PYRIDOSTIGMINE BROMIDE - Generic Drug Details

What are the generic sources for pyridostigmine bromide and what is the scope of freedom to operate?

Pyridostigmine bromide is the generic ingredient in three branded drugs marketed by Bausch, Sandoz, Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Impax Labs, MLV, Solvay, Us Army, and Zydus Pharms, and is included in twenty-one NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pyridostigmine bromide has nineteen patent family members in seven countries.

There are eleven drug master file entries for pyridostigmine bromide. Twenty-three suppliers are listed for this compound.

Summary for PYRIDOSTIGMINE BROMIDE

International Patents:	19
US Patents:	8
Tradenames:	3
Applicants:	15
NDAs:	21
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	23
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	21
Patent Applications:	1,943
What excipients (inactive ingredients) are in PYRIDOSTIGMINE BROMIDE?	PYRIDOSTIGMINE BROMIDE excipients list
DailyMed Link:	PYRIDOSTIGMINE BROMIDE at DailyMed

Recent Clinical Trials for PYRIDOSTIGMINE BROMIDE

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

Sponsor	Phase
University of Vermont Medical Center	Phase 2
Stefan Holubar MD MS FACS, FASCRS	Phase 2/Phase 3
Baylor College of Medicine	Early Phase 1

See all PYRIDOSTIGMINE BROMIDE clinical trials

Pharmacology for PYRIDOSTIGMINE BROMIDE

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Medical Subject Heading (MeSH) Categories for PYRIDOSTIGMINE BROMIDE

Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PYRIDOSTIGMINE BROMIDE

N07AA	Anticholinesterases
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for PYRIDOSTIGMINE BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Msn	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	SYRUP;ORAL	216512-001	Sep 21, 2023	AA	RX	No	No
Amneal	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	217604-001	Oct 4, 2024		DISCN	No	No			Y
Sandoz	REGONOL	pyridostigmine bromide	INJECTABLE;INJECTION	017398-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
Impax Labs Inc	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	203184-001	Sep 15, 2015	AB	RX	No	No
Amneal	PYRIDOSTIGMINE BROMIDE	pyridostigmine bromide	TABLET, EXTENDED RELEASE;ORAL	217604-001	Oct 4, 2024		DISCN	No	No			Y

International Patents for PYRIDOSTIGMINE BROMIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	3609472
European Patent Office	4056172	EXTENDED RELEASE COMPOSITIONS COMPRISING PYRIDOSTIGMINE
European Patent Office	3609472
Japan	2021522310
Canada	3061382	EXTENDED RELEASE COMPOSITIONS COMPRISING PYRIDOSTIGMINE

PYRIDOSTIGMINE BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pyridostigmine Bromide

Introduction

Pyridostigmine bromide, an orally active, reversible acetylcholinesterase inhibitor, has been gaining significant attention in the pharmaceutical market due to its diverse therapeutic applications. This article delves into the market dynamics and financial trajectory of pyridostigmine bromide, highlighting key trends, drivers, and forecasts.

Market Size and Growth Projections

The global pyridostigmine bromide API market has been experiencing rapid and substantial growth. As of 2023, the market was valued at a significant figure, and it is anticipated to reach even higher values by 2030, indicating a robust growth trajectory[1][4].

Segmentation and Regional Analysis

The market is segmented based on type (purity ≥98% and purity <98%), application (tablets and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). Regional market sizes are crucial for understanding the competitive landscape and market ranks of key players[1][4].

Production and Consumption Trends

Global production and consumption of pyridostigmine bromide API are forecasted to increase significantly from 2019 to 2030. The report provides detailed estimates and forecasts by region, including North America, Europe, China, and Japan. For instance, North America and Europe are expected to show steady growth rates in both production and consumption[1].

Price Analysis

The market price analysis by region from 2019 to 2024 and the forecasted prices from 2025 to 2030 are critical for understanding the economic viability of the drug. The prices vary by type and region, reflecting market dynamics and demand-supply balances[1].

Application and Therapeutic Uses

Pyridostigmine bromide is used in various therapeutic applications, most notably in the treatment of neurogenic orthostatic hypotension (OH), myasthenia gravis, and other neuromuscular disorders. Its efficacy in improving standing blood pressure, especially diastolic blood pressure, without worsening supine hypertension, has been well-documented[2].

Drivers of Market Growth

Several factors drive the growth of the pyridostigmine bromide API market:

• Increasing Prevalence of Neuromuscular Disorders: The rising incidence of conditions such as myasthenia gravis and neurogenic OH is driving the demand for effective treatments.
• Advancements in Pharmaceutical Technology: Improvements in manufacturing processes and quality control have enhanced the purity and efficacy of pyridostigmine bromide API.
• Expanding Healthcare Infrastructure: Growing healthcare infrastructure in emerging markets is increasing access to advanced treatments, including those involving pyridostigmine bromide[4].

Challenges and Restraints

Despite the positive outlook, the market faces several challenges:

• Regulatory Hurdles: Strict regulatory requirements and the need for clinical trials can slow market entry and expansion.
• Side Effects and Adverse Events: While generally well-tolerated, pyridostigmine bromide can cause side effects, which may impact patient compliance and market growth[5].

Competitive Landscape

The competitive landscape of the pyridostigmine bromide API market is characterized by several key players. The report provides profiles of these competitors, their market ranks, and technological trends. Understanding the competitive landscape is crucial for developing business and growth strategies[1].

Technological Trends and New Product Developments

The market is witnessing technological advancements, including improvements in API purity and new formulations. These developments are expected to enhance the therapeutic efficacy and safety profile of pyridostigmine bromide, further driving market growth[1].

Pharmacokinetics and Patient Compliance

Pyridostigmine bromide has a short half-life, requiring multiple daily doses to maintain therapeutic levels. This can impact patient compliance. However, dose-escalation strategies and careful monitoring can minimize side effects and improve treatment outcomes[5].

Economic and Social Impact

The economic impact of the growing pyridostigmine bromide API market is significant, with projections indicating substantial revenue growth. Socially, the availability of effective treatments for neuromuscular disorders improves the quality of life for patients and their families.

Key Statistics and Forecasts

• Market Value: The global pyridostigmine bromide API market is projected to reach significant values by 2030, with a compound annual growth rate (CAGR) reflecting robust growth[1][4].
• Regional Growth: North America and Europe are expected to maintain their positions as major markets, while the Asia-Pacific region is anticipated to show rapid growth due to expanding healthcare infrastructure[1].
• Application Segments: Tablets remain the primary application segment, but other applications are also gaining traction[4].

Expert Insights

"Pyridostigmine bromide has shown significant promise in treating neurogenic orthostatic hypotension without worsening supine hypertension. Its efficacy in improving standing blood pressure is a critical therapeutic benefit," notes Dr. Wolfgang Singer, a leading researcher in the field[2].

Key Takeaways

• The global pyridostigmine bromide API market is experiencing rapid growth driven by increasing demand for treatments of neuromuscular disorders.
• Regional markets, particularly in North America and Europe, are significant, with the Asia-Pacific region showing promising growth.
• Technological advancements and new product developments are enhancing the market.
• Patient compliance and side effect management are crucial for maximizing therapeutic benefits.

FAQs

Q: What is the primary therapeutic use of pyridostigmine bromide? A: Pyridostigmine bromide is primarily used in the treatment of neurogenic orthostatic hypotension, myasthenia gravis, and other neuromuscular disorders.

Q: What are the key drivers of the pyridostigmine bromide API market growth? A: The market growth is driven by the increasing prevalence of neuromuscular disorders, advancements in pharmaceutical technology, and expanding healthcare infrastructure.

Q: How does pyridostigmine bromide affect blood pressure in patients with neurogenic OH? A: Pyridostigmine bromide significantly improves standing diastolic blood pressure without worsening supine hypertension[2].

Q: What are the common side effects of pyridostigmine bromide? A: While generally well-tolerated, pyridostigmine bromide can cause mild to moderate side effects, which are often self-limiting[5].

Q: What is the forecasted market value of the pyridostigmine bromide API market by 2030? A: The market is anticipated to reach significant values by 2030, reflecting a robust growth trajectory[1][4].

Cited Sources:

1. Global Pyridostigmine Bromide API Market Research Report 2024 - QY Research
2. Pyridostigmine Treatment Trial in Neurogenic Orthostatic Hypotension - JAMA Network
3. Global Pyridostigmine Bromide API Market Growth 2023-2029 - Market Research Reports
4. Pyridostigmine Bromide API Market Size, Scope And Forecast Report - Market Research Intellect
5. Randomized double-blind placebo-controlled crossover trial with pyridostigmine - Brain Communications