DICYCLOMINE HYDROCHLORIDE - Generic Drug Details

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

Dicyclomine hydrochloride is the generic ingredient in four branded drugs marketed by Allergan, Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Abbvie, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Somerset Theraps Llc, Aptalis Pharma Us, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in forty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dicyclomine hydrochloride. Fifty-five suppliers are listed for this compound.

Summary for DICYCLOMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	29
NDAs:	42
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	1,516
What excipients (inactive ingredients) are in DICYCLOMINE HYDROCHLORIDE?	DICYCLOMINE HYDROCHLORIDE excipients list
DailyMed Link:	DICYCLOMINE HYDROCHLORIDE at DailyMed

Pharmacology for DICYCLOMINE HYDROCHLORIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for DICYCLOMINE HYDROCHLORIDE

Muscarinic Antagonists

Parasympatholytics

US Patents and Regulatory Information for DICYCLOMINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Regent	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	208353-001	Feb 17, 2017	AP	RX	No	No
Abbvie	BENTYL PRESERVATIVE FREE	dicyclomine hydrochloride	INJECTABLE;INJECTION	008370-002	Oct 15, 1984		DISCN	Yes	No
Corepharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	216639-001	Mar 24, 2023	AB	RX	No	No
Praxgen Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	212058-001	Apr 26, 2019		DISCN	No	No
Abbvie	BENTYL	dicyclomine hydrochloride	INJECTABLE;INJECTION	008370-001	Oct 15, 1984		DISCN	Yes	No
Twi Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	216782-001	Jun 1, 2023	AB	RX	No	No

DICYCLOMINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dicyclomine Hydrochloride

Market Overview

The global market for dicyclomine hydrochloride, an anticholinergic and antispasmodic medication, is experiencing significant growth driven by several key factors. Dicyclomine HCl is primarily used to treat symptoms of irritable bowel syndrome (IBS), such as abdominal pain, cramping, and bloating, by relaxing the smooth muscles in the gut[1][4][5].

Market Size and Forecast

The dicyclomine market was valued at USD 1.5 billion in 2024 and is projected to reach USD 2.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period from 2024 to 2031. This growth is attributed to the increasing prevalence of gastrointestinal diseases and disorders, rising stress levels, and unhealthy eating habits[4].

Key Drivers

Increasing Prevalence of IBS

The primary driver of the dicyclomine HCl market is the increasing prevalence of IBS worldwide. IBS affects an estimated 10-15% of the global population, with symptoms such as abdominal pain, bloating, constipation, and diarrhea. This high prevalence is a significant factor driving the demand for dicyclomine HCl[1][4].

Growing Geriatric Population

The growing geriatric population is another key driver. Older adults are more prone to gastrointestinal disorders, which increases the demand for medications like dicyclomine HCl[1].

Rising Healthcare Expenditure

The rise in healthcare expenditure globally is also a significant factor. As healthcare systems invest more in treating gastrointestinal disorders, the demand for dicyclomine HCl is expected to increase[1][4].

Availability of Generic Products

The expiration of patents for branded dicyclomine HCl products has led to the entry of generic manufacturers, offering cost-effective alternatives. This has driven market growth, especially in price-sensitive regions[1][4].

Market Segmentation

By Type

The dicyclomine market is segmented into patent and generic types. Generic drugs, being less expensive, have seen an increase in competition due to the large number of players in the market. Generic dicyclomine HCl products are more affordable and help reduce healthcare costs for patients and healthcare systems[4].

By Application

The market is bifurcated into hospital and drugstore segments. Dicyclomine HCl is widely used in both settings due to the non-life-threatening nature of IBS and the availability of its medication in these outlets[4].

By Geography

The global dicyclomine market is classified into North America, Europe, Asia Pacific, and the rest of the world. North America is currently the largest regional market, driven by the high prevalence of IBS and well-established healthcare infrastructure. The Asia Pacific region is expected to witness the fastest growth during the forecast period due to a large patient population and increasing healthcare expenditure[1][4].

Regional Analysis

North America

North America, particularly the United States, dominates the dicyclomine HCl market due to the high prevalence of IBS and strong awareness about gastrointestinal disorders. The well-established healthcare infrastructure in this region also contributes to its market leadership[1].

Europe

Europe is the second-largest market, with countries like Germany, France, Italy, Spain, and the United Kingdom contributing significantly to regional growth. However, the market growth in Europe may be restrained by the availability of alternative treatment options and stringent regulatory requirements[1].

Asia Pacific

The Asia Pacific region is expected to witness the highest growth during the forecast period. Countries like China, Japan, and India present significant growth opportunities due to a large patient population, increasing prevalence of gastrointestinal disorders, and growing healthcare expenditure[1].

Competitive Landscape

The dicyclomine HCl market is highly competitive with several key players operating globally and regionally. Major players include Allergan plc, Axcan, Lannett, Mutual Pharmaceutical, Mylan, Pioneer Pharmaceuticals, Watson Laboratories, Hikma Pharmaceuticals, Alpharma, and Mikart. These companies are focusing on strategies such as new product launches, geographic expansion, partnerships, and mergers and acquisitions to strengthen their market position[1][4].

Distribution Channels

The retail pharmacy distribution channel segment dominated the market in 2021, as it is the most convenient and accessible channel for patients to obtain dicyclomine HCl products. The tablet dosage form segment also accounted for the largest market share due to its ease of administration and patient preference[1].

Financial Trajectory

The financial trajectory of the dicyclomine HCl market is positive, with significant growth expected over the forecast period. Here are some key financial highlights:

• Market Value: The market was valued at USD 1.5 billion in 2024 and is projected to reach USD 2.7 billion by 2031[4].
• CAGR: The market is growing at a CAGR of 7.3% from 2024 to 2031[4].
• Revenue Growth: The increasing prevalence of IBS, growing geriatric population, and rising healthcare expenditure are driving revenue growth[1][4].

Challenges and Restraints

Despite the positive growth trajectory, the market faces some challenges:

• Lack of Specific Treatment: There is no specific treatment that cures all symptoms associated with IBS, which can restrain market growth[4].
• Competition: The market is highly competitive, especially regarding pricing, which can impact profit margins for manufacturers[4].

Key Takeaways

• The dicyclomine HCl market is driven by the increasing prevalence of IBS, growing geriatric population, and rising healthcare expenditure.
• The market is segmented into patent and generic types, with generic products gaining traction due to cost-effectiveness.
• North America is the largest regional market, but the Asia Pacific region is expected to witness the fastest growth.
• The competitive landscape is dominated by several key players focusing on new product launches and geographic expansion.
• The market is expected to grow at a CAGR of 7.3% from 2024 to 2031.

FAQs

What is the primary use of dicyclomine hydrochloride?

Dicyclomine hydrochloride is primarily used to treat symptoms of irritable bowel syndrome (IBS), such as abdominal pain, cramping, and bloating, by relaxing the smooth muscles in the gut[1][4][5].

Which region dominates the dicyclomine HCl market?

North America, particularly the United States, dominates the dicyclomine HCl market due to the high prevalence of IBS and well-established healthcare infrastructure[1].

What are the key drivers of the dicyclomine HCl market?

The key drivers include the increasing prevalence of IBS, growing geriatric population, and rising healthcare expenditure. The availability of generic dicyclomine HCl products also drives market growth[1][4].

Who are the major players in the dicyclomine HCl market?

Major players include Allergan plc, Axcan, Lannett, Mutual Pharmaceutical, Mylan, Pioneer Pharmaceuticals, Watson Laboratories, Hikma Pharmaceuticals, Alpharma, and Mikart[1][4].

What is the projected market size of dicyclomine HCl by 2031?

The dicyclomine HCl market is projected to reach USD 2.7 billion by 2031, growing at a CAGR of 7.3% from 2024 to 2031[4].

What are the common side effects of dicyclomine hydrochloride?

Common side effects include dry mouth, dizziness, blurry vision, nausea, sleepiness, weakness, nervousness, and abnormal or rapid heart rate. More severe side effects can include allergic reactions and skin problems[5].

Sources

1. DataHorizon Research: Dicyclomine Hcl Market Size, Share & Forecast 2033.
2. University of Maryland Medical System: Standard Charges.
3. Daiichi Sankyo Nordics: Daiichi Sankyo Group Value Report 2018.
4. Verified Market Research: Dicyclomine Market Size, Share, Trends And Forecast.
5. Medicover Hospitals: Dicyclomine Hydrochloride: Uses, Side Effects and Dosage.