ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for atropine sulfate; diphenoxylate hydrochloride and what is the scope of patent protection?

Atropine sulfate; diphenoxylate hydrochloride is the generic ingredient in ten branded drugs marketed by Scherer Rp, Medpointe Pharm Hlc, Hikma, Alpharma Us Pharms, Gd Searle Llc, Md Pharm, Able, Ani Pharms, Ascot, Bayshore Pharms Llc, Chartwell Rx, Dr Reddys Labs Sa, Fosun Pharma, Heather, Inwood Labs, Kv Pharm, Lannett, Leading, Lederle, Mylan, Parke Davis, Pvt Form, R And S Pharma, Roxane, Specgx Llc, Strides Pharma, Sun Pharm Industries, Upsher Smith Labs, Usl Pharma, Valeant Pharm Intl, Watson Labs, Winder Labs Llc, Vangard, Superpharm, Pfizer, and Halsey, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Twenty suppliers are listed for this compound.

Summary for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

US Patents:	0
Tradenames:	10
Applicants:	36
NDAs:	39
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	5
Clinical Trials:	1
Patent Applications:	122
DailyMed Link:	ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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

Sponsor	Phase
University of California, San Francisco	Phase 2
Puma Biotechnology, Inc.	Phase 2
Napo Pharmaceuticals, Inc.	Phase 2

See all ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE clinical trials

Pharmacology for ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Heather	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086798-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fosun Pharma	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	086173-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Alpharma Us Pharms	LOMANATE	atropine sulfate; diphenoxylate hydrochloride	SOLUTION;ORAL	085746-001	Approved Prior to Jan 1, 1982		DISCN	No	No

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atropine Sulfate and Diphenoxylate Hydrochloride

Current Market Size and Growth Projections

As of 2023, the atropine sulfate market, which includes formulations with diphenoxylate hydrochloride, was valued at over USD 101.36 million. This figure is expected to rise substantially, with projections indicating the market will exceed USD 186.45 million by 2036, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2036[1].

Growth Drivers

Several key factors are driving the expansion of the atropine sulfate and diphenoxylate hydrochloride market:

Increasing Surgical Procedures

The global increase in surgical services is a significant driver. Atropine sulfate is often used as a preoperative drug, and the rising number of surgeries worldwide is boosting its demand[1].

Expanding Medical Applications

Atropine sulfate is used in various medical specialties, including gastrointestinal, ophthalmology, neurology, and as an antidote for organophosphate poisoning and bradycardia. This broad range of applications is sustaining market growth[1].

Advancements in Drug Delivery

Improvements in pharmaceutical formulations and drug delivery systems are enhancing the efficacy and availability of atropine sulfate and diphenoxylate hydrochloride, contributing to market growth. Key players are investing in research and development to improve these aspects[1].

Financial Performance and Projections

Revenue Growth

The market is expected to grow from USD 105.25 million in 2024 to over USD 186.45 million by 2036, with a CAGR of 4.8% during the forecast period. Different reports indicate slightly varying CAGRs, but the overall trend is positive[1].

CAGR Variations

• A CAGR of 4.8% from 2024 to 2036[1].
• A CAGR of 5% from 2024 to 2031[3].
• A CAGR of 2% from 2023 to 2030 for the atropine sulfate injection market specifically[4].

Investment and R&D

Investors are increasingly interested in the atropine sulfate and diphenoxylate hydrochloride market due to its growth potential. Companies are investing in research and development to improve drug formulations and delivery systems, which is expected to further boost market growth[1].

Online Sales and Distribution

The shift towards online sales is also a notable trend, particularly for atropine sulfate injections and diphenoxylate hydrochloride tablets. Online pharmacies are becoming more popular, providing accessibility to a broader consumer base and contributing to market expansion[4].

Regional Market Dynamics

North America and Asia Pacific

North America and the Asia Pacific region are the primary drivers of market growth. North America's advanced healthcare infrastructure and the Asia Pacific's increasing healthcare investments are key factors contributing to this growth[4].

Porter’s Five Forces Analysis

The market analysis includes a Porter’s Five Forces analysis, which examines the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition within the market. This analysis helps in understanding the competitive dynamics and potential barriers to entry[3].

Product Specifics: Diphenoxylate Hydrochloride and Atropine Sulfate

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. The combination is effective due to the antidiarrheal properties of diphenoxylate hydrochloride and the anticholinergic properties of atropine sulfate[3].

Dosage and Administration

The initial adult dosage is typically 2 tablets four times daily, with a maximum total daily dose of 20 mg of diphenoxylate hydrochloride. The dosage may be reduced to meet individual requirements after initial control of diarrhea has been achieved[3].

Bioavailability and Pharmacokinetics

Studies have shown a linear relationship between the dose of diphenoxylate hydrochloride and the peak plasma concentration, the area under the plasma concentration-time curve, and the amount of diphenoxylic acid excreted in the urine. The bioavailability of the tablet compared to the liquid formulation is approximately 90%[3].

Market Competition and Key Players

The market for atropine sulfate and diphenoxylate hydrochloride is competitive, with several key players. For example, ANI Pharmaceuticals has successfully re-commercialized diphenoxylate HCl and atropine sulfate tablets, contributing to the market's growth. The annual U.S. market for these tablets is approximately $56 million[4].

Challenges and Considerations

Safety and Dosage

Atropine sulfate and diphenoxylate hydrochloride are not without risks. Overdosage can result in severe respiratory depression and coma, particularly in children. Therefore, strict adherence to dosage recommendations is crucial[2].

Pregnancy and Fertility

There are limited studies on the use of diphenoxylate hydrochloride and atropine sulfate in pregnant women. The drugs should be used during pregnancy only if the anticipated benefit justifies the potential risk to the fetus[3].

Key Takeaways

• The atropine sulfate and diphenoxylate hydrochloride market is growing significantly due to increased surgical procedures, expanding medical applications, and advancements in drug delivery.
• North America and the Asia Pacific region are key drivers of market growth.
• The market is expected to exceed USD 186.45 million by 2036, growing at a CAGR of 4.8% from 2024 to 2036.
• Investments in healthcare infrastructure and R&D are crucial for market expansion.
• Online sales are emerging as a significant distribution channel.

FAQs

1. What are the primary applications of atropine sulfate and diphenoxylate hydrochloride? Atropine sulfate and diphenoxylate hydrochloride are used in various medical specialties, including anesthesia, ophthalmology, and as an antidote for organophosphate poisoning and bradycardia. They are also effective as adjunctive therapy in the management of diarrhea[1][3].

2. Which regions are driving the growth of the atropine sulfate and diphenoxylate hydrochloride market? North America and the Asia Pacific region are the primary drivers of market growth, due to their advanced healthcare infrastructure and increasing healthcare investments, respectively[4].

3. What is the projected CAGR for the atropine sulfate and diphenoxylate hydrochloride market? The market is expected to grow at a CAGR of 4.8% from 2024 to 2036, although different reports indicate slightly varying CAGRs[1][3].

4. How are advancements in drug delivery impacting the market? Improvements in pharmaceutical formulations and drug delivery systems are enhancing the efficacy and availability of atropine sulfate and diphenoxylate hydrochloride, contributing to market growth[3].

5. What role do online sales play in the atropine sulfate and diphenoxylate hydrochloride market? Online sales are becoming increasingly important, providing accessibility to a broader consumer base and contributing to market expansion, especially in regions with limited access to brick-and-mortar pharmacies[4].

Cited Sources:

1. Research Nester - Atropine Sulfate Market Size[1]
2. DailyMed - Diphenoxylate Hydrochloride and Atropine Sulfate[2]
3. Market Research Intellect - Global Atropine Sulfate Market Size and Projections[3]
4. Cognitive Market Research - Atropine Sulfate Injection Market Report 2024[4]
5. ANI Pharmaceuticals - Launch Of Diphenoxylate HCl And Atropine Sulfate Tablets[4]