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, Beloteca, Dr Reddys, Fresenius Kabi Usa, Galenicum Hlth, Hospira, Long Grove Pharms, 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-two 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 ninety-eight patent family members in twenty-eight countries.

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

Summary for diazepam

International Patents:	98
US Patents:	7
Tradenames:	9
Applicants:	41
NDAs:	92
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	142
Patent Applications:	5,473
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	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
Strides Pharma	DIAZEPAM	diazepam	TABLET;ORAL	077749-001	Mar 31, 2006	AB	RX	No	No
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020		RX	Yes	No

Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-001	Jan 10, 2020	9,642,913
Neurelis Inc	VALTOCO	diazepam	SPRAY;NASAL	211635-002	Jan 10, 2020	9,642,913
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997	5,462,740

International Patents for diazepam

Country	Patent Number	Title	Estimated Expiration
China	116549389	鼻内肾上腺素制剂及治疗疾病的方法 (Intranasal epinephrine formulations and methods of treating diseases)
Japan	2014519525
World Intellectual Property Organization (WIPO)	2009121039

Supplementary Protection Certificates for diazepam

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3678649	PA2025507	Lithuania		PRODUCT NAME: VISU FORMU EPINEFRINO IR DODECILMALTOZIDO DERINYS SAUGOMASPAGRINDINIO PATENTO; REGISTRATION NO/DATE: EU/1/24/1846 20240822
3678649	CA 2025 00007	Denmark		PRODUCT NAME: KOMBINATION AF EPINEPHRIN ELLER ET SALT DERAF, OG DODECYLMATOSID; REG. NO/DATE: EU/1/24/1846 20240823
3678649	C20250011	Finland

Market Dynamics and Financial Trajectory of Diazepam

Last updated: July 3, 2025

Introduction

Diazepam, a cornerstone benzodiazepine since its approval in the 1960s, continues to shape the pharmaceutical landscape as a treatment for anxiety, seizures, and muscle spasms. As a generic drug, it exemplifies how mature medications navigate evolving market forces and financial pressures. This analysis delves into Diazepam's market dynamics—covering demand trends, competition, and regulations—and its financial trajectory, including revenue patterns and future outlook. For business professionals, understanding these elements is crucial for investment decisions in a sector influenced by patent expirations and generic proliferation.

Current Market Overview

The global market for Diazepam remains robust, driven by persistent demand for mental health treatments. In 2023, the benzodiazepine market, which includes Diazepam, reached an estimated value of $4.5 billion, with Diazepam accounting for a significant portion due to its widespread use. According to industry data, annual sales volumes exceed 10 million prescriptions in the U.S. alone, reflecting its role in addressing rising anxiety disorders amid post-pandemic mental health challenges.

Key players in Diazepam's supply chain include generic manufacturers like Teva Pharmaceuticals and Mylan, which dominate production following the expiration of original patents. These companies leverage cost-effective manufacturing to maintain market share, while emerging players in Asia, such as Dr. Reddy's Laboratories, expand through affordable exports. The market's fragmentation underscores a shift from branded dominance to generic efficiency, with prices stabilizing at around $0.10–$0.50 per tablet in major markets.

Key Market Dynamics

Demand Drivers

Diazepam's demand stems from its efficacy in treating acute conditions, fueling steady consumption worldwide. In the U.S. and Europe, increasing diagnoses of generalized anxiety disorder—now affecting over 40 million adults annually—propel usage. Data from the World Health Organization indicates that benzodiazepine prescriptions, including Diazepam, rose by 15% between 2019 and 2023, driven by telemedicine and mental health initiatives.

However, external factors like the opioid crisis temper growth. Regulatory bodies, such as the FDA, have issued guidelines cautioning against long-term use due to addiction risks, potentially capping demand at 2–3% annual growth. Conversely, aging populations in developed nations boost needs for Diazepam in managing age-related seizures, creating a counterbalance that sustains market stability.

Competitive Landscape

Competition in the Diazepam market is intense, characterized by low barriers to entry for generics. Major competitors include Pfizer and Sandoz, which offer formulations at competitive prices, while Indian firms like Sun Pharma challenge with cost advantages. This saturation keeps profit margins slim, with generic versions capturing over 90% of market share since the original patent expired in the 1980s.

Innovation plays a limited role here, as Diazepam's formula is well-established. Companies differentiate through extended-release versions or combination therapies, such as Diazepam with antidepressants, to carve out niches. Yet, price wars persist, with average selling prices dropping 5% yearly in key markets like the UK and Germany, according to IQVIA reports.

Regulatory Environment

Regulatory scrutiny defines Diazepam's market dynamics, with agencies like the European Medicines Agency (EMA) and FDA enforcing strict controls. Recent updates, including the FDA's 2022 black box warning on benzodiazepine risks, have influenced prescribing patterns and import regulations. In emerging markets, such as Brazil and India, local authorities impose price caps to enhance accessibility, impacting global supply chains.

Patents no longer shield Diazepam, but intellectual property around new delivery methods—such as injectable forms—offers temporary advantages. For instance, a 2021 EMA approval for a novel Diazepam nasal spray by Neurelis highlights how regulatory pathways can refresh market interest, albeit in specialized segments.

Financial Trajectory

Historical Revenue Trends

Diazepam's financial history reflects a classic generic lifecycle. Peak revenues for branded versions, originally held by Roche, hit $500 million annually in the 1970s. Post-patent expiration, revenues plummeted as generics flooded the market, reducing global sales to around $1.2 billion by 2023 for Diazepam alone.

In the U.S., Medicare and Medicaid reimbursements have stabilized revenues for manufacturers, with annual figures hovering at $300–400 million. Historical data from Statista shows a compound annual growth rate (CAGR) of -2% over the past decade, driven by price erosion rather than volume declines.

Current Financial Performance

Today, Diazepam generates modest profits for producers, with gross margins averaging 30–40% due to low production costs. Teva Pharmaceuticals, for example, reported Diazepam-related revenues of approximately $150 million in its 2023 fiscal year, bolstered by efficient supply chains. However, inflationary pressures on raw materials have squeezed net profits, leading to a 10% dip in earnings for some players.

Financial metrics reveal resilience: return on investment (ROI) for generic Diazepam lines exceeds 15% for leading firms, supported by high-volume sales in retail pharmacies. Yet, currency fluctuations in export-dependent markets like China add volatility, as evidenced by a 5% revenue drop for Asian manufacturers in 2023.

Future Projections

Looking ahead, Diazepam's financial trajectory points to gradual decline, with projections from Grand View Research estimating a market contraction to $1 billion by 2030. Factors like patent cliffs for related drugs and growing adoption of alternatives—such as SSRIs for anxiety—will erode shares.

Opportunities exist in emerging markets, where demand could grow at 4% CAGR through 2028, driven by urbanization and healthcare expansion. Strategic moves, like partnerships for biosimilar developments, might mitigate risks. Overall, investors should anticipate single-digit returns, with potential upticks if regulatory reforms ease distribution.

Challenges and Opportunities

Diazepam faces challenges from addiction concerns and generic oversupply, which could reduce demand by 20% in the next five years. Supply chain disruptions, highlighted by the 2022 global shortages, further complicate finances for manufacturers.

On the flip side, opportunities arise from mental health reforms and digital health integrations. Companies innovating with AI-driven prescribing tools or sustainable packaging could differentiate, potentially boosting margins. For business leaders, this landscape demands agile strategies to capitalize on niche growth areas.

Conclusion and Key Takeaways

In summary, Diazepam's market dynamics and financial trajectory underscore the realities of a mature pharmaceutical asset: steady demand amid regulatory hurdles and financial pressures from generics. Business professionals can leverage this insight to navigate investments in mental health sectors, balancing risks with emerging opportunities.

Key Takeaways

• Diazepam's market remains stable at $1.2 billion globally, driven by mental health needs but constrained by regulations.
• Financial performance shows declining revenues due to price competition, with projections indicating further contraction by 2030.
• Opportunities in innovative formulations and emerging markets could offset challenges for proactive manufacturers.
• Regulatory factors, like FDA warnings, play a pivotal role in shaping demand and profitability.
• Investors should monitor generic competition and alternative therapies to inform strategic decisions.

Frequently Asked Questions

1. What factors are driving the current demand for Diazepam? Demand is primarily fueled by rising anxiety diagnoses and its use in acute care, though regulatory warnings on addiction risks are moderating growth.
2. How has the expiration of Diazepam's patents affected its financials? Patent expiration led to a surge in generics, causing revenue declines and thinner margins for original manufacturers since the 1980s.
3. What competition does Diazepam face in the market? It competes with other benzodiazepines and non-addictive alternatives like SSRIs, with generic producers dominating through price advantages.
4. Are there any upcoming regulatory changes that could impact Diazepam's trajectory? Potential FDA reforms on benzodiazepine prescribing could limit long-term use, affecting market volumes in the U.S. and Europe.
5. How might global economic shifts influence Diazepam's future finances? Inflation and supply chain issues could raise costs, but expanding healthcare in developing regions may create new revenue streams.

Sources

1. World Health Organization. "Mental Health and Substance Use Disorders," WHO Global Report, 2023.
2. IQVIA Institute. "Global Use of Medicines," IQVIA Report, 2023.
3. Statista. "Benzodiazepine Market Size and Forecast," Statista Database, 2023.
4. Grand View Research. "Benzodiazepines Market Analysis," Grand View Research Report, 2023.