ATROPINE SULFATE - Generic Drug Details

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

Atropine sulfate is the generic ingredient in seventeen branded drugs marketed by Us Army, Amneal, Apotex, Bausch And Lomb Inc, Mankind Pharma, Rising, Somerset, Somerset Theraps Llc, Alcon Labs Inc, Accord Hlthcare, Am Regent, Hospira, Intl Medication Sys, Medefil Inc, Fresenius Kabi Usa, Hikma, Sebela Ireland Ltd, Scherer Rp, Medpointe Pharm Hlc, 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, Halsey, Norvium Bioscience, Abbvie, and Wyeth Ayerst, and is included in sixty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for atropine sulfate. Twenty-three suppliers are listed for this compound.

Summary for ATROPINE SULFATE

US Patents:	0
Tradenames:	17
Applicants:	55
NDAs:	66
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	138
Clinical Trials:	50
Patent Applications:	6,444
What excipients (inactive ingredients) are in ATROPINE SULFATE?	ATROPINE SULFATE excipients list
DailyMed Link:	ATROPINE SULFATE at DailyMed

Recent Clinical Trials for ATROPINE SULFATE

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

Sponsor	Phase
Zhaoke (Hong Kong) Ophthalmology Pharmaceutical Limited	Phase 1
Shandong University of Traditional Chinese Medicine	N/A
Shanghai Eye Disease Prevention and Treatment Center	N/A

See all ATROPINE SULFATE clinical trials

Pharmacology for ATROPINE SULFATE

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

Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE SULFATE

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

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ATROPINE SULFATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	216120-001	May 26, 2022	AP	RX	No	No
Norvium Bioscience	ENLON-PLUS	atropine sulfate; edrophonium chloride	INJECTABLE;INJECTION	019678-001	Nov 6, 1991		DISCN	Yes	No
Vangard	LO-TROL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	088009-001	Mar 25, 1983		DISCN	No	No
Halsey	LOW-QUEL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085211-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Accord Hlthcare	ATROPINE SULFATE	atropine sulfate	SOLUTION;INTRAVENOUS	214652-002	Sep 29, 2020	AP	RX	Yes	Yes
Bausch And Lomb Inc	ATROPINE SULFATE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	213581-001	Mar 15, 2022		RX	Yes	Yes

ATROPINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atropine Sulfate

Market Overview

Atropine sulfate is a versatile medication with a wide range of medical applications, including anesthesia, ophthalmology, and as an antidote for various poisonings. The market for atropine sulfate is experiencing significant growth, driven by several key factors.

Current Market Size

As of 2023, the atropine sulfate market size was valued at over USD 101.36 million[1][3].

• This figure is expected to rise substantially, with projections indicating the market will exceed USD 186.45 million by 2036, growing at a CAGR of 4.8% from 2024 to 2036[1].

Growth Drivers

Several factors are driving the expansion of the atropine sulfate market:

Increasing Surgical Procedures

The global increase in surgical services is a major driver. Atropine sulfate is often used as a preoperative drug, and the rising number of surgeries worldwide is boosting its demand[1][3].

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][3].

Advancements in Drug Delivery

Improvements in pharmaceutical formulations and drug delivery systems are enhancing the efficacy and availability of atropine sulfate, further driving its market expansion[3].

Healthcare Infrastructure Investments

Growing investments in healthcare infrastructure and rising awareness among healthcare professionals about the therapeutic uses of atropine sulfate are also contributing to market growth[3][4].

Regional Analysis

The atropine sulfate market is geographically diverse, with different regions exhibiting varying growth patterns:

North America

North America commands a significant share of the atropine sulfate injection market, holding around 40% of the global market. This dominance is attributed to the region's advanced healthcare infrastructure, high incidence of diseases requiring atropine interventions, and robust research and development activities[4].

Asia Pacific

The Asia Pacific region is emerging as the fastest-growing hub, projected to hold a substantial 20% market share. This growth is fueled by increasing healthcare investments, rising awareness about atropine applications, and an increasing prevalence of conditions necessitating its use[4].

Market Segmentation

The atropine sulfate market is segmented based on various factors:

Type

The market is segmented by the type of atropine sulfate product, such as injections and other formulations. The demand for 1 mg/ml atropine sulfate injections remains particularly high[4].

Application

Atropine sulfate is used in various medical applications, including anesthesia, ophthalmology, and as an antidote for poisonings. Each application segment contributes to the overall market growth[3].

Competitive Landscape

The competitive landscape of the atropine sulfate market is characterized by:

Key Players

Several key players are investing in the market, driven by the growing demand and potential for profitability. These players are focusing on improving drug formulations, expanding their market presence, and enhancing their product portfolios[1][3].

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].

Financial Performance and Projections

The financial trajectory of the atropine sulfate market is promising:

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[1].

CAGR Variations

Different reports indicate slightly varying CAGRs:

• 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 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][3].

Online Sales and Distribution

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

Key Takeaways

• The atropine sulfate 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? Atropine sulfate is used in various medical specialties, including anesthesia, ophthalmology, and as an antidote for organophosphate poisoning and bradycardia[1][3].

2. Which regions are driving the growth of the atropine sulfate 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 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, contributing to market growth[3].

5. What role do online sales play in the atropine sulfate 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. Santen Pharmaceutical - FY2023 Financial Results[2]
3. Market Research Intellect - Global Atropine Sulfate Market Size and Projections[3]
4. Cognitive Market Research - Atropine Sulfate Injection Market Report 2024[4]