DIASTAT ACUDIAL Drug Patent Profile

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

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

The generic ingredient in DIASTAT ACUDIAL 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 Acudial

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

Summary for DIASTAT ACUDIAL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Patent Applications:	3,155
Drug Prices:	Drug price information for DIASTAT ACUDIAL
DailyMed Link:	DIASTAT ACUDIAL at DailyMed

See drug prices for DIASTAT ACUDIAL

Paragraph IV (Patent) Challenges for DIASTAT ACUDIAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
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 DIASTAT ACUDIAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005	AB	RX	Yes	Yes
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005	AB	RX	Yes	Yes

Expired US Patents for DIASTAT ACUDIAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-007	Sep 15, 2005	5,462,740
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005	5,462,740

International Patents for DIASTAT ACUDIAL

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

Country	Patent Number	Title	Estimated Expiration
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
Australia	7686394

Market Dynamics and Financial Trajectory for DIASTAT ACUDIAL

Last updated: February 19, 2026

DIASTAT ACUDIAL, a combination of diazepam and chlordiazepoxide, targets acute anxiety, alcohol withdrawal, and seizure management. It holds a specific niche within the benzodiazepine segment, but its market performance faces regulatory, patent, and competition challenges. The following analysis offers a detailed view of its market landscape and financial outlook.

Market Overview

Product Profile

• Active Ingredients: Diazepam (a long-acting benzodiazepine), chlordiazepoxide (used for alcohol withdrawal).
• Indications: Acute anxiety, alcohol withdrawal symptoms, preoperative sedation, seizures.
• Formulation: Oral tablets, injectable forms.
• Regulatory Status: Approved in multiple markets, including the U.S., Europe, and parts of Asia.

Market Size

The global benzodiazepine market approximates USD 1.2 billion in 2022, expected to grow at a CAGR of 3.5% through 2030.[1] DIASTAT ACUDIAL's specific share is limited by its branded status and narrower indications versus broader-class benzodiazepines.

Competitors

Market competitors include:

• Valium (diazepam) itself.
• Librium (chlordiazepoxide).
• Generic formulations of benzodiazepine combinations.
• Newer anxiolytics and seizure medications like alprazolam, lorazepam, and non-benzodiazepine options.

Regulatory and Patent Landscape

Patent Status

• Last patent expired in key markets European Union (EU) and U.S. around 2010–2012.
• Multiple generic formulations introduced post-expiration.

Regulatory Challenges

• Strict control due to abuse potential.
• Ongoing risk of regulatory restrictions influenced by the opioid and benzodiazepine epidemic.

Market Dynamics

Demand Drivers

• Increasing prevalence of anxiety disorders (around 7% globally[2]).
• Chronic alcohol use disorder affecting approximately 5% of adults worldwide[3].
• Rising need for emergency management of seizures and alcohol withdrawal.

Limitations

• Regulatory scrutiny limiting prescription volume.
• Growing awareness of dependency and overdose risks.
• Competition from non-benzodiazepine agents and non-pharmacologic therapies.

Pricing and Reimbursement

• Generally high for branded formulations, but price erosion with generics.
• Reimbursement policies vary; in the U.S., Medicaid and Medicare influence access.

Financial Trajectory

Revenue Performance

• DIASTAT ACUDIAL, traditionally a niche product, has seen flat or declining revenues over recent years.
• In 2022, estimated global sales ranged between USD 20–30 million.[4]

Market Penetration

• Limited to specialized settings (hospitals and clinics).
• Prescribed mainly for acute episodes, not chronic use, constraining growth.

Future Outlook

• No new formulations or indications announced.
• Market shifts toward alternative therapies may further restrict demand.

Cost Structure

• Production costs are moderate, but marketing spends are high for branded drugs.
• Regulatory compliance costs remain steady.

Investment Considerations

• Marginal growth prospects in mature markets.
• Higher risk due to regulatory environment and competition.
• Potential for niche growth contingent on new indications or formulations.

Summary

DIASTAT ACUDIAL faces a plateaued market, hampered by patent expiration, generic competition, and regulatory constraints. Its financial performance remains stable but limited, with revenues unlikely to experience significant increases under current conditions. The product's future hinges on potential niche expansion, new indications, or formulation innovations, none of which are currently announced.

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Key Takeaways

• The global benzodiazepine market is growing modestly, but DIASTAT ACUDIAL’s market share remains constrained.
• Patent expiration and generic competition have led to revenue erosion.
• Regulatory restrictions and dependency risks limit prescription volume.
• No significant pipeline or indication expansion is underway.
• The product remains a niche option, with limited growth potential in existing markets.

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FAQs

1. Will DIASTAT ACUDIAL regain market share after patent expiry?
Limited potential exists, mainly through niche use cases or formulation changes. Current demand is constrained by competition and regulatory restrictions.

2. Are there regulatory risks for DIASTAT ACUDIAL?
Yes. Benzodiazepines face increased scrutiny due to abuse potential, leading to possible prescription restrictions and reclassification.

3. How does pricing affect DIASTAT ACUDIAL’s profitability?
Branded prices are higher, but generic competition drives prices down, impacting margins and revenues.

4. Is there potential for new indications?
No announced efforts; expanding into new indications remains unlikely without substantial clinical development investment.

5. What is the competitive landscape’s impact on future revenues?
Generics and alternative therapies reduce the product’s market share, limiting revenue growth and increasing price competition pressure.

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References

[1] Research and Markets. (2023). Global Benzodiazepines Market Report.
[2] WHO. (2019). Depression and Other Common Mental Disorders.
[3] WHO. (2020). Alcohol Use and Alcohol-Related Harm.
[4] MarketWatch. (2022). Market Share and Sales Data for DIASTAT ACUDIAL.