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Last Updated: December 22, 2024

BENTYL Drug Patent Profile


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Summary for BENTYL
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Pharmacology for BENTYL
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for BENTYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan BENTYL dicyclomine hydrochloride CAPSULE;ORAL 007409-003 Oct 15, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Allergan BENTYL dicyclomine hydrochloride TABLET;ORAL 007409-001 Oct 15, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie BENTYL dicyclomine hydrochloride INJECTABLE;INJECTION 008370-001 Oct 15, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Aptalis Pharma Us BENTYL dicyclomine hydrochloride SYRUP;ORAL 007961-002 Oct 15, 1984 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: BENTYL

Introduction

BENTYL, also known as dicyclomine, is a medication used to treat spasms of the intestines, particularly those associated with irritable bowel syndrome (IBS). Here, we will delve into the market dynamics and financial trajectory of this drug.

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[1].

Drivers of Market Growth

Several factors are driving the growth of the dicyclomine market:

Increasing Prevalence of Gastrointestinal Diseases

The rising prevalence of gastrointestinal diseases and disorders, such as IBS, is a major driver. IBS is one of the most common gastrointestinal problems, and its increasing prevalence among the population is boosting the demand for dicyclomine[1].

Unhealthy Eating Habits and Stress

Unhealthy eating habits, such as the consumption of frozen and fast food, and increasing stress levels among the population also contribute to the demand for dicyclomine. Stress can exacerbate gastrointestinal issues, making dicyclomine a necessary treatment option[1].

Government Initiatives and Awareness

Government campaigns and initiatives to raise awareness about the treatment of IBS further enhance market growth. Increased healthcare expenditure and the growth of the healthcare industry worldwide are additional drivers[1].

Market Segmentation

The global dicyclomine market is segmented based on type, application, and geography.

By Type

The market is bifurcated into patent and generic drugs. Generic drugs, being less expensive, have seen an increase in competition due to the presence of multiple players in the market. This segment is expected to grow significantly as generic manufacturers continue to enter the market[1].

By Application

The market is segmented into hospitals and drugstores. Since IBS is not a life-threatening condition, its medication is widely available and used in both settings[1].

By Geography

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

Key Players

Major players in the dicyclomine market include Axcan, Lannett, Mutual Pharmaceutical, Mylan, Pioneer Pharmaceuticals, Watson Laboratories, Hikma Pharmaceuticals, Alpharma, and Mikart. These companies are key in driving market growth through their competitive strategies and market share[1].

Financial Performance and Competitive Landscape

The financial performance of these companies is closely tied to their market share and competitive strategies. The competitive landscape section of market reports includes key development strategies, market share analysis, and market ranking of these players globally[1].

Challenges and Restraints

Despite the growth potential, the market faces some challenges:

Lack of Specific Treatment

The lack of a specific treatment that cures all symptoms associated with IBS can restrain market growth. Additionally, competition among players regarding pricing can also impact the market negatively[1].

Regulatory and Antitrust Issues

Historically, antitrust concerns have played a role in shaping the market. For example, in 1994, the US Federal Trade Commission ordered Marion Merrell Dow to grant licenses to its intellectual property on dicycloverine to other companies, which led to increased generic competition[4].

Clinical and Usage Aspects

BENTYL is indicated for the treatment of patients with functional bowel/irritable bowel syndrome. It is administered orally or intramuscularly, with dosages adjusted to individual patient needs. The common dosage starts at 20 mg four times a day and can be escalated to 40 mg four times a day unless side effects limit the dosage escalation[5].

Side Effects and Safety

Common side effects of BENTYL include dry mouth, blurred vision, weakness, sleepiness, and lightheadedness. Serious side effects may include psychosis and breathing problems in babies. The drug should be used with caution in certain patient groups, such as those with myasthenia gravis, incomplete intestinal obstruction, and ulcerative colitis[5].

Market Impact of Generic Entry

The entry of generic competitors has significantly impacted the market. By 2000, several generic competitors had started selling dicycloverine, following the licensing agreements mandated by antitrust regulations. This has made the drug more accessible and affordable, contributing to market growth[4].

Future Outlook

Given the increasing prevalence of gastrointestinal diseases and the growing healthcare expenditure, the dicyclomine market, including BENTYL, is poised for continued growth. However, companies must navigate the challenges of pricing competition and regulatory environments to maintain their market share.

Key Takeaways

  • The dicyclomine market is projected to grow from USD 1.5 billion in 2024 to USD 2.7 billion by 2031.
  • Increasing prevalence of gastrointestinal diseases, unhealthy eating habits, and stress are key drivers.
  • Generic drugs and government initiatives are significant factors in market growth.
  • Major players include Axcan, Lannett, Mutual Pharmaceutical, and others.
  • Challenges include the lack of specific treatment for IBS and pricing competition.

FAQs

What is the primary use of BENTYL?

BENTYL is primarily used to treat spasms of the intestines, particularly those associated with irritable bowel syndrome (IBS).

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

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

What are the common side effects of BENTYL?

Common side effects include dry mouth, blurred vision, weakness, sleepiness, and lightheadedness.

Which regions present the most lucrative growth opportunities for the dicyclomine market?

The Asia Pacific region presents the most lucrative growth opportunities due to its large population and increasing healthcare needs.

How has the entry of generic competitors impacted the dicyclomine market?

The entry of generic competitors has made the drug more accessible and affordable, contributing to market growth and increased competition.

Sources

  1. Verified Market Research - Dicyclomine Market Size, Share, Trends And Forecast
  2. Bentley University - Drug Reduction Dashboard
  3. CBAX - What Do Science Publications and Websites Have in Common?
  4. Wikipedia - Dicycloverine
  5. FDA - Bentyl (dicyclomine hydrochloride) capsules label

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