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Last Updated: December 21, 2024

Anisotropine methylbromide - Generic Drug Details


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What are the generic drug sources for anisotropine methylbromide and what is the scope of patent protection?

Anisotropine methylbromide is the generic ingredient in two branded drugs marketed by Watson Labs and Endo Pharms, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for anisotropine methylbromide.

Summary for anisotropine methylbromide

US Patents and Regulatory Information for anisotropine methylbromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Endo Pharms VALPIN 50 anisotropine methylbromide TABLET;ORAL 013428-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Watson Labs ANISOTROPINE METHYLBROMIDE anisotropine methylbromide TABLET;ORAL 086046-001 Approved Prior to Jan 1, 1982 DISCN No 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

Anisotropine methylbromide Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Anisotropine Methylbromide

Introduction

Anisotropine methylbromide, also known as octatropine methylbromide, is a muscarinic antagonist and antispasmodic that was introduced to the U.S. market in 1963. Initially, it was used as an adjunct in the treatment of peptic ulcer disease. Here, we will delve into the market dynamics and financial trajectory of this drug.

Historical Context and Introduction

Anisotropine methylbromide was promoted as being more specific to the gastrointestinal tract than other anticholinergics when it was first introduced. It was marketed under various trade names, including Valpin, Endovalpin, and Lytispasm[4].

Clinical Use and Mechanism of Action

The drug was used in conjunction with antacids or histamine H2-receptor antagonists to reduce further gastric acid secretion and delay gastric emptying in the treatment of peptic ulcers. It works by inhibiting the muscarinic actions of acetylcholine on smooth muscles and autonomic effector cells, thereby reducing the motility and secretory activity of the gastrointestinal system[1][4].

Market Reception and Initial Success

Upon its introduction, anisotropine methylbromide saw some success due to its perceived specificity to the gastrointestinal tract. However, later studies questioned its selectivity, and its use began to decline as more effective agents were developed[4].

Decline in Use and Market Share

Over time, anisotropine methylbromide has been superseded by more effective treatments for peptic ulcer disease. This shift has significantly reduced its market share and usage. The drug is no longer a primary treatment option in many countries and is largely replaced by more modern and effective medications[1][4].

Current Market Status

Although anisotropine methylbromide is no longer widely used for peptic ulcer treatment, it is still available in some countries, often in combination with other drugs such as phenobarbital and metamizole. This limited use contributes to a diminished market presence and reduced financial returns compared to its peak in the 1960s and 1970s[4].

Financial Trajectory

Initial Revenue and Growth

When first introduced, anisotropine methylbromide generated significant revenue due to its novelty and perceived advantages over existing treatments. The drug's initial success led to substantial financial gains for the pharmaceutical companies involved in its production and distribution.

Decline in Revenue

As more effective treatments emerged and the drug's selectivity was questioned, the revenue generated by anisotropine methylbromide began to decline. The market share of the drug decreased, leading to reduced sales and lower financial returns.

Current Financial Standing

Today, the financial trajectory of anisotropine methylbromide is characterized by minimal revenue. The drug's limited use and availability in only a few countries mean that it no longer contributes significantly to the pharmaceutical industry's financial landscape.

Impact of Generic Competition

The generic drug industry dynamics play a crucial role in the financial trajectory of drugs like anisotropine methylbromide. When a drug's patent expires, generic versions can enter the market, leading to increased competition and lower prices. However, since anisotropine methylbromide has been largely replaced by more effective treatments, the impact of generic competition on its financial trajectory is minimal[3].

Regulatory and Policy Influences

Changes in regulatory policies, such as increased FDA scrutiny of generic drug applications, can affect the cost and complexity of bringing new drugs to market. However, these changes have had little direct impact on anisotropine methylbromide, as it is no longer a significant player in the market[3].

Bioavailability and Pharmacokinetics

The poor and irregular gastrointestinal absorption of anisotropine methylbromide, with a bioavailability of only 10 to 25%, has been a factor in its limited efficacy and subsequent decline in use. The hepatic metabolism and unknown elimination half-life further complicate its pharmacokinetic profile[1][4].

Conclusion on Market Dynamics

The market dynamics for anisotropine methylbromide are characterized by a decline in use and revenue due to the availability of more effective treatments. The drug's limited current use and availability in only a few countries reflect its diminished market presence.

Key Takeaways

  • Introduction and Initial Success: Anisotropine methylbromide was introduced in 1963 as a treatment adjunct for peptic ulcers.
  • Decline in Use: The drug has been superseded by more effective agents, leading to a decline in its market share and usage.
  • Current Market Status: It is still available in some countries but in limited capacity.
  • Financial Trajectory: The drug's revenue has significantly declined over the years.
  • Impact of Generic Competition: Minimal impact due to its replacement by more effective treatments.
  • Regulatory Influences: Changes in regulatory policies have had little direct impact on the drug.

FAQs

What is anisotropine methylbromide used for?

Anisotropine methylbromide was used as an adjunct in the treatment of peptic ulcers to reduce further gastric acid secretion and delay gastric emptying.

Why has the use of anisotropine methylbromide declined?

The use of anisotropine methylbromide has declined due to the availability of more effective treatments for peptic ulcer disease.

What is the bioavailability of anisotropine methylbromide?

The bioavailability of anisotropine methylbromide is about 10 to 25% when administered orally.

Is anisotropine methylbromide still available in the market?

Yes, anisotropine methylbromide is still available in some countries, often in combination with other drugs.

What are the trade names of anisotropine methylbromide?

The trade names include Valpin, Endovalpin, and Lytispasm.

Sources

  1. DrugBank: Anisotropine methylbromide: Uses, Interactions, Mechanism of Action.
  2. CDC: 2005 nhamcs micro-data file documentation.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. Wikipedia: Octatropine methylbromide.
  5. DrugBank: Azabicyclo Compounds.

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