ATROPINE - Generic Drug Details

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

Atropine is the generic ingredient in twenty-two branded drugs marketed by MMT, Abbvie, Rafa Labs Ltd, 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, and Wyeth Ayerst, and is included in seventy-one NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for atropine. Two suppliers are listed for this compound.

Summary for ATROPINE

US Patents:	0
Tradenames:	22
Applicants:	57
NDAs:	71
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	416
Patent Applications:	7,185
Drug Prices:	Drug price trends for ATROPINE
What excipients (inactive ingredients) are in ATROPINE?	ATROPINE excipients list
DailyMed Link:	ATROPINE at DailyMed

See drug prices for ATROPINE

Recent Clinical Trials for ATROPINE

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

Sponsor	Phase
Case Western Reserve University	Phase 1
State University of New York	Phase 1
Southern California College of Optometry at Marshall B. Ketchum University	Phase 1

See all ATROPINE clinical trials

Pharmacology for ATROPINE

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

Medical Subject Heading (MeSH) Categories for ATROPINE

Adjuvants, Anesthesia

Anti-Arrhythmia Agents

Bronchodilator Agents

Muscarinic Antagonists

Mydriatics

Parasympatholytics

Anatomical Therapeutic Chemical (ATC) Classes for ATROPINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	ISOPTO ATROPINE	atropine sulfate	SOLUTION/DROPS;OPHTHALMIC	208151-001	Dec 1, 2016	AT2	RX	Yes	Yes
Vangard	LO-TROL	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	088009-001	Mar 25, 1983		DISCN	No	No
Sun Pharm Industries	DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE	atropine sulfate; diphenoxylate hydrochloride	TABLET;ORAL	085506-001	Approved Prior to Jan 1, 1982		DISCN	No	No

ATROPINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Atropine

Overview of the Atropine Market

The atropine market is experiencing significant growth, driven by several key factors. Atropine, a medication with diverse applications in healthcare, is witnessing an upward trend in demand and revenue.

Market Size and Growth Projections

The global atropine market was substantial in 2020 and is expected to continue growing at a rapid pace. By 2033, the market is projected to be worth around USD 318.1 million, growing at a CAGR of 2.50% from 2024 to 2033[3].

Driving Factors

Increasing Ophthalmic Disorders

The rising prevalence of ophthalmic conditions such as myopia, amblyopia, Diabetic Retinopathy, and Macular Degeneration is driving the demand for atropine eye drops. These conditions are more common in the aging population, contributing to the market's expansion[1][3].

Advancements in Drug Formulations

Innovations in atropine delivery systems and concentrations have enhanced treatment efficacy and patient compliance. This includes the development of more effective and convenient formulations, such as atropine eye drops and injections[3][4].

Expanding Geriatric Population

The aging demographic is more susceptible to various health conditions that require atropine treatment. This demographic shift is a significant driver of the atropine market[1][3].

Rising Healthcare Expenditure

Increasing healthcare spending and improved insurance coverage for ophthalmic medications are supporting the growth of the atropine market. Public and private investments in healthcare infrastructure and research are also contributing to this trend[1][4].

Product Type and Application Segments

Product Type

The injection segment of the atropine market is expected to achieve the highest revenue share over the forecast period. Atropine injections allow for immediate administration and rapid therapeutic effects, making them highly effective in emergency and surgical settings[1].

Application Segments

The ophthalmology segment is anticipated to dominate the market in terms of revenue generation. The increasing number of ophthalmic procedures and the rising prevalence of eye-related diseases are key factors driving this segment[1].

Regional Market Analysis

North America

North America was the largest market for atropine in 2020, driven by well-established medical facilities, higher customer awareness, and a growing geriatric population. The region also benefits from significant R&D activities in the healthcare industry[1].

Asia Pacific

The Asia Pacific region is expected to register the fastest CAGR over the forecast period. This growth is attributed to the expanding healthcare sector, increasing private and government investments, and the adoption of advanced technologies such as digital medical records and telemedicine. Countries like India and China are investing heavily in improving their healthcare infrastructure, which is boosting the demand for pharmaceutical products, including atropine[1].

Europe and Middle East

Europe's atropine market is growing due to the rising demand for ophthalmic atropine and the increasing prevalence of myopia. In the Middle East, the market is driven by the expanding pharmaceutical industry and the rising demand for antispasmodic medications[3].

Financial Trajectory

Revenue Growth

The global atropine market is expected to register a rapidly inclining revenue CAGR between 2021 and 2028. This growth is supported by increasing demand in the healthcare sector, particularly in ophthalmology and other medical applications[1].

Key Players and Investments

Major players in the atropine market are expected to gain new growth opportunities due to the expansion of the pharmaceutical industry. Companies are investing heavily in R&D, which is projected to propel the atropine market in the near future. For instance, Santen Pharmaceutical has made significant progress in its medium-long term growth strategy, including approvals for new products and structural reforms to improve profitability[1][2].

Technological Advancements

Technological advancements, such as digital medical records, telemedicine, and robotic healthcare solutions, are contributing to the growth of the atropine market. These advancements enhance the efficiency and accessibility of healthcare services, thereby increasing the demand for pharmaceutical products like atropine[1].

Competitive Landscape

The atropine market is characterized by a competitive landscape with several key players. These companies are focusing on improving profitability through structural reforms, cost optimization, and the development of new products. For example, Santen Pharmaceutical has achieved significant revenue and core operating profit growth through its strategic initiatives, including the approval of new products and the streamlining of operations in the Americas[2].

Challenges and Opportunities

Challenges

Despite the growth prospects, the atropine market faces challenges such as regulatory hurdles, competition from generic drugs, and the need for continuous innovation to maintain market share.

Opportunities

The market presents several opportunities, including the expansion into emerging markets, the development of new formulations, and the increasing adoption of atropine in various medical applications. The growing focus on precision medicine and home care settings also offers potential for market expansion[4].

Key Takeaways

• The global atropine market is expected to grow significantly, driven by increasing ophthalmic disorders, advancements in drug formulations, and an expanding geriatric population.
• The injection segment is anticipated to dominate the market in terms of revenue share.
• The ophthalmology segment is expected to be the leading application segment.
• North America is currently the largest market, while the Asia Pacific region is expected to register the fastest CAGR.
• Technological advancements and increasing healthcare expenditure are key drivers of market growth.
• Major players are investing heavily in R&D and structural reforms to improve profitability.

FAQs

Q: What are the primary drivers of the atropine market?

The primary drivers include increasing ophthalmic disorders, advancements in drug formulations, an expanding geriatric population, and rising healthcare expenditure.

Q: Which segment is expected to dominate the atropine market in terms of revenue share?

The injection segment is expected to achieve the highest revenue share over the forecast period.

Q: Which region is anticipated to register the fastest CAGR in the atropine market?

The Asia Pacific region is expected to register the fastest CAGR due to expanding healthcare infrastructure and increasing investments.

Q: What are the key challenges faced by the atropine market?

Challenges include regulatory hurdles, competition from generic drugs, and the need for continuous innovation.

Q: What opportunities does the atropine market present?

Opportunities include expansion into emerging markets, development of new formulations, and increasing adoption in various medical applications.

Sources

1. Reports and Data: Atropine Market Size, Share, Growth, Trends & Forecast 2028
2. Santen Pharmaceutical: FY2023 Financial Results
3. Marketresearch.biz: Atropine Market Estimated to Reach USD 318.1 Million by 2033
4. Reports and Data: Atropine Market Growth 2022-2028: Increasing Number of Fatalities and Significant Surgical Operations
5. Market Research Intellect: Global Atropine Sulfate Injection Market Size, Trends and Projections