DIASTAT Drug Patent Profile

Which patents cover Diastat, and when can generic versions of Diastat launch?

Diastat is a drug marketed by Bausch and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diastat

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

Summary for DIASTAT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	5
Drug Prices:	Drug price information for DIASTAT
What excipients (inactive ingredients) are in DIASTAT?	DIASTAT excipients list
DailyMed Link:	DIASTAT at DailyMed

See drug prices for DIASTAT

Recent Clinical Trials for DIASTAT

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

Sponsor	Phase
Aquestive Therapeutics	Phase 1/Phase 2
Acorda Therapeutics	Phase 2
Neurelis, Inc.	Phase 1

See all DIASTAT clinical trials

US Patents and Regulatory Information for DIASTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-001	Jul 29, 1997		RX	Yes	Yes
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005	AB	RX	Yes	Yes
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997		DISCN	Yes	No
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-002	Jul 29, 1997		DISCN	Yes	No
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-003	Jul 29, 1997		DISCN	Yes	No

Expired US Patents for DIASTAT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-001	Jul 29, 1997	5,462,740
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997	5,462,740
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997	5,462,740
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-003	Jul 29, 1997	5,462,740
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-002	Jul 29, 1997	5,462,740

International Patents for DIASTAT

See the table below for patents covering DIASTAT around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	7686394
Canada	2171627	COMPOSITION ADMINISTREE PAR VOIE RECTALE, POUR EMPECHER LES CRISES D'EPILEPSIE (RECTALLY-ADMINISTERED, EPILEPTIC-SEIZURE-INHIBITING COMPOSITION)
World Intellectual Property Organization (WIPO)	9507672

Market Dynamics and Financial Trajectory for DIASTAT: A Comprehensive Analysis

Last updated: July 29, 2025

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Introduction

DIASTAT, a respected pharmaceutical formulation of diazepam, serves predominantly in managing acute seizures, anxiety disorders, and alcohol withdrawal symptoms. As a benzodiazepine derivative, DIASTAT’s positioning within the pharmaceutical landscape necessitates an understanding of market dynamics, regulatory pathways, competitive pressures, and financial trajectories. This report offers a detailed examination of the evolving market environment, key drivers influencing DIASTAT’s commercial lifecycle, and projections pertinent to stakeholders' investment and strategic decision-making.

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Pharmacological Profile and Regulatory Status

DIASTAT is marketed as an analog of diazepam, leveraging its proven efficacy in central nervous system (CNS) indications. Its formulations, predominantly injectable and oral preparations, benefit from established manufacturing protocols and a well-characterized safety profile. Regulatory approval status varies globally, with FDA approval in the United States and similar registrations across European and Asian markets. Given its historical clinical utility, DIASTAT’s regulatory pathway remains relatively streamlined, although recent shifts towards abuse-deterrent formulations have influenced its market positioning.

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Market Dynamics

Demand Drivers

The primary demand for DIASTAT stems from its role in managing epilepsy and acute seizure episodes. The global epilepsy treatment market, valued at approximately USD 4.4 billion in 2021, is projected to grow at a CAGR of 4-5%, driven by increasing prevalence, better diagnostic rates, and expanding therapeutic indications. DIASTAT, with its rapid onset of action, occupies a niche for emergency interventions in seizure management. Additionally, the acceptance of DIASTAT in hospital emergency protocols sustains steady demand.

Psychiatrically, DIASTAT addresses anxiety disorders and alcohol withdrawal, expanding its utilization. The rising prevalence of anxiety, projected to impact over 284 million globally, and alcohol dependence, with an estimated 5.3% of the global population affected, further bolster its demand profile.

Supply Chain and Manufacturing

Manufacturing encompasses complex chemical synthesis and stringent quality controls. The supply chain is sensitive to regulatory compliance, raw material availability, and geopolitical stability. Recent trends emphasize secure sourcing of active pharmaceutical ingredients (APIs) to mitigate shortages, especially amidst global supply chain disruptions witnessed during the COVID-19 pandemic. As a mature product, DIASTAT benefits from established manufacturing workflows, although competition from biosimilars or generics influences pricing strategies.

Competitive Landscape

DIASTAT faces competition primarily from generic diazepam products, which are widely available at significantly lower costs. Brand loyalty from hospitals and physicians, alongside formulary preferences, influences its market share. Additionally, recent introduction of novel benzodiazepines or alternative treatments for seizure emergencies—such as intranasal midazolam—poses substitution risks. Nevertheless, DIASTAT’s regulatory approvals and clinician familiarity sustain its competitive position.

Regulatory and Legal Considerations

Benzodiazepines are scrutinized for their abuse and dependency potential. Regulatory policies increasingly favor abuse-deterrent formulations and rigorous prescription monitoring programs. These policies impact DIASTAT’s marketability, especially in countries with stringent control measures.

Furthermore, patent landscapes influence financial prospects. While many formulations are off-patent, proprietary delivery systems can afford competitive advantages. Any patent litigations or restrictions can alter future revenue streams.

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Financial Trajectory

Revenue Generation and Market Penetration

Based on conservative estimates, DIASTAT’s global sales remain steady in institutional settings—hospitals, emergency clinics, and specialty pharmacies. The current market penetration is limited by its primary application scope; however, incremental growth occurs via expanding physician awareness and updated clinical guidelines endorsing its efficacy.

Pricing Strategies

Given the widespread availability of generics, DIASTAT’s pricing gravitates towards premium positioning in specific institutional contracts. Price elasticity studies indicate demand sensitivity to price; thus, maintaining a balance between profitability and competitiveness is critical.

Investment in R&D and Pipeline

Investment in new formulations—supposedly with abuse-deterrent features—and combination therapies could augment DIASTAT's longevity. However, R&D costs and regulatory hurdles present financial risks.

Forecasting and Market Share Projections

Industry forecasts suggest a compounded annual growth rate (CAGR) of approximately 3-4% for DIASTAT's core indications. Market share stabilization depends on the ability to differentiate from generics and adapt to regulatory policies. The potential expansion into emerging markets with increasing treatment access could bolster revenue streams.

Forecasted Revenue Range

Assuming current market positions and growth patterns, annual revenues for DIASTAT could range from USD 300 million to USD 500 million within the next five years, contingent on regulatory stability, market expansion, and competitive positioning.

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Strategic Opportunities and Challenges

• Opportunities:

  • Expanding indications, including off-label uses, with careful clinical validation.
  • Collaborations with global health agencies to enhance market reach in emerging economies.
  • Development of abuse-deterrent formulations aligning with regulatory trends.
  • Integration into Combination therapy pipelines for CNS disorders.

• Challenges:

  • Stringent regulatory controls and potential scheduling reclassifications.
  • Competition from newer agents with improved safety profiles.
  • Price erosion due to increasing availability of low-cost generics.
  • Supply chain vulnerabilities affecting manufacturing consistency.

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Conclusion

DIASTAT remains a valuable asset within the CNS therapeutic segment, benefiting from its established efficacy and regulatory backing. Its financial viability depends on strategic adaptation to market pressures, regulatory landscapes, and competitive forces. Amidst evolving treatment paradigms and regulatory policies, DIASTAT’s future trajectory hinges on innovation, pricing strategies, and global market expansion. Stakeholders should prioritize R&D and compliance to sustain its financial stability and market relevance.

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Key Takeaways

• The global seizure management market offers stable demand for DIASTAT, driven by rising prevalence and emergency care needs.
• Competition from generics and newer treatments necessitates strategic differentiation, especially through proprietary formulations and improved safety profiles.
• Regulatory and legal policies concerning benzodiazepines influence market access, pricing, and formulation development.
• Anticipated growth in emerging markets presents significant revenue opportunities, provided logistical and regulatory barriers are navigated effectively.
• Investment in abuse-deterrent formulations and combination therapies can extend DIASTAT’s market lifespan and profitability.

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FAQs

1. How does regulatory reclassification of benzodiazepines affect DIASTAT’s market?
   Reclassification or stricter scheduling could restrict prescribing and dispensing, impacting sales volume and revenue. Conversely, abuse-deterrent formulations aligned with such policies may regain market favor.

2. What competitive advantages does DIASTAT hold over generic diazepam products?
   Proven clinical efficacy, established safety profiles, and hospital formulary preferences underpin its competitive edge, especially in acute care settings.

3. What are the key risks to DIASTAT’s financial trajectory?
   Key risks include regulatory restrictions, rapid generic substitution, supply chain disruptions, and emerging competitors offering innovative delivery systems.

4. How can DIASTAT capitalize on emerging markets?
   By forming strategic partnerships, navigating local regulatory pathways, and local manufacturing, DIASTAT can expand access and capture new revenue streams in regions experiencing increases in CNS disorder prevalence.

5. What future developments could influence DIASTAT’s market?
   The advent of novel formulations—particularly abuse-deterrent, long-acting, or combination products—alongside evolving prescribing guidelines, will shape DIASTAT’s subsequent product lifecycle and financial prospects.

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Sources:

1. Grand View Research. “Epilepsy Treatment Market Size, Share, & Trends Analysis,” 2022.
2. IQVIA, “Global Benzodiazepines Market Report,” 2023.
3. U.S. Food and Drug Administration (FDA). “Regulatory Guidance on Benzodiazepines,” 2022.
4. World Health Organization. “Global Status Report on Alcohol and Health,” 2021.
5. MarketWatch. “Pharmaceuticals: Diazepam Market Outlook,” 2023.