Bethanechol chloride - Generic Drug Details

What are the generic sources for bethanechol chloride and what is the scope of patent protection?

Bethanechol chloride is the generic ingredient in four branded drugs marketed by Odyssey Pharms, Able, Actavis Elizabeth, Amneal Pharm, Ascot, Chartwell Rx, Heritage Pharma, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lannett Co Inc, Sandoz, Sun Pharm Inds Inc, Upsher Smith Labs, Watson Labs, Wockhardt, and Glenwood, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for bethanechol chloride. Six suppliers are listed for this compound.

Summary for bethanechol chloride

US Patents:	0
Tradenames:	4
Applicants:	17
NDAs:	53
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	1
Patent Applications:	2,139
What excipients (inactive ingredients) are in bethanechol chloride?	bethanechol chloride excipients list
DailyMed Link:	bethanechol chloride at DailyMed

Recent Clinical Trials for bethanechol chloride

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

Sponsor	Phase
Rajavithi Hospital	Phase 4

See all bethanechol chloride clinical trials

Pharmacology for bethanechol chloride

Drug Class	Cholinergic Muscarinic Agonist
Mechanism of Action	Cholinergic Muscarinic Agonists

Medical Subject Heading (MeSH) Categories for bethanechol chloride

Muscarinic Agonists

Parasympathomimetics

Anatomical Therapeutic Chemical (ATC) Classes for bethanechol chloride

N07AB	Choline esters
N07A	PARASYMPATHOMIMETICS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for bethanechol chloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal Pharm	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040855-001	Nov 21, 2007	AA	RX	No	Yes
Watson Labs	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	084402-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Odyssey Pharms	URECHOLINE	bethanechol chloride	TABLET;ORAL	006536-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Impax Labs	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040721-003	Nov 1, 2006		DISCN	No	No
Heritage Pharma	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	091256-002	May 4, 2010		DISCN	No	No
Chartwell Rx	DUVOID	bethanechol chloride	TABLET;ORAL	085882-003	Approved Prior to Jan 1, 1982	AA	RX	No	No
Wockhardt	BETHANECHOL CHLORIDE	bethanechol chloride	TABLET;ORAL	040533-001	Sep 29, 2003		DISCN	No	No

Bethanechol chloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Bethanechol Chloride

Introduction

Bethanechol chloride, a synthetic ester and muscarinic agonist, is used to treat various urinary retention conditions, including postoperative, postpartum, and neurogenic atony of the bladder. This article delves into the market dynamics and financial trajectory of bethanechol chloride, providing insights into its market performance, competitive landscape, and future prospects.

Market Size and Growth

The global bethanechol chloride market has shown steady growth in recent years. As of 2022, the market value was estimated to be in the millions of USD, with forecasts indicating continued revenue growth at the global, regional, and country levels[4].

Industry Trends

The demand for bethanechol chloride is driven by the increasing incidence of urinary retention issues, particularly in postoperative and postpartum patients. The drug's effectiveness in stimulating the parasympathetic nervous system and enhancing bladder contraction has made it a preferred treatment option in these scenarios[2].

Competitive Landscape

The market for bethanechol chloride is characterized by the presence of both brand-name and generic versions. The brand-name version, often marketed under the name Duvoid, competes with various generic formulations. The entry of authorized generics during the 180-day exclusivity period has been shown to lower retail and wholesale prices, making the drug more accessible to a wider patient population[3].

Pricing Dynamics

The pricing of bethanechol chloride varies based on the dosage and form of administration. For instance, the cost of bethanechol chloride tablets ranges from approximately $0.71 to $3.95 per tablet, depending on the dosage and brand[2].

Impact of Authorized Generics

Authorized generics have a significant impact on the pricing and revenue dynamics of bethanechol chloride. During the 180-day exclusivity period, the presence of authorized generics can reduce retail generic prices by 4-8% and wholesale prices by 7-14% compared to prices without authorized generic competition. This competition also reduces the revenues of the first-filer generic manufacturer by 40-52% on average[3].

Financial Performance

The financial performance of bethanechol chloride is influenced by several factors, including market demand, competition from generics, and pricing strategies.

Revenue Projections

The global bethanechol chloride market is expected to continue its revenue growth trajectory, driven by increasing demand and the expanding patient population. Market reports forecast revenue growth at various levels, indicating a positive financial outlook for the drug[1][4].

Cost and Pricing Strategies

The cost-effectiveness of bethanechol chloride is a key factor in its market success. The drug's longer-lasting effects compared to acetylcholine, due to its resistance to cholinesterase degradation, make it a valuable treatment option. However, the pricing strategies must balance between profitability and affordability to maintain market share[2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of bethanechol chloride. The approval and regulation of generic versions, including authorized generics, are critical in shaping the competitive landscape and pricing strategies.

Impact on Generic Manufacturers

The presence of authorized generics can affect the incentives of generic manufacturers to challenge patents, particularly for drugs with low sales. However, the overall impact on patent challenges has been found to be minimal, with generic companies continuing to pursue challenges despite the potential for reduced revenues[3].

Side Effects and Safety Considerations

While bethanechol chloride is effective in treating urinary retention, it comes with several side effects that can impact its market acceptance. Common side effects include diarrhea, appetite loss, vomiting, and drooling. In cases of overdose, more severe side effects can occur, necessitating the use of antidotes like atropine[5].

Clinical Use and Indications

Bethanechol chloride is indicated for the treatment of acute postoperative and postpartum urinary retention, as well as neurogenic atony of the bladder with retention. Its mechanism of action involves stimulating muscarinic cholinergic nerve receptors, which enhances the contraction of the detrusor muscle in the bladder[2].

Future Prospects

The future prospects for bethanechol chloride look promising, driven by increasing demand and advancements in healthcare. Here are a few key points:

Expanding Patient Population

The growing incidence of urinary retention issues due to various medical conditions and surgeries is expected to drive the demand for bethanechol chloride.

Technological Advancements

Advancements in drug delivery systems and formulations could enhance the efficacy and safety profile of bethanechol chloride, further solidifying its market position.

Competitive Strategies

Pharmaceutical companies may adopt various competitive strategies, including pricing adjustments and marketing campaigns, to maintain or gain market share in the face of increasing competition from generics.

Key Takeaways

• Market Growth: The global bethanechol chloride market is expected to continue growing, driven by increasing demand and expanding patient populations.
• Competitive Landscape: The market is characterized by the presence of both brand-name and generic versions, with authorized generics playing a significant role in pricing dynamics.
• Financial Performance: Revenue growth is projected, influenced by market demand, competition, and pricing strategies.
• Regulatory Environment: The approval and regulation of generic versions impact the competitive landscape and pricing strategies.
• Side Effects and Safety: Common side effects include diarrhea, appetite loss, and vomiting, with more severe effects in cases of overdose.

FAQs

What is bethanechol chloride used for?

Bethanechol chloride is used to treat postoperative and postpartum nonobstructive functional urinary retention and neurogenic atony of the bladder with retention[2].

How does bethanechol chloride work?

Bethanechol chloride works by stimulating muscarinic cholinergic nerve receptors, which enhances the contraction of the detrusor muscle in the bladder[2].

What are the common side effects of bethanechol chloride?

Common side effects include diarrhea, appetite loss, vomiting, and drooling. More severe side effects can occur in cases of overdose[5].

How does the presence of authorized generics affect the market for bethanechol chloride?

The presence of authorized generics reduces retail and wholesale prices and significantly impacts the revenues of the first-filer generic manufacturer[3].

What is the financial outlook for the bethanechol chloride market?

The market is expected to continue its revenue growth trajectory, driven by increasing demand and the expanding patient population[1][4].

Sources

1. Cognitivemarketresearch.com: Global Bethanechol Chloride CAS 590 63 6 Market Report 2024.
2. DrugBank: Bethanechol: Uses, Interactions, Mechanism of Action.
3. FTC.gov: Authorized Generic Drugs: Short-Term Effects and Long-Term Impact.
4. Maiaresearch.com: Global Bethanechol Chloride Industry Market Competitive Analysis.
5. Marvistavet.com: BETHANECHOL CHLORIDE.