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-nine 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:	2
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	5,683
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
Bausch	DIASTAT ACUDIAL	diazepam	GEL;RECTAL	020648-006	Sep 15, 2005

International Patents for DIASTAT ACUDIAL

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

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

DIASTAT ACUDIAL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diastat AcuDial

Introduction to Diastat AcuDial

Diastat AcuDial, a brand-name prescription medication, is a gel formulation of diazepam designed for rectal administration. It is specifically used to manage selected, refractory seizure patterns in adults and children aged 2 years and older with epilepsy[4].

Market Overview

Global Diazepam Market

The global diazepam market, which includes Diastat AcuDial, was valued at USD 1.01 billion in 2019 and is projected to reach USD 1.31 billion by 2027, growing at a Compound Annual Growth Rate (CAGR) of 3.4%. Key drivers include the rising incidence of anxiety disorders, insomnia, and alcohol addiction, along with increasing investments in research and development and new product launches[3].

Segmentation and Growth

The rectal gel type segment, which includes Diastat AcuDial, is expected to grow with a CAGR of 3.3% during the forecast period. While tablets remain the chief revenue-generating segment, the rectal gel form is gaining traction due to its specific use in treating seizure clusters[3].

Geographical Performance

North America

North America is the key revenue-generating geographical segment for the diazepam market, including Diastat AcuDial. This region accounted for USD 376.4 million in 2018. Factors such as availability of research funds, awareness about mental disorders, state-of-the-art medications, and favorable reimbursements contribute to the market growth in this region[3].

Product Specifics and Usage

Dosage and Administration

Diastat AcuDial is available in specific strengths and syringe sizes, including 10 mg/2 ml and 20 mg/4 ml, with corresponding tip lengths. The AcuDial syringe features a display window and a green "ready" band to ensure accurate dosing[4].

Clinical Use

Diastat AcuDial is used as an add-on therapy for individuals with refractory epilepsy who are already on a stable dosage of at least one anti-epileptic drug. It is administered rectally to treat breakthrough or cluster seizures[4].

Financial Trajectory

Cost and Pricing

The cost of Diastat AcuDial can vary based on several factors, including the treatment plan, insurance coverage, and the pharmacy used. Brand-name drugs like Diastat AcuDial are generally more expensive due to the extensive research and development costs involved. However, generic versions may become available once the patent expires, potentially reducing costs through market competition[1].

Savings Programs and Insurance

Patients may be able to lower the cost of Diastat AcuDial by obtaining a 90-day supply, if approved by their insurance company. Additionally, savings programs and financial assistance may be available from the manufacturer or other sources[1].

Market Drivers and Restraints

Drivers

• Increasing Incidence of Mental Health Disorders: Rising cases of anxiety, insomnia, and alcohol addiction drive the demand for diazepam-based treatments.
• Research and Development: Ongoing clinical trials and new product launches contribute to market growth.
• Awareness and Reimbursement: Increasing awareness about safe application and favorable reimbursement policies support market expansion[3].

Restraints

• Stringent Regulations: Approval processes and regulatory hurdles can slow market growth.
• Side Effects and Withdrawal Symptoms: Concerns about side effects, drug-drug interactions, and withdrawal symptoms can limit adoption.
• Limited Awareness and Diagnosis: Lack of improved diagnosis and limited awareness about the disorder can restrain market growth[3].

Historical Financial Performance

Valeant Pharmaceuticals

Historically, Diastat AcuDial was part of Valeant Pharmaceuticals' product portfolio. In 2006, Valeant reported a 13% increase in sales compared to 2005, with a significant contribution from promoted products, including Diastat AcuDial. The company's restructuring efforts aimed to streamline operations and reduce costs, which included realigning operating regions and reducing overhead costs[5].

Future Outlook

Emerging Markets

The untapped potential in emerging markets such as Asia-Pacific and Latin America is expected to provide lucrative growth opportunities for Diastat AcuDial and other diazepam products. Advancements in therapeutics and increasing awareness about mental health disorders are likely to boost market growth during the forecast period[3].

Clinical Trials and Research

Continued investments in clinical trials for multiple applications of diazepam, along with improvements in reimbursement scenarios, are expected to propel the market forward. The availability of research funds from both public and private bodies will also support the growth of the diazepam market, including Diastat AcuDial[3].

Key Takeaways

• Diastat AcuDial is a critical medication for treating refractory seizure clusters in adults and children.
• The global diazepam market, including Diastat AcuDial, is expected to grow at a CAGR of 3.4% until 2027.
• North America is a key revenue-generating region due to favorable reimbursement policies and high awareness about mental health disorders.
• The cost of Diastat AcuDial can be managed through savings programs and obtaining a 90-day supply.
• Market growth is driven by increasing incidence of mental health disorders and ongoing research, but is restrained by stringent regulations and side effects.

FAQs

1. What is Diastat AcuDial used for?

Diastat AcuDial is used to treat seizure clusters in adults and children aged 2 years and older with refractory epilepsy.

2. How is Diastat AcuDial administered?

Diastat AcuDial is administered rectally using a prefilled syringe with a special molded tip.

3. What are the key drivers of the diazepam market?

Key drivers include the rising incidence of anxiety disorders, insomnia, and alcohol addiction, along with increasing investments in research and development and new product launches.

4. How can patients reduce the cost of Diastat AcuDial?

Patients can reduce costs by obtaining a 90-day supply, if approved by their insurance company, and through savings programs and financial assistance.

5. What are the potential restraints on the diazepam market?

Restraints include stringent regulations, side effects, withdrawal symptoms, and limited awareness and diagnosis of the disorder.

Cited Sources:

1. Medical News Today - Diastat and Diastat AcuDial cost 2024: Coupons and more
2. Valeant Pharmaceuticals International 2007 Annual Report
3. BioSpace - Diazepam Market Analysis By Key Players, Share, Size, Trends ...
4. Medical News Today - Diastat and Diastat Acudial: Dosage, side effects, uses, and more
5. Valeant - Annual Report 10K FINAL[5]