Estazolam - Generic Drug Details

What are the generic drug sources for estazolam and what is the scope of patent protection?

Estazolam is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Sa, Novitium Pharma, Watson Labs, and Abbott, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for estazolam. Four suppliers are listed for this compound.

Summary for estazolam

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	6,259
Drug Prices:	Drug price trends for estazolam
What excipients (inactive ingredients) are in estazolam?	estazolam excipients list
DailyMed Link:	estazolam at DailyMed

See drug prices for estazolam

Recent Clinical Trials for estazolam

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

Sponsor	Phase
The First Affiliated Hospital with Nanjing Medical University	N/A
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine	Phase 4
Haitao Tu	Phase 4

See all estazolam clinical trials

Pharmacology for estazolam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for estazolam

Anti-Anxiety Agents

Anticonvulsants

GABA Modulators

Anatomical Therapeutic Chemical (ATC) Classes for estazolam

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for estazolam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	ESTAZOLAM	estazolam	TABLET;ORAL	074826-002	Jul 3, 1997	AB	RX	No	No
Watson Labs	ESTAZOLAM	estazolam	TABLET;ORAL	074818-001	Aug 19, 1997	AB	RX	No	No
Dr Reddys Labs Sa	ESTAZOLAM	estazolam	TABLET;ORAL	074921-001	Jul 10, 1997	AB	RX	No	No
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990		DISCN	Yes	No
Novitium Pharma	ESTAZOLAM	estazolam	TABLET;ORAL	074826-001	Jul 3, 1997	AB	RX	No	No
Watson Labs	ESTAZOLAM	estazolam	TABLET;ORAL	074818-002	Aug 19, 1997	AB	RX	No	No

Expired US Patents for estazolam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990

Estazolam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Estazolam

Introduction to Estazolam

Estazolam is a benzodiazepine used primarily for the short-term treatment of insomnia. It belongs to the class of central nervous system (CNS) depressants, which slow down the nervous system to help individuals fall asleep and stay asleep[5].

Global Market Size and Growth

The global market for estazolam has been steadily growing, driven by the increasing prevalence of insomnia and the need for effective pharmacological treatments. As of 2023, the global market for estazolam was estimated to be worth approximately $185 million. This market is forecast to expand to a readjusted size of $242.9 million by 2030, indicating a significant growth trajectory over the next several years[1].

Market Drivers

Several factors are driving the growth of the estazolam market:

Increasing Prevalence of Insomnia

Insomnia is a widespread sleep disorder that affects a substantial portion of the global population. The rising incidence of insomnia, particularly among adults, is a major driver for the demand of pharmacological treatments like estazolam[2].

Limited Availability of Alternative Treatments

While cognitive-behavioral therapy for insomnia (CBT-I) is recommended as a first-line treatment, not all patients can access or benefit from this therapy. This limitation makes pharmacotherapy, including estazolam, a necessary option for many patients[2].

Clinical Recommendations

Clinical practice guidelines suggest the use of benzodiazepines and benzodiazepine receptor agonists, such as estazolam, for the short-term treatment of insomnia. These recommendations from reputable medical organizations help in boosting the market demand for estazolam[2].

Market Challenges

Despite the growth potential, the estazolam market faces several challenges:

Side Effects and Safety Concerns

Estazolam is associated with several side effects, including drowsiness, dizziness, and the risk of physical dependence. These safety concerns can limit its long-term use and impact market growth. Serious side effects such as respiratory depression, especially when combined with other medications, are significant concerns[3][5].

Regulatory Scrutiny

The use of benzodiazepines, including estazolam, is under continuous regulatory scrutiny due to their potential for abuse and dependence. Strict regulations and monitoring can affect the market dynamics[5].

Competition from Other Sleep Aids

The market for sleep aids is competitive, with various other medications and non-pharmacological treatments available. This competition can impact the market share of estazolam[2].

Financial Trajectory

The financial trajectory of estazolam is influenced by several key factors:

Revenue Growth

The projected growth from $185 million in 2023 to $242.9 million by 2030 indicates a steady increase in revenue. This growth is driven by the increasing demand for effective sleep treatments and the limited availability of alternative therapies[1].

Market Share and Ranking

Estazolam holds a significant position in the global sleep aid market, particularly in the segment of benzodiazepines. Its market share is expected to remain stable or slightly increase as it continues to be prescribed for short-term insomnia treatment[4].

Cost and Pricing

The cost of estazolam can vary based on geographical location, availability, and regulatory factors. However, it generally remains within the affordable range for many patients, contributing to its continued use and market growth[5].

Regional Market Analysis

The market for estazolam varies by region, influenced by local healthcare systems, regulatory environments, and the prevalence of insomnia.

North America and Europe

These regions have well-established healthcare systems and a high prevalence of insomnia, contributing to a significant market share for estazolam. The presence of stringent regulations, however, can impact the market dynamics in these regions[1].

Asia-Pacific and Latin America

These regions are experiencing rapid growth in the demand for sleep aids due to increasing awareness and improving healthcare infrastructure. Estazolam is expected to see substantial growth in these markets over the coming years[1].

Competitive Landscape

The competitive landscape for estazolam includes other benzodiazepines and non-benzodiazepine sleep aids:

Benzodiazepines

Other benzodiazepines like triazolam, temazepam, and zolpidem compete with estazolam in the market. These medications have similar indications and side effect profiles[2].

Non-Benzodiazepine Sleep Aids

Medications like eszopiclone, zaleplon, and suvorexant also compete in the sleep aid market. These drugs may offer different side effect profiles and mechanisms of action, attracting patients who are wary of benzodiazepines[2].

Future Outlook

The future outlook for estazolam is positive, driven by the ongoing need for effective sleep treatments:

Continued Demand

The demand for pharmacological treatments for insomnia is expected to continue, ensuring a stable market for estazolam[1].

Research and Development

Ongoing research into the safety and efficacy of estazolam, as well as the development of new formulations or delivery methods, could enhance its market position[2].

Regulatory Environment

Changes in regulatory policies or guidelines could impact the market dynamics. However, given the established use of estazolam, it is likely to remain a viable treatment option[5].

Key Takeaways

• Market Growth: The global estazolam market is projected to grow from $185 million in 2023 to $242.9 million by 2030.
• Drivers: Increasing prevalence of insomnia, limited availability of alternative treatments, and clinical recommendations.
• Challenges: Side effects, safety concerns, regulatory scrutiny, and competition from other sleep aids.
• Financial Trajectory: Steady revenue growth driven by increasing demand and stable market share.
• Regional Analysis: Significant market presence in North America and Europe, with growing demand in Asia-Pacific and Latin America.
• Competitive Landscape: Competition from other benzodiazepines and non-benzodiazepine sleep aids.

FAQs

1. What is estazolam used for? Estazolam is used for the short-term treatment of insomnia, helping individuals fall asleep and stay asleep[5].

2. What are the common side effects of estazolam? Common side effects include drowsiness, dizziness, weakness, dry mouth, and constipation. Serious side effects can include respiratory depression and physical dependence[3][5].

3. Can estazolam be used long-term? Estazolam is recommended for short-term use only, typically 7 to 10 days, due to the risk of physical dependence and other side effects[5].

4. How does estazolam compare to other sleep aids? Estazolam competes with other benzodiazepines and non-benzodiazepine sleep aids. It offers a similar mechanism of action to other benzodiazepines but may have different side effect profiles compared to non-benzodiazepine sleep aids[2].

5. What are the regulatory considerations for estazolam? Estazolam is under regulatory scrutiny due to its potential for abuse and dependence. Patients must be monitored carefully, and the medication should be used as directed by a healthcare provider[5].

Cited Sources

1. Valuates Reports: Estazolam - Market, Report Size, Worth, Revenue, Growth, Industry ...
2. American Academy of Sleep Medicine: Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults.
3. MedlinePlus: Estazolam: MedlinePlus Drug Information.
4. Market Research Reports: Estazolam - Global Market Share and Ranking, Overall Sales and Demand Forecast 2024-2030.
5. Mayo Clinic: Estazolam (oral route) - Mayo Clinic.