METHSCOPOLAMINE BROMIDE - Generic Drug Details

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

Methscopolamine bromide is the generic ingredient in three branded drugs marketed by Bayshore Pharms Llc, Breckenridge Pharm, Chartwell Rx, Ne Rx Pharma, Pvt Form, and Fougera Pharms, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for methscopolamine bromide. Three suppliers are listed for this compound.

Summary for METHSCOPOLAMINE BROMIDE

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Patent Applications:	1,612
What excipients (inactive ingredients) are in METHSCOPOLAMINE BROMIDE?	METHSCOPOLAMINE BROMIDE excipients list
DailyMed Link:	METHSCOPOLAMINE BROMIDE at DailyMed

Pharmacology for METHSCOPOLAMINE BROMIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for METHSCOPOLAMINE BROMIDE

A04AD	Other antiemetics
A04A	ANTIEMETICS AND ANTINAUSEANTS
A04	ANTIEMETICS AND ANTINAUSEANTS
A	Alimentary tract and metabolism

N05CM	Other hypnotics and sedatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for METHSCOPOLAMINE BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Breckenridge Pharm	METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	040642-002	Dec 6, 2011	AA	RX	No	No
Chartwell Rx	METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	040624-001	Dec 28, 2006		DISCN	No	No
Bayshore Pharms Llc	METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	200602-001	Sep 24, 2012	AA	RX	No	No
Ne Rx Pharma	METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	216786-001	Feb 1, 2024	AA	RX	No	No
Pvt Form	METHSCOPOLAMINE BROMIDE	methscopolamine bromide	TABLET;ORAL	080970-001	Approved Prior to Jan 1, 1982		DISCN	No	No

METHSCOPOLAMINE BROMIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Methscopolamine Bromide

Introduction

Methscopolamine bromide is a small molecule drug that belongs to the class of anticholinergic medications. It is primarily used to target muscarinic acetylcholine receptors (mAChRs) and is approved for the treatment of various digestive system disorders, motion sickness, nausea, and peptic ulcers. Here, we delve into the market dynamics and financial trajectory of this drug.

Historical Approval and Global Recognition

Methscopolamine bromide was first approved for use in the United States and China in April 1953, marking its early entry into the pharmaceutical market. This long history of approval and use underscores its established position and global recognition[1].

Therapeutic Applications

The drug is indicated for several therapeutic areas, including:

• Digestive System Disorders: Methscopolamine bromide is effective in managing peptic ulcers and other stomach-related disorders by inhibiting gastric acid secretion[2].
• Motion Sickness and Nausea: It is used to treat motion sickness and nausea, leveraging its anticholinergic properties to modulate acetylcholine activity[1].

Market Size and Growth

While specific market size data for methscopolamine bromide is not readily available, it is part of the broader anticholinergic drug market. The hyoscine market, which includes other anticholinergic agents like scopolamine, provides some context. The hyoscine market is estimated to reach $77.4 million by 2027, growing at a CAGR of 4.7% from 2022 to 2027[5].

Distribution Channels

The distribution of methscopolamine bromide, similar to other anticholinergic drugs, can be segmented into offline and online channels. Offline channels, such as hospital pharmacies, dominate the market due to the drug's frequent use in medical settings. However, online channels are expected to grow faster, with a CAGR of 5.4% over the forecast period, driven by the advent of online drug shipping facilitators and discounts[5].

Formulation and Delivery Systems

To enhance the bioavailability and efficacy of methscopolamine bromide, researchers have developed innovative delivery systems. For instance, floating gastroretentive tablets have been formulated to increase the drug's residence time in the stomach, thereby improving absorption and therapeutic effects. These formulations have shown promising results in clinical trials, with the best formulation exhibiting a high cumulative drug release and optimal floating lag time[2].

Financial Trajectory

The financial trajectory of methscopolamine bromide is influenced by several factors:

• Demand and Supply: The demand for anticholinergic drugs, including methscopolamine bromide, is driven by the prevalence of digestive system disorders and other indications. Supply chain investments by pharmaceutical companies are crucial to meet this demand[4].
• Market Competition: The market for anticholinergic drugs is competitive, with several key players such as Alchem International Ltd., Alkaloids Corporation, and GlaxoSmithKline Plc. These companies engage in product launches, mergers and acquisitions, and geographical expansions to maintain market share[5].
• Regulatory Environment: The regulatory environment plays a significant role in the financial trajectory of the drug. Approvals and compliance with regulatory standards are essential for maintaining market presence and expanding into new regions[1].

Future Outlook

The future outlook for methscopolamine bromide is promising due to several factors:

• Increasing Prevalence of Digestive Disorders: The rising prevalence of digestive system disorders and other related diseases is expected to drive the demand for effective treatments like methscopolamine bromide.
• Innovative Delivery Systems: The development of advanced delivery systems, such as floating gastroretentive tablets, is expected to enhance the drug's efficacy and patient compliance, contributing to its financial growth.
• Global Market Expansion: The drug's established global recognition and ongoing efforts to expand into new markets are likely to contribute to its financial trajectory.

Key Takeaways

• Established Market Presence: Methscopolamine bromide has a long history of approval and use, establishing it as a reliable medication.
• Therapeutic Applications: The drug is effective in treating digestive system disorders, motion sickness, and nausea.
• Innovative Delivery Systems: Advanced delivery systems are being developed to enhance the drug's bioavailability and therapeutic effects.
• Competitive Market: The market is competitive, with several key players engaging in various strategies to maintain market share.
• Future Growth: The drug's future outlook is promising due to increasing demand for effective treatments and innovative delivery systems.

FAQs

Q1: What is methscopolamine bromide used for? Methscopolamine bromide is used for the treatment of digestive system disorders, motion sickness, nausea, and peptic ulcers.

Q2: How does methscopolamine bromide work? It works by targeting muscarinic acetylcholine receptors (mAChRs) and modulating the activity of acetylcholine, a neurotransmitter involved in various bodily functions.

Q3: What are the innovative delivery systems for methscopolamine bromide? Floating gastroretentive tablets have been developed to increase the drug's residence time in the stomach, enhancing its absorption and therapeutic effects.

Q4: What is the market size and growth potential for methscopolamine bromide? While specific data is not available, the broader hyoscine market, which includes other anticholinergic agents, is estimated to reach $77.4 million by 2027, growing at a CAGR of 4.7%.

Q5: Who are the key players in the market for methscopolamine bromide? Key players include Alchem International Ltd., Alkaloids Corporation, GlaxoSmithKline Plc, and others, which engage in product launches, mergers and acquisitions, and geographical expansions.

Sources

1. Deep Scientific Insights on methscopolamine bromide's R&D progress - Synapse Patsnap
2. Development and Optimization of Methscopolamine Bromide - Thieme Connect
3. Methscopolamine Bromide Market Size, Share - Prof Research
4. Scaling Up the Impact of Obesity Drugs - Morgan Stanley
5. Hyoscine Market - Forecast(2024 - 2030) - IndustryARC