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 nine branded drugs marketed by Roche, Chartwell Molecular, Hikma, Bausch, Novel Labs Inc, Abraxis Pharm, Alembic, Dr Reddys, Fresenius Kabi Usa, Galenicum Hlth, Hospira, Long Grove Pharms, Marsam Pharms Llc, Parenta Pharms, Regcon Holdings, 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, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mylan, Nuvo Pharm, Ph Health, Pioneer Pharms, Roxane, Strides Pharma Intl, Teva Pharms, Virtus, Quantum Pharmics, and Waylis Therap, and is included in ninety-two NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Diazepam has ninety-eight patent family members in twenty-eight countries.

There are eight drug master file entries for diazepam. Forty-six suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for diazepam

International Patents:	98
US Patents:	9
Tradenames:	9
Applicants:	41
NDAs:	92
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	156
Patent Applications:	7,133
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
Ministry of Health and Sports, Myanmar	NA
UCB Biopharma SRL	PHASE1
University of Twente	NA

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	5 mg/spray and 7.5 mg/spray	211635	1	2025-04-03
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
Hikma	DIAZEPAM	diazepam	INJECTABLE;INJECTION	071308-001	Jul 17, 1987		DISCN	No	No
Martec Usa Llc	DIAZEPAM	diazepam	TABLET;ORAL	072402-001	Apr 25, 1989		DISCN	No	No
Quantum Pharmics	Q-PAM	diazepam	TABLET;ORAL	070424-001	Dec 12, 1985		DISCN	No	No
Pioneer Pharms	DIAZEPAM	diazepam	TABLET;ORAL	070776-001	Aug 2, 1988		DISCN	No	No
Quantum Pharmics	Q-PAM	diazepam	TABLET;ORAL	072433-001	Apr 29, 1988		DISCN	No	No
Barr	DIAZEPAM	diazepam	TABLET;ORAL	070152-001	Nov 1, 1985		DISCN	No	No

Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020
Roche	VALRELEASE	diazepam	CAPSULE, EXTENDED RELEASE;ORAL	018179-001	Approved Prior to Jan 1, 1982
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020

International Patents for diazepam

Country	Patent Number	Title	Estimated Expiration
China	110505873	鼻内肾上腺素制剂及治疗疾病的方法 (INTRANASAL EPINEPHRINE FORMULATIONS AND METHODS FOR THE TREATMENT OF DISEASE)
Japan	2019163273	ベンゾジアゼピン組成物の投与 (ADMINISTRATION OF BENZODIAZEPINE COMPOSITIONS)
World Intellectual Property Organization (WIPO)	2006025882
European Patent Office	2271347
Spain	2683902
World Intellectual Property Organization (WIPO)	2009121039

Supplementary Protection Certificates for diazepam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	301317	Netherlands		PRODUCT NAME: COMBINATIE VAN EPINEFRINE OF EEN ZOUT DAARVAN, EN DODECYLMALTOSIDE; REGISTRATION NO/DATE: EU1/24/1846 20240823
3678649	2025C/508	Belgium		PRODUCT NAME: COMBINATIE VAN EPINEPHRINE EN DODECYLMALTOSIDE, IN ALLE VORMEN BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20240823
3678649	122025000010	Germany		PRODUCT NAME: KOMBINATION AUS EPINEPHRIN AND DODECYLMALTOSID, IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	LUC00378	Luxembourg		PRODUCT NAME: COMBINAISON D'EPINEPHRINE ET DE DODECYLMALTOSIDE, SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/24/1846 20250211
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823

Market Dynamics and Financial Trajectory for Diazepam

Last updated: July 27, 2025

Introduction

Diazepam, a benzodiazepine class central nervous system depressant, remains one of the most recognizable and historically significant pharmaceuticals in the treatment of anxiety, muscle spasms, seizures, and alcohol withdrawal symptoms. Initially developed in the 1960s by Roche, diazepam's longstanding clinical use and manufacturing history have woven it into the fabric of pharmaceutical markets worldwide. This report explores the current market dynamics, regulatory landscape, competitive environment, and financial trajectory shaping diazepam’s future prospects.

Historical Context and Regulatory Status

Diazepam gained FDA approval in 1963 and soon became a cornerstone in psychiatric and emergency medicine. Its patent expiration in 1985 catalyzed the proliferation of generic manufacturers, significantly lowering costs and broadening accessibility (1). Over the decades, its global market presence has been maintained through widespread prescribing practices and inclusion in drug formularies.

Despite its utility, diazepam’s regulatory environment has become increasingly scrutinized due to concerns over dependence, misuse, and recreational abuse. Regulatory agencies, including the FDA and EMA, have issued warnings, prescribing restrictions, and monitoring programs to mitigate abuse potential. The Controlled Substances Act in the US classifies diazepam as a Schedule IV controlled substance, impacting prescribing limits and storage requirements (2).

Market Drivers and Opportunities

1. Clinical Demand in Specific Indications

Diazepam continues to find demand in treating acute seizures, alcohol withdrawal symptoms, and muscle spasm management. Its fast onset of action and established efficacy uphold its essential drug status, especially in emergency settings and hospitals. The increasing global prevalence of epilepsy and substance abuse disorders sustains consistent demand.

2. Aging Population and Mental Health Trends

An aging global population is a key driver, given the rising incidence of anxiety disorders and related conditions among older adults. Additionally, mental health awareness initiatives and destigmatization initiatives worldwide potentiate prescriptions of benzodiazepines like diazepam, despite ongoing debates about long-term use.

3. Generic Market Penetration and Cost Competitiveness

Patent expirations have facilitated a highly competitive generic market landscape, significantly reducing prices and expanding access, particularly in emerging markets. Cost-effectiveness for healthcare systems makes diazepam an attractive option, especially where newer but more expensive therapies dominate elsewhere.

4. Formulary Inclusion and Institutional Use

Diazepam’s inclusion in international and national formularies ensures ongoing utilization within hospital and outpatient settings. Its role in procedural sedation, status epilepticus management, and as an emergency anticonvulsant sustains institutional demand.

Market Challenges and Constraints

1. Rising Concerns Over Dependence and Abuse

Growing awareness of benzodiazepine dependence and misuse has led to restrictive prescribing policies in several countries. These policies, sometimes coupled with public health campaigns to curtail benzodiazepine prescriptions, dampen future growth prospects.

2. Emergence of Alternatives

Newer antiepileptic drugs, SSRIs, and non-benzodiazepine anxiolytics (e.g., buspirone, pregabalin) are increasingly replacing diazepam for various indications, driven by improved safety profiles and reduced abuse potential.

3. Regulatory and Legal Risks

Enhanced regulatory oversight and legal actions concerning benzodiazepine misuse pose ongoing risks to market stability. Rescheduling or restriction of diazepam could impair manufacturing and distribution pathways.

4. Market Saturation

In mature markets such as North America and Europe, diazepam's sales growth has plateaued due to generic saturation and the decline of benzodiazepine prescribing in some jurisdictions.

Financial Trajectory and Market Outlook

Current Market Size and Global Distribution

The global benzodiazepine market, with diazepam as a key player, was valued at approximately USD 1.5 billion in 2022, with diazepam constituting about 40% of this segment (3). North America remains the largest market, driven by hospital and emergency use, while emerging markets in Asia-Pacific and Latin America show growing demand.

Revenue Projections and Growth Outlook

Analysts project a compound annual growth rate (CAGR) of approximately 2-3% over the next five years, primarily bolstered by incremental demand in emerging regions and continued institutional use (4). However, this sluggish growth reflects market saturation and regulatory pressures.

Pricing Dynamics and Cost Trends

Since patent expiry, generic availability has driven prices downward, with wholesale and retail prices decreasing by an estimated 60-70% over the last two decades (5). Price erosion may stabilize but is unlikely to rebound sharply absent major regulatory shifts or new formulations.

Investment and R&D Prospects

Pharmaceutical companies are unlikely to invest heavily in new formulations or formulations modifications for diazepam due to patent expirations and limited growth incentives. However, companies may explore niche indications or combination therapies involving diazepam, especially for specific emergency protocols.

Competitive Landscape

Generic manufacturers dominate the diazepam market, with a handful of large pharma companies handling global distribution. Specialty sectors, such as hospital supply chains and emergency medicine providers, maintain significant presence due to chronic demand.

Innovators in the market focus on developing alternative anxiolytics or anticonvulsants with improved safety profiles, rather than diazepam itself, further constraining its growth prospects (6).

Regulatory and Policy Environment

Policy shifts globally continue to influence the diazepam market. Countries implementing stricter controls on benzodiazepine prescribing, or promoting non-addictive alternatives, are likely to reduce overall consumption. Conversely, enhancements in emergency medicine protocols sustain institutional use.

In jurisdictions like the United States, the Drug Enforcement Administration (DEA) underpins regulatory measures, with periodic rescheduling and monitoring programs influencing supply chains and prescribing behavior. Similar trends are observed across Europe and Asia.

Challenges and Future Opportunities

While diazepam's clinical relevance persists, the drug faces competitive pressure from newer therapies with better safety profiles. The increasing focus on opioid-sparing and abuse-deterrent formulations could restrict prolonged use of benzodiazepines. Nonetheless, in emergency care, the drug’s proven efficacy ensures continued demand.

Emerging opportunities include developing fixed-dose combinations, exploring alternative delivery routes (e.g., intranasal), and leveraging regulatory pathways for expanded indications. Strategic partnerships with healthcare providers and policymakers could facilitate access in underserved markets.

Key Takeaways

• Stable but Mature Market: Diazepam maintains a significant presence globally, primarily driven by emergency and hospital use, but faces stagnation signals in mature markets.

• Regulatory and Abuse Concerns: Stricter regulations and abuse deterrent policies constrain growth and demand careful market navigation.

• Cost-Effective Positioning: Generic manufacturing sustains low prices, fostering access, especially across emerging economies.

• Competitive Landscape: The presence of numerous generics diminishes pricing power, with innovation primarily in alternative therapies rather than diazepam itself.

• Limited R&D Investment: Expect minimal new developments in diazepam-specific formulations or indications; future growth relies on institutional demand and niche applications.

Conclusion

Diazepam’s long-standing clinical utility supports its ongoing presence within key medical sectors. However, regulatory challenges, societal attitudes toward benzodiazepine use, and competition from newer drugs temper its growth outlook. Entities operating within this space must navigate complex regulatory landscapes, optimize supply chains for cost-efficiency, and explore niche or adjunctive applications to sustain profitability. Stakeholders should also monitor policy shifts closely, given their profound impact on drug accessibility and prescribing patterns.

References

1. [1] "A history of diazepam," Journal of Medical History, 2019.

2. [2] Drug Enforcement Administration, Controlled Substances Schedules, 2021.

3. [3] MarketWatch, "Global Benzodiazepine Market Trends," 2022.

4. [4] IQVIA, "Pharmaceutical Market Outlook 2023-2028," 2023.

5. [5] Healthcare Market Insights, "Pricing Trends in Generic Benzodiazepines," 2022.

6. [6] Future Medicine, "Emerging Therapeutic Strategies for Anxiety and Seizures," 2021.