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-nine 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:	68
Clinical Trials:	5
Patent Applications:	4,162
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	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	020648-005	Jul 29, 1997	5,462,740
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	020648-003	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
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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Diastat (Diazepam Rectal Gel)

Overview of Diastat

Diastat, also known as diazepam rectal gel, is a formulation of diazepam designed for the acute management of seizure clusters, which are episodes of increased seizure activity. It is administered rectally, making it a convenient and effective option for patients, especially in outpatient settings.

Market Size and Growth

The global market for acute repetitive seizures, which includes Diastat, has been experiencing significant growth. Here are some key financial metrics:

• The global acute repetitive seizures market was estimated at USD 2.60 billion in 2022 and is expected to grow at a CAGR of 12.4% from 2023 to 2030, reaching USD 6.31 billion by 2030[1][4].

Product Segment Analysis

Diastat Rectal Gel

• Diastat rectal gel is a prominent segment within the acute repetitive seizures market. It is the only FDA-approved drug in its category, and the recent availability of generic versions has further boosted its market presence[4].
• The effectiveness and ease of administration of Diastat rectal gel contribute to its significant revenue share. It is particularly favored due to its rapid action and the fact that it does not require a needle for administration[1][4].

Regional Outlook

Global Market Distribution

• The North American region is currently a major revenue generator for Diastat, driven by factors such as high healthcare expenditure, advanced medical infrastructure, and greater awareness about seizure disorders[1][3].
• However, the Asia Pacific region is expected to grow at the fastest CAGR, driven by increasing healthcare expenditure in countries like India and China. These regions have a large patient base with epilepsy, creating a substantial demand for antiseizure drugs like Diastat[1].

Drivers of Growth

Increasing Incidence of Seizure Disorders

• The rising incidence of epilepsy and other seizure disorders is a significant driver for the growth of the Diastat market. With over 12 million and 10 million cases of epilepsy in India and China, respectively, the demand for effective antiseizure medications is on the rise[1].

Advancements in Therapeutics

• Continuous research and development in the field of neurology and the introduction of novel therapies are driving the market forward. The FDA approval and orphan drug designation for drugs like USL-261 and Diastat have enhanced their market potential[1][4].

Ease of Administration

• The intranasal and rectal routes of administration for drugs like Diastat and USL-261 are preferred due to their ease of use and rapid action. This convenience is a key factor in their higher adoption rates[1][4].

Restraints and Challenges

Regulatory Hurdles

• Stringent regulatory approvals and the need for rigorous clinical trials can slow down the market growth. The approval process for new drugs, especially those designated as orphan drugs, can be lengthy and costly[3].

Side Effects and Safety Concerns

• Diazepam, the active ingredient in Diastat, is associated with side effects such as drowsiness, muscle weakness, and potential for dependence. These safety concerns can limit its prescription and use[3].

Competitive Landscape

Key Players

• The market for acute repetitive seizures is dominated by companies like UCB S.A. and Neurelis, Inc., which are behind the commercialization of USL-261 and VALTOCO. Other players, such as the manufacturers of Diastat, also play a significant role in the market[1].

Business Expansion Strategies

• Companies are focusing on novel product launches, acquisitions, and collaborations to enhance their market position. For example, Neurelis signed an exclusive agreement with Aculys Pharma to commercialize and develop VALTOCO in the Asia Pacific region[1].

Financial Projections

Revenue Growth

• The Diastat segment, as part of the broader acute repetitive seizures market, is expected to contribute significantly to the overall revenue growth. With a projected CAGR of 12.4% from 2023 to 2030, the market is set to expand substantially[1].

Pricing and Reimbursement

• The prices of Diastat and other orphan drugs are typically high due to their specialized nature and the high development costs. However, improvements in reimbursement scenarios and increasing awareness about the safe application of these drugs are expected to support market growth[1][3].

Key Takeaways

• The global acute repetitive seizures market, including Diastat, is growing rapidly driven by increasing healthcare expenditure and the rising incidence of seizure disorders.
• The Asia Pacific region is expected to be a key growth area due to its large patient base and increasing healthcare investments.
• Ease of administration and FDA approvals are significant drivers for the adoption of Diastat.
• Regulatory hurdles and safety concerns are key challenges that need to be addressed.

FAQs

What is Diastat used for?

Diastat, or diazepam rectal gel, is used for the acute management of seizure clusters, which are episodes of increased seizure activity.

What is the current market size of the acute repetitive seizures market?

The global acute repetitive seizures market was estimated at USD 2.60 billion in 2022[1].

What is the expected CAGR of the acute repetitive seizures market from 2023 to 2030?

The market is expected to grow at a CAGR of 12.4% from 2023 to 2030[1].

Which region is expected to grow the fastest in the acute repetitive seizures market?

The Asia Pacific region is expected to grow at the fastest CAGR due to increased healthcare expenditure in developing countries like India and China[1].

What are the main drivers for the growth of the Diastat market?

The main drivers include the increasing incidence of seizure disorders, advancements in therapeutics, and the ease of administration of Diastat[1][3].

Sources

1. Grand View Research: Acute Repetitive Seizures Market Size & Share Report, 2030.
2. MDPI: Benzodiazepine Trajectories and Injurious Fall Risk among US Medicare Beneficiaries.
3. BioSpace: Diazepam Market Analysis By Key Players, Share, Size, Trends, Aftermarket Growth Opportunities, and Regional Forecast to 2027.
4. Verified Market Research: Acute Repetitive Seizures Market Size, Share, Trends, & Forecast.