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Last Updated: December 22, 2024

DIAZEPAM INTENSOL Drug Patent Profile


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Which patents cover Diazepam Intensol, and what generic alternatives are available?

Diazepam Intensol is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in DIAZEPAM INTENSOL is diazepam. There are eight drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the diazepam profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Diazepam Intensol

A generic version of DIAZEPAM INTENSOL was approved as diazepam by MYLAN on September 4th, 1985.

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Drug patent expirations by year for DIAZEPAM INTENSOL
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Pharmacology for DIAZEPAM INTENSOL
Drug ClassBenzodiazepine

US Patents and Regulatory Information for DIAZEPAM INTENSOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma DIAZEPAM INTENSOL diazepam CONCENTRATE;ORAL 071415-001 Apr 3, 1987 AA RX No Yes ⤷  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

DIAZEPAM INTENSOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diazepam Intensol

Overview of Diazepam Intensol

Diazepam Intensol, a concentrated oral solution of diazepam, is a benzodiazepine used for managing anxiety disorders, acute alcohol withdrawal, muscle spasms, and seizures. Understanding its market dynamics and financial trajectory is crucial for stakeholders in the pharmaceutical industry.

Market Size and Growth

The global diazepam market, which includes Diazepam Intensol, was valued at USD 1.01 billion in 2019 and is projected to reach USD 1.31 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of 3.4% during the forecast period[1].

By 2023, the market size had already increased to USD 1.28 billion and is expected to grow further to USD 1.51 billion by 2031, with a CAGR of 3.6% from 2024 to 2031[3].

Key Drivers of Market Growth

Rising Incidences of Anxiety Disorders and Other Conditions

The increasing prevalence of anxiety disorders, insomnia, and alcohol addiction are significant drivers of the diazepam market. These conditions are becoming more common, leading to higher demand for effective treatments like Diazepam Intensol[1].

Investments in Research and Development

Substantial investments in research and development, including new product launches and ongoing clinical trials, are boosting the market. These trials explore additional applications of diazepam, such as treating high tone pelvic floor dysfunction and behavioral emergencies[1].

Increasing Awareness and Safe Application

Growing awareness about the safe application of diazepam and its multiple uses contributes to market growth. Public education campaigns and improved diagnosis methods are also factors[1].

Geographical Opportunities

Emerging markets in Asia-Pacific and Latin America offer lucrative growth opportunities due to improved access to healthcare services and medications in these regions[1].

Market Segmentation

Form of Medication

The market is segmented by form of medication, with tablets being the chief revenue-generating segment. However, the rectal gel type segment is also expected to grow, with a CAGR of 3.3% during the forecast period[1].

Applications

Diazepam Intensol is used for various applications, including anxiety disorders, alcohol withdrawal, muscle spasms, seizures, sedation, and insomnia. These diverse applications contribute to its market growth[1].

End-Users

The market is segmented by end-users, including geriatric, pediatric, and adult populations. Each segment has different needs and usage patterns, influencing market dynamics[1].

Regional Outlook

North America

North America remains the key revenue-generating geographical segment, driven by factors such as the availability of research funds, awareness about mental disorders, state-of-the-art medications, and favorable reimbursements for mental disorder treatments[1].

Other Regions

Asia-Pacific and Latin America are emerging as significant markets due to improving healthcare infrastructure and increasing awareness about mental health issues[1].

Market Competition

The global diazepam market is highly fragmented, with major players like Pfizer, F.Hoffmann-La Roche, Mylan, Teva Pharmaceutical Industries, and others. The presence of generic versions of diazepam and alternative treatments affects market share and pricing[1].

Financial Considerations

Pricing and Affordability

The affordability of diazepam and its coverage by insurance plans significantly influence market penetration. For example, the cost for diazepam 5 mg oral tablets can range from $9 to $11 for a supply of 4-10 tablets, depending on the pharmacy and location[5].

Insurance Coverage and Reimbursement

Improvements in the reimbursement scenario for mental disorder treatments also drive market growth. However, variations in insurance coverage can impact the demand for Diazepam Intensol[1].

Challenges and Restraints

Regulatory Factors

Stringent regulations regarding approvals and the potential for side effects, withdrawal symptoms, and drug-drug interactions are major factors restraining market growth. Rare but serious cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) and other adverse reactions also pose challenges[1][2].

Public Awareness and Education

Limited awareness about mental health disorders and the lack of improved diagnosis methods can hinder market growth. However, increasing public awareness and education campaigns are helping to mitigate these issues[1].

Clinical Trials and Research

Numerous clinical trials are ongoing to test the effects of diazepam on various disorders, including high tone pelvic floor dysfunction, behavioral emergencies, and epilepsy. These trials are crucial for expanding the therapeutic applications of diazepam and driving market growth[1].

Side Effects and Safety Concerns

Common side effects of diazepam include drowsiness, fatigue, muscle weakness, and ataxia. More severe side effects, such as central nervous system disturbances, gastrointestinal issues, and psychiatric reactions, also need to be considered when prescribing Diazepam Intensol[4].

Key Takeaways

  • The global diazepam market is expected to grow significantly, driven by increasing incidences of anxiety disorders and other conditions.
  • Investments in research and development, along with growing awareness and safe application practices, are key drivers.
  • The market is segmented by form of medication, application, end-user, and region, with North America being the leading geographical segment.
  • Financial considerations, including pricing and insurance coverage, play a crucial role in market dynamics.
  • Despite challenges such as regulatory factors and side effects, ongoing clinical trials and public awareness campaigns are expected to boost market growth.

FAQs

What is the projected market size for diazepam by 2027?

The global diazepam market is expected to reach USD 1.31 billion by 2027, growing at a CAGR of 3.4% from 2019[1].

What are the primary applications of Diazepam Intensol?

Diazepam Intensol is used for managing anxiety disorders, acute alcohol withdrawal, muscle spasms, seizures, sedation, and insomnia[1][4].

Which region is the largest market for diazepam?

North America is the key revenue-generating geographical segment for the diazepam market, driven by factors such as research funds, awareness, and favorable reimbursements[1].

What are the major side effects of Diazepam Intensol?

Common side effects include drowsiness, fatigue, muscle weakness, and ataxia. More severe side effects can include central nervous system disturbances, gastrointestinal issues, and psychiatric reactions[4].

How does the affordability of diazepam impact its market?

The affordability of diazepam, influenced by pricing and insurance coverage, significantly affects its market penetration and overall demand[3][5].

What are the ongoing clinical trials for diazepam focused on?

Ongoing clinical trials are exploring additional applications of diazepam, such as treating high tone pelvic floor dysfunction, behavioral emergencies, and epilepsy[1].

Sources

  1. Biospace: Diazepam Market Analysis By Key Players, Share, Size, Trends, Aftermarket Growth Opportunities, and Regional Forecast to 2027.
  2. Colorado Department of Health Care Policy and Financing: DUR Board Minutes - February 2024.
  3. Verified Market Research: Diazepam Market Size, Share, Trends & Forecast.
  4. RxList: Diazepam Intensol - RxList.
  5. Drugs.com: Diazepam Prices, Coupons, Copay Cards & Patient Assistance.

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