ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for atropine sulfate; difenoxin hydrochloride and what is the scope of freedom to operate?

Atropine sulfate; difenoxin hydrochloride is the generic ingredient in two branded drugs marketed by Sebela Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE at DailyMed

Pharmacology for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

Drug Class	Anticholinergic Antidiarrheal Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

A03BA	Belladonna alkaloids, tertiary amines
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sebela Ireland Ltd	MOTOFEN	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-002	Approved Prior to Jan 1, 1982
Sebela Ireland Ltd	MOTOFEN HALF-STRENGTH	atropine sulfate; difenoxin hydrochloride	TABLET;ORAL	017744-001	Approved Prior to Jan 1, 1982

ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atropine Sulfate and Diphenoxylate Hydrochloride

Introduction

Atropine sulfate and diphenoxylate hydrochloride are components of a medication commonly used to manage diarrhea. Understanding the market dynamics and financial trajectory of these drugs is crucial for pharmaceutical companies, investors, and healthcare professionals.

Market Overview

The market for atropine sulfate and diphenoxylate hydrochloride is part of the broader antidiarrheal and anticholinergic drug markets. Here are some key points to consider:

Atropine Sulfate Market

• The global atropine sulfate injection market is expected to grow at a compound annual growth rate (CAGR) of 2.00% from 2023 to 2030. This growth is driven by the increasing need for atropine in emergency medical situations such as organophosphate poisoning and bradycardia[3].
• North America holds a significant market share, approximately 40%, due to its advanced healthcare infrastructure and high incidence of diseases requiring atropine interventions[3].
• The Asia Pacific region is emerging as the fastest-growing hub, with a projected market share of around 20% by 2030, driven by increasing healthcare investments and a growing population[3].

Diphenoxylate Hydrochloride and Atropine Sulfate Tablets Market

• The U.S. market for diphenoxylate hydrochloride and atropine sulfate tablets had sales of approximately $64 million for the 12 months ending May 2018. This indicates a stable demand for these tablets in managing diarrhea[1].

Financial Trajectory

Revenue and Sales

• The atropine sulfate injection market is anticipated to reach significant revenue by 2030, with North America and the Asia Pacific region being key contributors. The exact figures are projected to be in the billions of USD, though specific numbers are not disclosed in the available sources[3].
• For diphenoxylate hydrochloride and atropine sulfate tablets, the $64 million in U.S. sales for 2018 suggests a steady revenue stream. This figure is likely to remain stable or see moderate growth, given the consistent demand for antidiarrheal medications[1].

Market Drivers

• Advanced healthcare infrastructure and high incidence of diseases requiring atropine interventions in North America are significant drivers for the atropine sulfate market[3].
• Increasing healthcare investments, a growing population, and expanding healthcare infrastructure in the Asia Pacific region are driving the growth of both atropine sulfate and diphenoxylate hydrochloride markets[3].

Market Challenges

• One of the challenges is the strict dosage recommendations and potential adverse reactions associated with these medications, particularly in pediatric patients. This necessitates careful monitoring and adherence to prescribing guidelines[4][5].
• The risk of severe respiratory depression and coma, especially in children under 2 years of age, is a critical concern that affects market dynamics and prescribing practices[5].

Product Information and Usage

Indications and Usage

• Diphenoxylate hydrochloride and atropine sulfate tablets are indicated as adjunctive therapy in the management of diarrhea in patients 13 years of age and older[2][4][5].
• Atropine sulfate injections are used in emergency medical situations such as organophosphate poisoning and bradycardia[3].

Dosage and Administration

• The dosage of diphenoxylate hydrochloride and atropine sulfate tablets can be adjusted after initial control of diarrhea, often maintained with as little as two tablets daily[2][4].
• Atropine sulfate injections are administered based on the specific medical condition being treated, with careful consideration of the patient's response and potential side effects[3].

Bioavailability and Pharmacokinetics

Bioavailability

• The bioavailability of diphenoxylate hydrochloride and atropine sulfate tablets compared to the liquid form is approximately 90%[2][4][5].
• The peak plasma concentration of diphenoxylic acid, the active metabolite of diphenoxylate, is reached about 2 hours after ingestion, with an elimination half-life of 12 to 14 hours[2][4][5].

Metabolism and Excretion

• Diphenoxylate is rapidly metabolized to diphenoxylic acid, which is the major metabolite in the blood. The drug and its metabolites are primarily excreted in the feces and urine[2].

Safety and Adverse Reactions

Contraindications

• Diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients with respiratory and/or CNS depression, anticholinergic and opioid toxicities, dehydration, electrolyte imbalance, and certain GI complications[2][4][5].

Adverse Reactions

• Common adverse reactions include nervous system effects such as dizziness, sedation, and confusion, as well as allergic reactions like anaphylaxis and urticaria[2][4].

Market Trends

Regional Growth

• The Asia Pacific region is expected to be a significant growth hub for both atropine sulfate injections and diphenoxylate hydrochloride tablets, driven by increasing healthcare investments and a growing population[3].

Online Sales

• The trend towards online sales is becoming more prominent, especially in regions with limited access to brick-and-mortar pharmacies. This shift is expected to continue, providing greater accessibility to a broader consumer base[3].

Key Players

Pharmaceutical Companies

• Companies like Pfizer and Hikma Pharmaceuticals are focusing on strategies to strengthen their product portfolios and expand their business in the global market[3].

Conclusion

The market for atropine sulfate and diphenoxylate hydrochloride is characterized by steady demand driven by their critical roles in managing diarrhea and emergency medical conditions. The financial trajectory indicates moderate growth, particularly in regions with advanced healthcare infrastructure and growing populations.

Key Takeaways

• Stable Demand: The market for diphenoxylate hydrochloride and atropine sulfate tablets shows stable demand, with U.S. sales of approximately $64 million in 2018.
• Regional Growth: The Asia Pacific region is expected to be a significant growth hub for both atropine sulfate injections and diphenoxylate hydrochloride tablets.
• Safety Considerations: Strict adherence to dosage recommendations is crucial due to potential adverse reactions, especially in pediatric patients.
• Market Drivers: Advanced healthcare infrastructure and increasing healthcare investments are key drivers for market growth.
• Online Sales: The trend towards online sales is increasing, providing greater accessibility to consumers.

FAQs

Q: What is the primary use of diphenoxylate hydrochloride and atropine sulfate tablets? A: These tablets are used as adjunctive therapy in the management of diarrhea in patients 13 years of age and older[2][4][5].

Q: What is the expected growth rate of the global atropine sulfate injection market? A: The global atropine sulfate injection market is expected to grow at a CAGR of 2.00% from 2023 to 2030[3].

Q: Which regions are driving the growth of the atropine sulfate market? A: North America and the Asia Pacific region are the key drivers, with North America holding a 40% market share and the Asia Pacific region being the fastest-growing hub[3].

Q: What are the potential adverse reactions associated with diphenoxylate hydrochloride and atropine sulfate tablets? A: Potential adverse reactions include nervous system effects, allergic reactions, and atropinism, particularly in pediatric patients[2][4][5].

Q: How is the bioavailability of diphenoxylate hydrochloride and atropine sulfate tablets compared to the liquid form? A: The bioavailability of the tablets is approximately 90% compared to the liquid form[2][4][5].

Sources

1. Upsher-Smith Launches Generic Version of Lomotil - PR Newswire
2. Diphenoxylate Hydrochloride and Atropine Sulfate Tablets - DailyMed
3. Atropine Sulfate Injection Market Report 2024 - Cognitive Market Research
4. Diphenoxylate Hydrochloride and Atropine Sulfate Tablets - Pfizer Labeling
5. Diphenoxylate Hydrochloride and Atropine Sulfate Tablets - DailyMed