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Last Updated: December 22, 2024

BENTYL PRESERVATIVE FREE Drug Patent Profile


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Which patents cover Bentyl Preservative Free, and what generic alternatives are available?

Bentyl Preservative Free is a drug marketed by Abbvie and is included in one NDA.

The generic ingredient in BENTYL PRESERVATIVE FREE is dicyclomine hydrochloride. There are four drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the dicyclomine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Bentyl Preservative Free

A generic version of BENTYL PRESERVATIVE FREE was approved as dicyclomine hydrochloride by WATSON LABS on June 19th, 1986.

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Summary for BENTYL PRESERVATIVE FREE
Drug patent expirations by year for BENTYL PRESERVATIVE FREE
Pharmacology for BENTYL PRESERVATIVE FREE
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for BENTYL PRESERVATIVE FREE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie BENTYL PRESERVATIVE FREE dicyclomine hydrochloride INJECTABLE;INJECTION 008370-002 Oct 15, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BENTYL PRESERVATIVE FREE Market Analysis and Financial Projection Experimental

Dicyclomine Market Dynamics and Financial Trajectory: A Comprehensive Overview

Introduction to Dicyclomine and BENTYL

Dicyclomine, marketed under the brand name BENTYL, is a muscarinic M1 and M2 receptor antagonist, as well as a non-competitive inhibitor of histamine and bradykinin. It is primarily used to treat spasms of the intestines associated with functional bowel disorders and irritable bowel syndrome (IBS)[3].

Market Size and Forecast

The dicyclomine market, which includes BENTYL, is projected to experience significant growth. As of 2024, the market size was valued at USD 1.5 billion and is expected to reach USD 2.7 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 7.3% during the forecast period of 2024-2031[1].

Key Drivers of Market Growth

Increasing Prevalence of Gastrointestinal Diseases

The rising prevalence of gastrointestinal diseases and disorders, such as irritable bowel syndrome, is a major driver of the dicyclomine market. Unhealthy eating habits, including the consumption of frozen and fast food, contribute to abdominal pain and other gastrointestinal issues, thereby increasing the demand for dicyclomine[1].

Growing Stress Levels

Increased stress levels among the population also drive the demand for dicyclomine. Stress can exacerbate gastrointestinal symptoms, and dicyclomine's role in relaxing muscles makes it a sought-after treatment[1].

Government Initiatives and Awareness Campaigns

Government initiatives and awareness campaigns aimed at enhancing healthcare facilities and educating consumers about the treatment of irritable bowel syndrome further boost the market growth. These efforts increase the visibility and acceptance of dicyclomine as a treatment option[1][3].

Healthcare Expenditure and Industry Growth

The global increase in healthcare expenditure and the growth of the healthcare industry also contribute to the market's financial trajectory. As healthcare systems expand and more resources are allocated to treating chronic conditions, the demand for effective treatments like dicyclomine rises[1].

Market Segmentation

By Type

The dicyclomine market is segmented into patent and generic types. Generic drugs, being less expensive due to the absence of development and marketing costs, have seen an increase in competition. This segment is expected to grow as more generic versions of dicyclomine become available[1][3].

By Application

The market is also segmented by application into hospitals and drugstores. Given that irritable bowel syndrome is not a life-threatening condition, medications like dicyclomine are widely available and used in both settings[1].

By Geography

Geographically, the market is classified into North America, Europe, Asia Pacific, and the Rest of the world. The Asia Pacific region is identified as having lucrative growth opportunities due to its large population and increasing healthcare needs[1][3].

Competitive Landscape

The dicyclomine market is highly competitive, with several key players such as Axcan, Lannett, Mutual Pharmaceutical, Mylan, Pioneer Pharmaceuticals, Watson Laboratories, Hikma Pharmaceuticals, Alpharma, and Mikart. These companies are engaged in various strategies to maintain market share, including product development and pricing competitions[1].

Challenges and Restraints

Lack of Specific Treatment

One of the significant restraints is the lack of a specific treatment that can cure all symptoms associated with irritable bowel syndrome. This limitation can hinder the market's growth as patients may seek alternative treatments[1].

Pricing Competition

Competition among players regarding pricing is another challenge. The presence of generic drugs can lead to price wars, which may affect the profitability of patented drugs[1].

Adverse Reactions and Contraindications

Dicyclomine has several adverse reactions and contraindications, such as cardiovascular and central nervous system symptoms, which can limit its use in certain patient populations. For example, it should be used with caution in patients with prostatic hypertrophy, hepatic and renal disease, and geriatric patients[2].

Regional Framework and Market Opportunities

Asia Pacific

The Asia Pacific region offers significant growth opportunities due to its large and growing population, increasing healthcare expenditure, and rising awareness about gastrointestinal disorders. This region is expected to be a key driver of the market's financial trajectory[1][3].

Government Initiatives and Research Funding

Government initiatives to enhance healthcare facilities and increase research funding are expected to provide opportunities for the dicyclomine market. These initiatives can lead to better treatment options and increased accessibility of dicyclomine[3].

Financial Trajectory

The financial trajectory of the dicyclomine market is positive, driven by the factors mentioned above. Here are some key financial highlights:

  • Market Size: Expected to grow from USD 1.5 billion in 2024 to USD 2.7 billion by 2031.
  • CAGR: Projected to grow at a CAGR of 7.3% from 2024-2031.
  • Revenue Growth: Driven by increasing demand, government initiatives, and the growth of the healthcare industry[1].

Key Takeaways

  • The dicyclomine market is driven by the increasing prevalence of gastrointestinal diseases and disorders.
  • Government initiatives and awareness campaigns are crucial for market growth.
  • The Asia Pacific region offers significant growth opportunities.
  • The market faces challenges such as the lack of specific treatment for all IBS symptoms and pricing competition.
  • Adverse reactions and contraindications need careful consideration in the use of dicyclomine.

FAQs

What is the primary use of dicyclomine?

Dicyclomine is primarily used to treat spasms of the intestines associated with functional bowel disorders and irritable bowel syndrome (IBS)[3].

What is the projected market size of dicyclomine by 2031?

The dicyclomine market is projected to reach USD 2.7 billion by 2031[1].

What are the key drivers of the dicyclomine market?

Key drivers include the increasing prevalence of gastrointestinal diseases, growing stress levels, government initiatives, and the growth of the healthcare industry[1][3].

Which region offers the most significant growth opportunities for dicyclomine?

The Asia Pacific region is identified as having lucrative growth opportunities due to its large population and increasing healthcare needs[1][3].

What are some of the challenges faced by the dicyclomine market?

Challenges include the lack of specific treatment for all IBS symptoms, pricing competition, and adverse reactions and contraindications associated with dicyclomine[1][2].

Sources

  1. Verified Market Research: Dicyclomine Market Size, Share, Trends And Forecast[1].
  2. FDA: Bentyl (dicyclomine hydrochloride) capsules label[2].
  3. The Insight Partners: Dicyclomine Market Opportunities 2031[3].

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