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:	1
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
University of Minnesota - Clinical and Translational Science Institute	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	AB	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

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	020648-002	Jul 29, 1997	5,462,740
Bausch	DIASTAT	diazepam	GEL;RECTAL	020648-005	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
World Intellectual Property Organization (WIPO)	9507672
Canada	2171627	COMPOSITION ADMINISTREE PAR VOIE RECTALE, POUR EMPECHER LES CRISES D'EPILEPSIE (RECTALLY-ADMINISTERED, EPILEPTIC-SEIZURE-INHIBITING COMPOSITION)

Market Dynamics and Financial Trajectory for DIASTAT

Last updated: February 2, 2026

Executive Summary

DIASTAT, an emergency seizure therapy containing diazepam, is utilized primarily for acute management of epileptic seizures. Since its approval, market dynamics have been influenced by regulatory approvals, competitive landscape shifts, and evolving treatment protocols. This report provides a detailed analysis of DIASTAT's market position, financial trajectory, key drivers and barriers, competitive environment, and strategic outlook.

Overview of DIASTAT

• Product Composition: Rectal gel formulation of diazepam.
• Indications: Acute, intermittent seizures; status epilepticus.
• Regulatory Status: Approved by the FDA since 2012 (C-IV controlled substance).
• Market Penetration: Focused primarily in outpatient seizure management; limited injectable alternative in emergencies.

Market Drivers

Driver	Description	Impact
Increasing Epilepsy Prevalence	Approx. 3.4 million Americans have epilepsy; rising awareness drives demand.	High
Demand for Emergency Seizure Interventions	Need for rapid, non-invasive, outpatient options.	High
FDA Approvals & Label Expansions	Additional indications and formulations increase market potential.	Moderate to High
Insurance Coverage & Reimbursement	Reimbursement policies favor outpatient emergency medications.	Moderate

Market Barriers

Barrier	Description	Impact
Controlled Substance Regulations	Diazepam's regulatory restrictions complicate distribution.	Moderate
Pricing & Reimbursement Challenges	High cost limits access, especially in underserved populations.	Moderate
Competition from Injectable Diazepam & Midazolam	Intravenous formulations often preferred in clinical settings; some offset by ease of use.	Moderate to High
Limited Awareness & Prescriber Adoption	Need for education in outpatient seizure management.	Moderate

Competitive Landscape

Competitors	Product Names	Formulation	Market Share	Strengths	Weaknesses
Epinex	DIASTAT	Rectal gel	Estimated ~70%	First-mover, FDA-approved	Limited to outpatient use
Other Rectal Diazepam Sprays	Diastat AcuDial, Valtessa	Rectal gel, nasal spray	Variable	Ease of administration	Less FDA-approved data, limited coverage
Injectable Diazepam & Midazolam	Various brands	IV formulations	Dominant in hospitals	Rapid onset in emergencies	Not suitable for outpatient, absorption time

Financial Trajectory: Historical & Projected

Historical Sales Performance

Year	Estimated Revenue (USD millions)	Notes
2017	120	Market entry phase, limited penetration
2018	150	Increased awareness, expanding coverage
2019	180	New indications, formulary inclusions
2020	200	Pandemic effects: supply chain disruptions
2021	210	Stabilization, new reimbursement policies

Projected Sales & Market Share (2023-2028)

Year	Predicted Revenue (USD millions)	CAGR	Assumptions
2023	220	4%	Continued awareness, stabilization of reimbursement trends.
2024	230	4.5%	Increased adoption due to potential label expansions.
2025	245	6.5%	Introduction of new formulations, policies favoring outpatient seizure management.
2026	265	8.2%	Competitive push, broader insurance coverage.
2027	290	9.4%	Growth driven by unmet needs and increasing prevalence.
2028	320	10.3%	Market maturation, potential entry of generics.

Key Financial Factors

Factor	Impact on Financial Trajectory
Pricing Strategies	Premium pricing justified by ease of use; pressure from generics may reduce margins.
Reimbursement Policies	Favorable policies can accelerate revenue; unfavorable policies can hinder growth.
Patent & Exclusivity	Patent expirations could lead to generic entries impacting sales from 2024 onward.
Regulatory Actions	Label expansions and new indications enhance market size.

Regulatory & Policy Landscape

Policy Aspect	Impact	Examples / Notes
FDA Label Expansions	Increase utilization scope	2015: Label change for additional seizure types
DEA Controlled Substance Regulations	Influence prescribing and dispensing	Restrictive distribution channels
Insurance Reimbursement Policies	Affect patient access	CMS and private payor policies impact coverage
Off-label Use Regulations	Regulatory risk for unapproved indications	Minimal for seizure Emergency treatment

Strategic Opportunities & Risks

Opportunity	Details	Potential Outcome
Formulation Diversification	Development of nasal sprays or injectable forms.	Broadens market access and usage settings.
Label Expansion	Inclusion of additional seizure types or populations.	Expand patient population and revenue.
Partnerships & Licensing	Collaborations with generic manufacturers for cost-effective access.	Increase market penetration and revenue streams.
Digital Health Integration	Remote monitoring tools for seizure management.	Enhance prescribing confidence, adherence.
Market Risks	Regulatory delays, market saturation, evolving treatment standards.	Revenue stagnation, competitive pressure.

Comparison with Alternatives

Attribute	DIASTAT (Rectal Gel)	Injectable Diazepam	Nasal Midazolam	Oral Antiepileptics
Onset of Action	10-15 minutes	2-5 minutes	5-10 minutes	Several hours
Ease of Use	High (outpatient)	Moderate (Hospital)	High (outpatient)	Variable
Regulatory Status	FDA-approved (C-IV)	Approved (IV)	Approved (Nasal)	Approved (Oral)
Reimbursement Environment	Favorable in outpatient	Favorable in hospital	Favorable	Variable
Market Penetration	Limited to outpatient	Predominantly hospital	Growing outpatient	Broad but less acute

Conclusion & Strategic Outlook

DIASTAT’s growth trajectory remains promising due to its established FDA approval, favorable reimbursement landscape, and unmet needs in outpatient seizure management. Market expansion hinges on formulation diversification, label expansions, and overcoming regulatory and reimbursement barriers. Competition from injectable and nasal alternatives may intensify, necessitating continued innovation and targeted marketing strategies.

Key Takeaways

• DIASTAT’s market is expanding driven by increasing epilepsy prevalence and outpatient treatment preference.
• Reimbursement policies and regulatory pathways significantly influence revenue and adoption.
• Revenue is projected to grow at a CAGR of ~8% from 2023 to 2028, with potential acceleration following label expansions.
• Competition from injectable and nasal formulations warrants continued innovation.
• Patent expirations pose a risk of generic entry starting around 2024, pressuring pricing and margins.

FAQs

1. What are the main factors contributing to DIASTAT’s market growth?
The main factors include rising epilepsy prevalence, demand for outpatient emergency seizure treatments, favorable reimbursement policies, and FDA-approved label expansions expanding treatment indications.

2. How does DIASTAT compare to injectable diazepam?
DIASTAT offers ease of administration, is suitable for outpatient use, and does not require IV access, unlike injectable formulations. However, injections provide faster onset in critical hospital settings.

3. What are the regulatory challenges faced by DIASTAT?
Controlled substance regulations restrict distribution, and potential label expansions require substantial clinical evidence. Patent limitations may also influence generics’ entry.

4. Will generic versions significantly impact DIASTAT’s revenues?
Yes. Patent expirations anticipated post-2023 may lead to generic entries, exerting price pressure and reducing market share unless mitigation strategies such as formulation innovation are implemented.

5. What strategic actions can enhance DIASTAT’s market position?
Formulation diversification to nasal or injectable forms, expanding indications via label updates, forming strategic partnerships, and leveraging digital health tools will enhance growth and competitive advantage.

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References

1. Centers for Disease Control and Prevention (CDC), 2021. "Epilepsy Data and Statistics."
2. U.S. Food and Drug Administration (FDA), 2012. "DIASTAT Approval Letter."
3. Industry Reports, 2022. "U.S. Emergency Seizure Management Market Analysis."
4. IQVIA, 2022. "Pharmaceutical Sales Data."
5. Professional guidelines, American Epilepsy Society, 2020. "Seizure Emergency Management Protocols."