BENZTROPINE MESYLATE - Generic Drug Details

What are the generic sources for benztropine mesylate and what is the scope of freedom to operate?

Benztropine mesylate is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, Hikma Farmaceutica, Luitpold, Navinta Llc, Epic Pharma Llc, Aiping Pharm Inc, Chartwell Rx, Endo Operations, Invagen Pharms, Lannett Co Inc, Leading, Nuvo Pharm, Oxford Pharms, Pliva, Quantum Pharmics, Usl Pharma, and Merck, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for benztropine mesylate. Twenty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for BENZTROPINE MESYLATE

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	29
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	124
Clinical Trials:	1
Patent Applications:	2,103
Drug Prices:	Drug price trends for BENZTROPINE MESYLATE
Drug Sales Revenues:	Drug sales revenues for BENZTROPINE MESYLATE
What excipients (inactive ingredients) are in BENZTROPINE MESYLATE?	BENZTROPINE MESYLATE excipients list
DailyMed Link:	BENZTROPINE MESYLATE at DailyMed

See drug prices for BENZTROPINE MESYLATE

See drug sales revenues for BENZTROPINE MESYLATE

Recent Clinical Trials for BENZTROPINE MESYLATE

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Boehringer Ingelheim	Phase 2

See all BENZTROPINE MESYLATE clinical trials

Generic filers with tentative approvals for BENZTROPINE MESYLATE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BENZTROPINE MESYLATE

Drug Class	Anticholinergic Antihistamine
Mechanism of Action	Cholinergic Antagonists Histamine Receptor Antagonists

Medical Subject Heading (MeSH) Categories for BENZTROPINE MESYLATE

Antiparkinson Agents

Dopamine Uptake Inhibitors

Muscarinic Antagonists

Parasympatholytics

US Patents and Regulatory Information for BENZTROPINE MESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040715-003	Aug 27, 2007	AA	RX	No	No
Endo Operations	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	040715-002	Aug 27, 2007	AA	RX	No	No
Luitpold	BENZTROPINE MESYLATE	benztropine mesylate	INJECTABLE;INJECTION	091152-001	Mar 29, 2010		DISCN	No	No
Invagen Pharms	BENZTROPINE MESYLATE	benztropine mesylate	TABLET;ORAL	090294-003	Mar 29, 2010		DISCN	No	No

BENZTROPINE MESYLATE Market Analysis and Financial Projection Experimental

Benztropine Mesylate Market Dynamics and Financial Trajectory

Market Introduction

Benztropine mesylate is a synthetic anticholinergic medication used to treat symptoms of Parkinson's disease and drug-induced extrapyramidal symptoms. It works by blocking muscarinic receptors, reducing central cholinergic effects and alleviating symptoms such as muscle stiffness, sweating, and excessive saliva production[1][2][5].

Market Drivers

The benztropine mesylate market is driven by several key factors:

Aging Population

The increasing aging population is a significant driver, as older individuals are more prone to Parkinson's disease and other conditions that require anticholinergic treatment[1][3].

Government Funding for Research

Government funding for research in neurodegenerative diseases, including Parkinson's, has boosted the development and use of benztropine mesylate[1].

Technological Advancements

Advancements in drug manufacturing, such as the use of 3D printing, AI, and ML, are expected to enhance the production of more effective and safer anticholinergic medications, including benztropine mesylate[3].

Market Restraints

Despite the drivers, there are several restraints affecting the market:

Availability of Alternative Treatments

The presence of alternative treatments for Parkinson's disease and extrapyramidal symptoms can reduce the demand for benztropine mesylate[1].

Stringent Regulations

Strict regulatory requirements and the need for rigorous clinical trials can slow down the market growth and increase the costs associated with bringing new formulations to market[1].

Market Segmentation

The benztropine mesylate market is segmented based on several criteria:

Route of Administration

The market is segmented into oral, intramuscular (IM), and intravenous (IV) routes of administration. Each route has specific advantages depending on the indication and patient population[2][5].

Application

The market is segmented based on applications such as parkinsonism and extrapyramidal symptoms. Benztropine mesylate is particularly valuable in addressing drug-induced extrapyramidal symptoms and preventing dystonic reactions[1][2].

Regional Framework

The market is analyzed across various regions, including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America.

North America

North America holds a significant share of the global benztropine mesylate market, driven by the high prevalence of Parkinson's disease and other chronic conditions in the region[1][3].

Europe

Europe is the second-largest market, with key players ensuring high availability and penetration of anticholinergic drugs, including benztropine mesylate[3].

Asia-Pacific

The APAC region is expected to grow substantially due to the rising aging population and increasing awareness of chronic diseases, leading to higher demand for anticholinergic medications[3].

Market Size and Forecast

The benztropine mesylate market is expected to witness high growth during the forecast period from 2023 to 2031.

• Market Size in 2023: The market size in 2023 is estimated to be US$ XX Million.
• Market Size by 2031: The market is projected to reach US$ XX Million by 2031.
• Global CAGR (2023 - 2031): The market is expected to grow at a CAGR of XX% during this period[1][4].

Key Players

Several key players are active in the benztropine mesylate market, including:

• Akorn
• Zydus Pharmaceuticals
• ANI Pharmaceuticals
• PLIVA
• Fresenius Kabi
• Hikma Pharmaceuticals
• Cipla
• Navinta
• Aspen Pharmacare

These companies are focusing on organic and inorganic growth strategies such as new product launches, approvals, acquisitions, and partnerships to expand their business and customer base[1].

Financial Trajectory

The financial trajectory of the benztropine mesylate market is influenced by several factors:

Revenue Growth

The market is expected to see significant revenue growth driven by the increasing demand for anticholinergic medications, particularly in regions with aging populations and high prevalence of chronic diseases[1][3].

Investment in Research and Development

Companies are investing heavily in research and development to improve the efficacy and safety of benztropine mesylate, which is expected to drive market growth and attract more investments[1][3].

Competitive Landscape

The competitive landscape is dynamic, with key players engaging in various strategies to maintain and increase their market share. This includes expanding product portfolios, entering new markets, and forming strategic partnerships[1].

PEST Analysis

A detailed PEST analysis highlights the impact of political, economic, social, and technological factors on the benztropine mesylate market:

• Political Factors: Regulatory policies and government funding for research play a crucial role in shaping the market.
• Economic Factors: Economic stability and healthcare expenditure in various regions influence the market growth.
• Social Factors: The aging population and increasing awareness of chronic diseases are significant social factors driving the market.
• Technological Factors: Advances in drug manufacturing and pharmaceutical technologies are enhancing the production and efficacy of benztropine mesylate[1].

Key Takeaways

• The benztropine mesylate market is driven by the aging population and government funding for research.
• The market is segmented by route of administration and application, with oral, IM, and IV routes being prominent.
• North America and Europe are key regions, with APAC expected to grow significantly.
• Key players are focusing on organic and inorganic growth strategies.
• The market is expected to grow at a significant CAGR from 2023 to 2031.

FAQs

What is benztropine mesylate used for?

Benztropine mesylate is used to treat symptoms of Parkinson's disease and drug-induced extrapyramidal symptoms by blocking muscarinic receptors in the central nervous system[1][2].

What are the common routes of administration for benztropine mesylate?

Benztropine mesylate can be administered orally, intramuscularly (IM), and intravenously (IV), each with specific indications and advantages[2][5].

Which regions are key markets for benztropine mesylate?

North America, Europe, and the Asia-Pacific region are significant markets for benztropine mesylate, driven by the prevalence of chronic diseases and aging populations[1][3].

What are the major restraints on the benztropine mesylate market?

The availability of alternative treatments and stringent regulatory requirements are major restraints on the market growth[1].

Who are the key players in the benztropine mesylate market?

Key players include Akorn, Zydus Pharmaceuticals, ANI Pharmaceuticals, PLIVA, Fresenius Kabi, Hikma Pharmaceuticals, Cipla, Navinta, and Aspen Pharmacare[1].

Sources

1. The Insight Partners - Benztropine Mesylate Market SWOT Analysis by 2031
2. NCBI - Benztropine - StatPearls
3. Fortune Business Insights - Anticholinergic Drug Market Size, Share, Growth, Forecast, 2032
4. Market Research Intellect - Benztropine Mesylate Market Size And Projection
5. FDA - Cogentin (benztropine mesylate) injection label