Historical Context

Historically, the combination of doxylamine succinate and pyridoxine hydrochloride was part of the formulation known as Bendectin, which was widely used in the 1970s and early 1980s. However, due to litigation and adverse publicity, Bendectin was withdrawn from the market in 1983. The current formulation, Diclegis (or Xonvea in some regions), was approved in 2013, providing a renewed treatment option for NVP[5].

Current Market Status

Approval and Regulation

The FDA approved Diclegis in 2013 as the first and only FDA-approved treatment for NVP after conservative management has failed. This approval has been a significant factor in the market's growth, as it provides a validated treatment option for a condition with limited therapeutic alternatives[5].

Clinical Efficacy

Studies such as the DESI and DIC-301 trials have demonstrated the clinical efficacy of the doxylamine succinate and pyridoxine hydrochloride combination. These studies showed statistically significant improvements in symptoms of NVP compared to placebo, making the treatment a valuable option for pregnant women[4].

Safety Profile

The safety profile of this combination is generally favorable, with common adverse events including somnolence, dizziness, dry mouth, and fatigue. The combination has been found to be safe and well-tolerated when used in the recommended doses[4].

Market Growth and Forecast

Revenue and Growth Rate

The market for doxylamine succinate and pyridoxine hydrochloride is expected to experience significant growth. While specific revenue figures for this exact combination are not readily available, the broader market context suggests a positive trajectory. For instance, the pyridoxine hydrochloride market, which is closely related, is forecasted to reach USD 731.5 million by 2028, growing at a CAGR of 8.00% from 2019 to 2028[1].

Regional Market Dynamics

The Asia Pacific region is expected to lead the market due to high demand for animal feeds and the presence of major manufacturing countries like China. This regional dominance is a key factor in the overall market growth[1].

Key Players and Strategies

Major Companies

Companies such as Duchesnay, Inc., which developed Diclegis, play a crucial role in the market. Other key players include pharmaceutical companies that manufacture and distribute pyridoxine hydrochloride, such as DSM Tianxin Pharmaceutical, Hegno, and BASF Human Nutrition[1].

Market Strategies

Companies in this market have focused on strategies like new product launches, partnerships, acquisitions, and mergers to retain their customer base and increase market share. The development of new formulations, such as extended-release tablets, has also been a strategic move to improve patient compliance and efficacy[2].

Financial Trajectory

Revenue Projections

The financial trajectory of the market is positive, driven by the increasing demand for effective treatments for NVP and the broader use of pyridoxine hydrochloride in various applications. The forecasted growth rate and revenue projections indicate a robust financial outlook for the coming years[1].

Cost and Pricing

The cost and pricing of the drug combination are influenced by factors such as production costs, regulatory approvals, and market competition. The approval of Diclegis has set a benchmark for pricing, which is expected to be competitive given the limited number of FDA-approved treatments for NVP[5].

Challenges and Opportunities

Challenges

Despite the positive market dynamics, there are challenges associated with the long-term use of pyridoxine hydrochloride, such as potential changes in blood electrolytes, muscle weakness, heart function disorders, and liver damage. These adverse effects can negatively impact market growth if not adequately managed[1].

Opportunities

The lack of other FDA-approved treatments for NVP presents a significant opportunity for the growth of this drug combination. Additionally, the expanding demand for animal feeds and the increasing use of pyridoxine hydrochloride in various industrial applications further enhance the market's potential[1].

Regulatory Environment

FDA Approval and Compliance

The FDA approval of Diclegis has been a critical factor in the market's growth. Regulatory compliance and ongoing postmarketing studies are essential to maintaining the drug's approval status and ensuring its safety and efficacy[5].

Patient Compliance and Adherence

Formulation Innovations

Innovations in drug formulation, such as the development of extended-release tablets, have improved patient compliance by reducing the number of tablets required daily. This has been a strategic move to enhance the treatment's efficacy and patient adherence[2].

Conclusion

The market for doxylamine succinate and pyridoxine hydrochloride is poised for significant growth, driven by the clinical efficacy of the combination, favorable safety profile, and the lack of alternative FDA-approved treatments for NVP. The financial trajectory is positive, with forecasted revenue growth and strategic market moves by key players.

Key Takeaways

• FDA Approval: Diclegis is the only FDA-approved treatment for NVP after conservative management has failed.
• Clinical Efficacy: The combination has shown statistically significant improvements in NVP symptoms.
• Safety Profile: Generally safe and well-tolerated, with common adverse events such as somnolence and dizziness.
• Market Growth: Forecasted to grow at a CAGR of 8.00% from 2019 to 2028.
• Regional Dynamics: Asia Pacific leads the market due to high demand and major manufacturing countries.
• Challenges and Opportunities: Potential adverse effects and limited treatment options present both challenges and opportunities.

FAQs

Q: What is the primary indication for the combination of doxylamine succinate and pyridoxine hydrochloride?

A: The primary indication is for the treatment of nausea and vomiting of pregnancy (NVP) after conservative management has failed.

Q: Which region is expected to lead the market for this drug combination?

A: The Asia Pacific region is expected to lead the market due to high demand and the presence of major manufacturing countries.

Q: What are the common adverse events associated with this drug combination?

A: Common adverse events include somnolence, dizziness, dry mouth, and fatigue.

Q: Has the FDA approved any other treatments for NVP besides Diclegis?

A: No, Diclegis is the only FDA-approved treatment for NVP after conservative management has failed.

Q: What are the strategic moves by key players in this market?

A: Key players have focused on new product launches, partnerships, acquisitions, and mergers, as well as the development of new formulations to improve patient compliance.

Sources

1. Reports and Data, "Pyridoxine Hydrochloride Market | Demand & Growth, 2020-2028"
2. FDA, "209661Orig1s000 - accessdata.fda.gov"
3. Cognitive Market Research, "Doxylamine Market Report 2024 (Global Edition)"
4. NHS Midlands and Lancashire, "doxylamine-and-pyridoxine-new-medicine-assessment.pdf"
5. FDA, "021876Orig1s000 - accessdata.fda.gov"