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Last Updated: December 27, 2024

VALIUM Drug Patent Profile


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Which patents cover Valium, and what generic alternatives are available?

Valium is a drug marketed by Roche and Waylis Therap and is included in two NDAs.

The generic ingredient in VALIUM 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 Valium

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

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Summary for VALIUM
Drug patent expirations by year for VALIUM
Drug Prices for VALIUM

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Recent Clinical Trials for VALIUM

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

SponsorPhase
Mayo ClinicPhase 1/Phase 2
Canadian Institutes of Health Research (CIHR)N/A
Centre for Addiction and Mental HealthN/A

See all VALIUM clinical trials

Pharmacology for VALIUM
Drug ClassBenzodiazepine

US Patents and Regulatory Information for VALIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-006 Approved Prior to Jan 1, 1982 AB RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-002 Approved Prior to Jan 1, 1982 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-004 Approved Prior to Jan 1, 1982 AB RX 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

Expired US Patents for VALIUM

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche VALIUM diazepam INJECTABLE;INJECTION 016087-001 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-006 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-002 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Subscribe
Waylis Therap VALIUM diazepam TABLET;ORAL 013263-004 Approved Prior to Jan 1, 1982 4,316,897 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

VALIUM Market Analysis and Financial Projection Experimental

Benzodiazepine Drugs Market: Focus on Valium (Diazepam)

Market Overview

The benzodiazepine drugs market, which includes Valium (diazepam), is experiencing significant growth driven by several key factors. Here’s a detailed look at the market dynamics and financial trajectory of diazepam.

Market Size and Forecast

The global diazepam market has been steadily growing and is projected to continue this trend. As of 2023, the market size was valued at USD 1.28 billion and is expected to reach USD 1.51 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 3.6% during the forecast period of 2024-2031[3].

Geographic Segmentation

North America

North America, particularly the United States, is a major driver of demand for diazepam due to the high prevalence of anxiety and related disorders. The region benefits from a well-established healthcare infrastructure and the availability of prescription medications. In 2018, North America held the largest share of 38.3% in the diazepam industry[3].

Europe

Europe is another significant region for the diazepam market. However, long-term use of benzodiazepines in this region is often associated with side effects such as memory loss, Alzheimer's disease, dependence, and increased risk of falls and traffic accidents, which can limit market growth[3].

Asia-Pacific

The Asia-Pacific region is expected to show the highest growth in the coming years due to increasing awareness of mental health and improving access to healthcare[4].

Product Segmentation

The diazepam market is segmented based on the form of medication:

Tablets

The tablet segment is expected to lead in revenue generation due to its widespread use and convenience. Tablets are the most common form of diazepam and are preferred for their ease of administration[3].

Oral Solution and Rectal Gel

Oral solution and rectal gel forms are also significant, with the oral solution segment expected to grow at a CAGR of 2.9% during the forecast period. These forms are particularly useful for patients who have difficulty swallowing tablets[3].

Key Drivers of Market Growth

Rising Incidences of Anxiety Disorders

The increasing prevalence of anxiety disorders, insomnia, and alcohol addiction is a major driver of the diazepam market. These conditions are becoming more common due to factors such as urbanization and the present work culture, which have significantly increased mental health problems[1][4].

Investments in Research & Development

Investments in healthcare R&D have led to the introduction of novel synthesized benzodiazepines, which are expected to have minimal side effects. This development is anticipated to lead to higher acceptance and growth in the market during the medium term (2025 to 2028)[3].

New Product Launches and Clinical Trials

New product launches and ongoing clinical trials are also contributing to the high CAGR of the diazepam market. These initiatives increase awareness for the safe application of diazepam and other benzodiazepines[4].

Market Challenges

Regulatory Constraints

Regulatory environments play a crucial role in the benzodiazepine market. Strict regulations and the need for FDA approvals can slow down market growth. However, companies like Aquestive Therapeutics are successfully navigating these regulatory hurdles and achieving approvals, such as the recent FDA approval for Libervant[2][5].

Side Effects and Dependence

Long-term use of benzodiazepines, including diazepam, is associated with significant side effects such as memory loss, Alzheimer's disease, dependence, and addiction. These factors can limit market growth and necessitate the development of safer alternatives[3].

Alternative Treatments

Shifts towards non-benzodiazepine treatments and the presence of generic versions of diazepam can affect market share and pricing. The availability of alternative treatments can reduce the demand for traditional benzodiazepines[3].

Key Players and Market Competition

The diazepam market is characterized by the presence of several key players:

  • Pfizer Inc.
  • Akorn Inc.
  • Hikma
  • Hameln Pharmaceutical
  • Amneal Pharmaceuticals LLC

These companies are actively involved in R&D, new product launches, and strategic collaborations to maintain their market positions[3].

Financial Trajectory

The financial trajectory of the diazepam market is marked by steady growth. Here are some key financial projections:

  • Projected Market Value: The market is expected to reach USD 1.51 billion by 2031, growing at a CAGR of 3.6% from 2024 to 2031[3].
  • Regional Expenditure: In regions like Croatia, the total projected financial expenditure for benzodiazepines, including diazepam, is estimated to be significant, with diazepam and alprazolam expenditures predicted to be 7.39 and 4.12 million euros, respectively, by 2032[3].

Technological Advancements and R&D

Investments in healthcare R&D have been instrumental in the development of novel synthesized benzodiazepines with minimal side effects. This development is expected to lead to higher acceptance and growth in the market during the medium term (2025 to 2028)[3].

"Over the last several quarters, we have reduced our cash burn, refinanced our debt, significantly strengthened our cash position, attracted high quality institutional healthcare investors, successfully completed our Anaphylm Phase 3 study, and received FDA approval for Libervant in patients between ages 2 to 5." - Daniel Barber, Chief Executive Officer of Aquestive[2].

Key Takeaways

  • The diazepam market is projected to grow at a CAGR of 3.6% from 2024 to 2031.
  • North America and Europe are key regions driving demand, while the Asia-Pacific region is expected to show the highest growth.
  • Improved access to healthcare and public awareness are significant drivers.
  • Regulatory and side effect concerns are major restraints.
  • The market is segmented by product form, with tablets leading in revenue generation.

Frequently Asked Questions (FAQs)

Q: What is the projected market value of the diazepam market by 2031?

The diazepam market is expected to reach USD 1.51 billion by 2031, growing at a CAGR of 3.6% from 2024 to 2031[3].

Q: Which region drives the most demand for diazepam?

North America, particularly the United States, drives a significant portion of the demand due to a high prevalence of anxiety and related disorders[3].

Q: What are the main challenges facing the diazepam market?

The main challenges include regulatory constraints, side effects associated with long-term use, and the emergence of alternative treatments[3].

Q: Who are the key players in the diazepam market?

Key players include Pfizer Inc., Akorn Inc., Hikma, Hameln Pharmaceutical, and Amneal Pharmaceuticals LLC[3].

Q: How is R&D impacting the diazepam market?

Investments in R&D have led to the introduction of novel synthesized benzodiazepines with minimal side effects, which is expected to drive market growth during the medium term[3].

Sources

  1. Fact.MR: Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032
  2. Aquestive Therapeutics: Aquestive Therapeutics Reports First Quarter 2024 Financial
  3. DrugPatentWatch: Generic DIAZEPAM INN entry, drug patent and freedom to operate
  4. BioSpace: Diazepam Market Analysis By Key Players, Share, Size, Trends ...
  5. Aquestive Therapeutics: Aquestive Therapeutics Reports Second Quarter 2024 Financial Results and Provides Business Update

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