Diazepam - Generic Drug Details

What are the generic drug sources for diazepam and what is the scope of freedom to operate?

Diazepam is the generic ingredient in ten branded drugs marketed by Roche, Chartwell Molecular, Hikma, Aquestive, Bausch, Novel Labs Inc, Abraxis Pharm, Alembic, Beloteca, Dr Reddys, Fresenius Kabi Usa, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Pharmacia And Upjohn, Neurelis Inc, Actavis Elizabeth, Aurobindo Pharma Ltd, Barr, Chartwell Rx, Dr Reddys Labs Sa, Duramed Pharms Barr, Endo Operations, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Pioneer Pharms, Roxane, Strides Pharma, Teva Pharms, Virtus, Quantum Pharmics, and Waylis Therap, and is included in ninety-one NDAs. There are seven patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has one hundred and eighteen patent family members in twenty-eight countries.

There are eight drug master file entries for diazepam. Forty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for diazepam

International Patents:	118
US Patents:	7
Tradenames:	10
Applicants:	40
NDAs:	91
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	142
Patent Applications:	6,517
Drug Prices:	Drug price trends for diazepam
Drug Sales Revenues:	Drug sales revenues for diazepam
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diazepam
What excipients (inactive ingredients) are in diazepam?	diazepam excipients list
DailyMed Link:	diazepam at DailyMed

See drug prices for diazepam

See drug sales revenues for diazepam

Recent Clinical Trials for diazepam

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

Sponsor	Phase
University of Jordan	Phase 3
Assiut University	N/A
Walter Reed National Military Medical Center	Phase 2

See all diazepam clinical trials

Generic filers with tentative approvals for DIAZEPAM

Applicant	Application No.	Strength	Dosage Form
		20MG	FILM;BUCCAL
		17.5MG	FILM;BUCCAL
		15MG	FILM;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for diazepam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for diazepam

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Muscle Relaxants, Central

Anatomical Therapeutic Chemical (ATC) Classes for diazepam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DIAZEPAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VALTOCO	Nasal Spray	diazepam	10 mg/spray	211635	1	2024-02-14
DIASTAT ACUDIAL	Rectal Gel	diazepam	5 mg/mL, 2mL pre-filled syringe	020648	1	2008-12-23
DIASTAT ACUDIAL	Rectal Gel	diazepam	5 mg/mL, 4mL pre- filled syringe	020648	1	2008-12-08
DIASTAT ACUDIAL	Rectal Gel	diazepam	2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 15 mg/3 mL 20 mg/4 mL	020648	1	2004-03-23

US Patents and Regulatory Information for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Virtus	DIAZEPAM	diazepam	TABLET;ORAL	070462-001	Feb 25, 1986		DISCN	No	No
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-002	Jul 29, 1997		DISCN	Yes	No
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No

Expired US Patents for diazepam

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
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997
Pharmacia And Upjohn	DIZAC	diazepam	INJECTABLE;INJECTION	019287-001	Jun 18, 1993

International Patents for diazepam

Country	Patent Number	Title	Estimated Expiration
Japan	6523397
Canada	3088989	FORMULATIONS D'EPINEPHRINE INTRANASALE ET METHODES DE TRAITEMENT D'UNE MALADIE (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
European Patent Office	3452024	COMPOSITIONS PHARMACEUTIQUES À PERMÉATION AMÉLIORÉE (PHARMACEUTICAL COMPOSITIONS WITH ENHANCED PERMEATION)

Diazepam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diazepam

Introduction to Diazepam

Diazepam, a benzodiazepine, is widely used for treating anxiety, insomnia, alcohol withdrawal symptoms, and seizures. The market for diazepam is influenced by several key factors, including healthcare access, regulatory environments, and the prevalence of mental health disorders.

Market Size and Forecast

The diazepam market has been experiencing steady growth. As of 2023, the market size was valued at USD 1.28 billion and is projected 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[1][3][4].

Geographic Segmentation

The diazepam market is segmented geographically into several key regions:

North America

North America, particularly the United States, drives a significant portion of the demand due to a high prevalence of anxiety and related disorders, supported by a well-established healthcare infrastructure and the availability of prescription medications. This region held the largest share of 38.3% in the diazepam industry in 2018[1][4].

Europe

Europe, with countries like Germany and France, also shows a strong demand for diazepam due to robust pharmaceutical sectors and high healthcare spending[1].

Asia-Pacific

The Asia-Pacific region, especially countries like India and China, is witnessing significant growth driven by increasing awareness of mental health and rising disposable incomes. This region is expected to remain the highest growing segment, with a CAGR of 3.8% during the forecast period[1][4].

Latin America and Middle East & Africa

Latin America presents a mixed picture due to urbanization and access to healthcare, but economic instability can hinder market growth. The Middle East & Africa represents a nascent but emerging segment, driven by growing healthcare investments and efforts to combat mental health issues[1].

Drivers of Market Growth

Several factors drive the growth of the diazepam market:

Improved Access to Healthcare

Increased access to healthcare services, particularly in developing regions, boosts the use of diazepam[1].

Public Awareness and Education

Increased awareness of mental health issues and the effectiveness of benzodiazepines like diazepam lead to higher demand for these medications[1].

Drug Pricing and Insurance Coverage

The affordability of diazepam and its coverage by insurance plans significantly influence its market penetration and overall demand[1].

Rising Cases of Mental Disorders

The increasing cases of anxiety-related disorders globally drive the demand for benzodiazepine drugs, including diazepam. Urbanization and the current work culture have significantly increased mental health problems, creating a huge growth opportunity for manufacturers[2].

Challenges and Restraints

Despite the growth, the diazepam market faces several challenges:

Regulatory and Legislative Factors

Stringent guidelines regarding endorsements and the need to limit monthly benzodiazepine use can affect market dynamics. Regulatory measures to control the negative side effects of long-term benzodiazepine use are being considered[1][5].

Side Effects and Dependence

Long-term use of benzodiazepines is associated with side effects such as memory loss, Alzheimer's disease, dependence, addiction, and increased risk of falls and traffic accidents. These factors can limit the market growth[5].

Alternative Treatments

Shifts towards non-benzodiazepine treatments and the presence of generic versions of diazepam can affect market share and pricing[1].

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[3][4].

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[4].

Financial Trajectory

The financial trajectory of the diazepam market is marked by steady growth:

• 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[1].
• 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[5].

Key Players and Market Competition

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

• Pfizer Inc., Akorn Inc., Hikma, Hameln Pharmaceutical, and Amneal Pharmaceuticals LLC are some of the major companies operating in the benzodiazepine drugs market, including diazepam[2].

Technological Advancements and R&D

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)[2].

Conclusion

The diazepam market is poised for significant growth driven by increasing awareness of mental health, improved access to healthcare, and the rising prevalence of anxiety-related disorders. However, it faces challenges such as regulatory constraints, side effects, and the emergence of alternative treatments.

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)

1. What is the projected market size of diazepam by 2031?

The diazepam market is projected to reach USD 1.51 billion by 2031[1].

2. Which region is expected to show the highest growth in the diazepam market?

The Asia-Pacific region is expected to remain the highest growing segment, with a CAGR of 3.8% during the forecast period[4].

3. What are the main drivers of the diazepam market?

Improved access to healthcare, public awareness of mental health issues, and the affordability of diazepam are main drivers[1].

4. What are the significant challenges facing the diazepam market?

Regulatory constraints, side effects associated with long-term use, and the emergence of alternative treatments are significant challenges[1][5].

5. Which companies are major players in the diazepam market?

Companies such as Pfizer Inc., Akorn Inc., Hikma, and Amneal Pharmaceuticals LLC are major players in the benzodiazepine drugs market, including diazepam[2].

Cited Sources:

1. Verified Market Research - Diazepam Market Size, Share, Trends & Forecast[1]
2. Fact.MR - Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032[2]
3. Market Research Intellect - Global Diazepam Market Size And Forecast[3]
4. Reports and Data - Diazepam Market Share, Trends, Growth | Analysis, 2020-2027[4]
5. PubMed - Evolving Trends and Economic Burden of Benzodiazepine Use[5]