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, Rising, 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, Novitium Pharma, Ph Health, Bionpharma, Hikma Pharms, and Rubicon Research, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for DICYCLOMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	30
NDAs:	45
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	1,871
What excipients (inactive ingredients) are in DICYCLOMINE HYDROCHLORIDE?	DICYCLOMINE HYDROCHLORIDE excipients list
DailyMed Link:	DICYCLOMINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DICYCLOMINE HYDROCHLORIDE

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

Sponsor	Phase
Friends Research Institute, Inc.	PHASE4
MATClinics	PHASE4

See all DICYCLOMINE HYDROCHLORIDE clinical trials

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
Pioneer Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	089361-001	Jan 10, 1989		DISCN	No	No
Renew Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	207084-001	May 4, 2018		DISCN	No	No
Twi Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	216782-001	Jun 1, 2023	AB	RX	No	No

Market Dynamics and Financial Trajectory for Dicyclomine Hydrochloride

Last updated: July 28, 2025

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Introduction

Dicyclomine hydrochloride is a well-established anticholinergic agent primarily prescribed for the symptomatic relief of irritable bowel syndrome (IBS). Since its approval decades ago, it has maintained a significant position in gastrointestinal therapeutics. This comprehensive analysis examines the current market dynamics, competitive landscape, regulatory environment, and future financial outlook for dicyclomine hydrochloride within the pharmaceutical industry.

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Market Overview and Current Landscape

Global Market Size and Segments

The global gastrointestinal (GI) disorder treatment market is burgeoning, driven by increasing prevalence of IBS and related disorders. The market value was estimated at approximately USD 12.2 billion in 2021, with a compound annual growth rate (CAGR) of around 4.5% projected through 2028 [1]. Dicyclomine hydrochloride specifically targets the symptomatic relief within this segment, contributing significantly to the antispasmodic therapies market, valued at roughly USD 2.7 billion in 2022 [2].

Market Penetration and Usage Trends

Dicyclomine has historically been a first-line therapy for IBS, especially among adult populations. Its longstanding presence and proven efficacy have fostered widespread clinical acceptance. Nonetheless, newer agents such as hyoscyamine and peppermint oil are increasingly gaining attention, partly due to perceptions of fewer side effects and better tolerance profiles. Despite this, the drug continues to be prescribed routinely owing to its robust clinical profile and geographic presence, particularly in North America and Europe.

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Market Drivers

• Increasing IBS Prevalence
  IBS affects approximately 10-15% of the global population, with rising detection owing to improved diagnostic criteria and awareness [3]. This prevalence propels demand for antispasmodic agents like dicyclomine.

• Healthcare Infrastructure Expansion
  Developing economies see expanding healthcare infrastructure, contributing to broader access and higher prescription rates.

• Established Efficacy and Safety Profile
  Dicyclomine has decades of clinical use, fostering clinician confidence and consistent prescribing patterns.

• Generic Availability and Pricing Strategies
  The entry of generic formulations has substantially lowered costs, facilitating market penetration, especially in price-sensitive markets.

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Market Restraints

• Side-Effect Profile and Safety Concerns
  Anticholinergic side effects such as dry mouth, blurred vision, and urinary retention restrict usage in certain patient groups, especially the elderly.

• Competition from Alternative Therapies
  Newer drugs with improved side-effect profiles or targeted mechanisms are eroding market share.

• Regulatory and Patent Landscape
  As a longstanding generic drug, dicyclomine faces limited patent protections, impacting R&D investments and pricing power.

• Limited Indication Expansion
  Unlike some newer drugs, dicyclomine's use is mostly confined to IBS, limiting revenue diversification.

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Regulatory Environment

Approvals and Patent Status

Dicyclomine was initially approved in the United States in the 1960s. Its patent exclusivity has long expired, categorizing it as a generic pharmaceuticals product. This status influences pricing strategies and market entry, allowing multiple manufacturers to produce and sell the drug globally.

Regulatory Challenges

Regulatory agencies increasingly emphasize drug safety and post-marketing surveillance. While dicyclomine’s safety record remains robust, ongoing reviews could impact formulations or recommended dosages, influencing market dynamics.

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Competitive Landscape

Major Players

• AbbVie (formerly known as Abbott)
  Historically, a significant producer of dicyclomine in the US.

• Align Technology, Inc.
  Offers generic formulations across markets.

• Local manufacturers in emerging economies bolster accessibility.

Emerging Alternatives

• Hyoscyamine and peppermint oil are gaining traction as alternatives with favorable side-effect profiles.

• Novel therapeutics targeting IBS, such as rifaximin and eluxadoline, are expanding the treatment landscape.

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Financial Trajectory and Revenue Forecast

Given its current status as a mature, off-patent product, dicyclomine’s revenue streams are primarily driven by generic sales. The global generic gastrointestinal drugs market is projected to grow modestly, aligned with overall IBS prevalence and increased healthcare spending.

Projected Revenue Trends (2023-2030):

• Stable Revenue Base:
  For established markets like North America and Europe, revenues are expected to stabilize. Price erosion due to generic competition is a persistent challenge.

• Moderate Growth in Emerging Markets:
  Rapid healthcare infrastructure growth and rising IBS awareness are likely to fuel market expansion, with compounded annual growth rates estimated at 2-4%.

• Impact of Patent Expirations:
  The expiration of any residual patents or exclusivity rights may trigger price drops but increase volume sales.

• Potential Reformulation or Indication Expansion:
  Any future regulatory approval for alternative indications or reformulations could provide revenue uplift, although such developments are currently limited.

Key Factors Influencing Financial Trajectory:

• Pricing pressures and market competition
• Regulatory policies affecting generics
• Physician and patient preferences for newer agents

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Future Outlook and Strategic Considerations

Market Sustainability

While dicyclomine’s core market remains stable, its growth prospects are constrained by the proliferation of newer therapies and the commodification of generic drugs. Manufacturers should consider diversification strategies, including formulation innovations, combination therapies, or exploring new indications to sustain revenue streams.

Innovation and R&D

Investing in reformulations that reduce side effects or developing combination drugs could extend its relevance. Additionally, leveraging digital health tools can improve patient adherence and outcomes, benefiting long-term market presence.

Regulatory and Policy Impacts

Monitoring evolving regulations regarding safety assessments, pricing policies, and patent laws will be critical. Strategic alignment with health authorities can facilitate smoother market access and pricing negotiations.

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Key Takeaways

• Stable Demand Amidst Competition: Dicyclomine hydrochloride continues to be a cornerstone in IBS management, with steady global demand, particularly in mature markets.

• Pricing and Generics: As a generic drug, revenue growth relies on volume sales and market penetration rather than pricing premiums.

• Market Challenges: Side-effect concerns and competition from alternatives limit upward growth; innovation remains essential.

• Regional Opportunities: Emerging markets offer growth potential due to increased healthcare access and IBS awareness, albeit with price sensitivity considerations.

• Strategic Focus: Ongoing surveillance of regulatory developments, potential for formulation improvements, and diversification are key to sustaining financial performance.

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FAQs

1. What are the primary therapeutic uses of dicyclomine hydrochloride?
Dicyclomine is mainly used to relieve symptoms of irritable bowel syndrome (IBS), including abdominal pain and cramping, by relaxing intestinal muscles.

2. How does the patent status of dicyclomine influence its market?
Being off-patent, dicyclomine is available as a generic, leading to intense price competition but also broad accessibility, limiting the potential for new patent-based revenue.

3. What are the main competitors to dicyclomine in the IBS treatment market?
Competitors include hyoscyamine, peppermint oil, and newer agents like rifaximin and eluxadoline, which offer alternative mechanisms and potentially fewer side effects.

4. How might regulatory changes affect the future of dicyclomine?
Strict safety regulations or new labeling requirements could impact prescribing practices or limit use, affecting revenue streams. Conversely, approvals for new indications could boost sales.

5. What strategic actions can manufacturers take to extend the market life of dicyclomine?
Manufacturers should explore reformulations with improved tolerability, investigate additional indications, and leverage digital health solutions to enhance patient adherence.

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References

[1] Market Research Future. (2022). Gastrointestinal Drugs Market Analysis.
[2] Grand View Research. (2022). Global Gastrointestinal Drugs Market Size & Trend.
[3] Craig, B., et al. (2020). Epidemiology of IBS. Gastroenterology & Hepatology.