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Last Updated: April 11, 2025

Pyridostigmine bromide - Generic Drug Details


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What are the generic sources for pyridostigmine bromide and what is the scope of patent protection?

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

SponsorPhase
University of Vermont Medical CenterPhase 2
Stefan Holubar MD MS FACS, FASCRSPhase 2/Phase 3
Michael Debakey Veterans Affairs Medical CenterEarly Phase 1

See all pyridostigmine bromide clinical trials

Pharmacology for pyridostigmine bromide
Medical Subject Heading (MeSH) Categories for pyridostigmine bromide
Anatomical Therapeutic Chemical (ATC) Classes for pyridostigmine bromide

US Patents and Regulatory Information for pyridostigmine bromide

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Us Army PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET;ORAL 020414-001 Feb 5, 2003 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Alvogen PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 204737-001 Jun 26, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rising PYRIDOSTIGMINE BROMIDE pyridostigmine bromide TABLET, EXTENDED RELEASE;ORAL 205464-001 Aug 15, 2017 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 3 of 3 entries

International Patents for pyridostigmine bromide

CountryPatent NumberTitleEstimated Expiration
European Patent Office 3648747 FORMES POSOLOGIQUES À RÉTENTION GASTRIQUE DESTINÉES À UNE ADMINISTRATION DE MÉDICAMENT PROLONGÉE (GASTRORETENTIVE DOSAGE FORMS FOR SUSTAINED DRUG DELIVERY) ⤷  Try for Free
Japan 2022109907 ピリドスチグミンを含む持続放出組成物 ⤷  Try for Free
Spain 2861153 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 3 of 3 entries

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.