Alprazolam - Generic Drug Details

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

Alprazolam is the generic ingredient in four branded drugs marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Ani Pharms, Apotex Inc, Aurobindo Pharma, Endo Operations, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Norvium Bioscience, Sandoz Inc, Upjohn, Ucb Inc, Chartwell Rx, Ivax Sub Teva Pharms, Mylan, Natco, Novitium Pharma, Oxford Pharms, Sandoz, Strides Pharma, Sun Pharm, and Watson Labs, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are fifteen drug master file entries for alprazolam. Thirty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for alprazolam

US Patents:	0
Tradenames:	4
Applicants:	26
NDAs:	39
Drug Master File Entries:	15
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	96
Patent Applications:	6,038
Drug Prices:	Drug price trends for alprazolam
Drug Sales Revenues:	Drug sales revenues for alprazolam
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for alprazolam
What excipients (inactive ingredients) are in alprazolam?	alprazolam excipients list
DailyMed Link:	alprazolam at DailyMed

See drug prices for alprazolam

See drug sales revenues for alprazolam

Recent Clinical Trials for alprazolam

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

Sponsor	Phase
Centre Hospitalier Universitaire Saint Pierre	N/A
Takeda	Phase 1
UCB Biopharma SRL	Phase 3

See all alprazolam clinical trials

Generic filers with tentative approvals for ALPRAZOLAM

Applicant	Application No.	Strength	Dosage Form
		1MG	TABLET;ORAL
		0.5MG	TABLET;ORAL
		0.25MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for alprazolam

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for alprazolam

Anti-Anxiety Agents

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for alprazolam

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ALPRAZOLAM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NIRAVAM	Orally Disintegrating Tablets	alprazolam	0.25 mg, 0.5 mg, 1 mg and 2 mg	021726	1	2005-12-27

US Patents and Regulatory Information for alprazolam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ALPRAZOLAM	alprazolam	TABLET;ORAL	074909-001	Mar 25, 1998	AB	RX	No	No
Ani Pharms	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	077725-001	Jul 31, 2006		DISCN	No	No
Watson Labs	ALPRAZOLAM	alprazolam	TABLET;ORAL	074479-003	Jan 21, 1997		DISCN	No	No
Mylan	ALPRAZOLAM	alprazolam	TABLET;ORAL	074215-004	Jan 27, 1994		DISCN	No	No
Chartwell Rx	ALPRAZOLAM	alprazolam	TABLET;ORAL	207507-001	Jul 9, 2018	AB	RX	No	No

Expired US Patents for alprazolam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-003	Jan 19, 2005
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-002	Approved Prior to Jan 1, 1982
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-004	Nov 27, 1985
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-001	Approved Prior to Jan 1, 1982
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-001	Jan 19, 2005

Alprazolam Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alprazolam

Introduction

Alprazolam, a high-potency triazolobenzodiazepine, is widely used for the treatment of anxiety and panic disorders. The market for alprazolam is influenced by several key factors, including the increasing prevalence of mental health disorders, advancements in pharmaceutical research, and regulatory environments.

Market Size and Growth

The global alprazolam market is projected to experience significant growth over the coming years. According to Technavio, the market is expected to grow by USD 90.33 million during the period of 2020-2024, with a CAGR of around 4%[1].

In the broader context of the benzodiazepine drugs market, alprazolam holds a substantial share. By 2021, the alprazolam segment accounted for approximately 29.2% of the market and is expected to grow at a CAGR of 3% from 2022 to 2032[2].

Drivers of Growth

Several factors are driving the growth of the alprazolam market:

Increasing Prevalence of Anxiety and Panic Disorders

The rising cases of anxiety and panic disorders globally are a major driver. As mental health issues become more prevalent, the demand for effective treatments like alprazolam increases[1][2][4].

Urbanization and Work Pressure

Speedy urbanization and the current work culture have significantly increased mental health problems, creating a huge growth opportunity for alprazolam manufacturers[2][4].

Pharmaceutical Research and Development

Investments in healthcare R&D have led to the introduction of novel synthesized benzodiazepines, including alprazolam, which are more effective and have fewer side effects. This has amplified the sales of benzodiazepine drugs, including alprazolam[2].

Use in New Research Areas

The use of alprazolam in new research areas, such as chemotherapy-induced nausea and vomiting, is also anticipated to boost the market growth[4].

Regional Insights

North America

North America is expected to dominate the global alprazolam market due to the high prevalence of anxiety and related conditions, coupled with higher FDA approvals of alprazolam drugs by major players in the region[4].

Asia Pacific

The Asia Pacific region is also a significant market, driven by increasing awareness of healthcare, stress conditions, and a surge in healthcare expenditure. The presence of a large number of pharmaceutical companies in this region further supports market growth[4].

Market Segmentation

By Application

The alprazolam market is segmented into panic disorders, anxiety, depression, and insomnia. Anxiety is projected to occupy the largest market share during the forecast period due to the rise in prevalence of anxiety and panic disorders[4].

By End-User

The market is segmented into research institutes, pharmaceutical companies, and others (hospitals and clinics). The segment comprising hospitals and clinics is expected to expand at a significantly higher CAGR during the forecast period[4].

Financial Trajectory

Market Value

The global benzodiazepine drugs market, which includes alprazolam, is forecasted to reach a market size of US$ 3.1 billion by 2032, growing at a CAGR of 2.8% from 2022 to 2032[2].

Segment Value

The alprazolam segment is anticipated to reach a value of US$ 768.09 million by 2026, expanding at a CAGR of 2.9% during the forecast period[3].

Financial Expenditure

In terms of financial expenditure, the total projected financial expenditure for benzodiazepines in 2032 is estimated at 14.22 million euros, with alprazolam expenditures expected to be around 4.12 million euros[5].

Challenges and Regulatory Environment

Side Effects and Dependence

Long-term use of alprazolam is associated with several adverse effects, including memory loss, Alzheimer's disease, dependence, addiction, and increased risk of falls and traffic accidents. These side effects necessitate regulatory measures to control the use of alprazolam[5].

Regulatory Restrictions

Alprazolam is banned in several countries, including Australia and New Zealand, due to its side effects. Stringent government rules and regulations on the usage of alprazolam products are expected to hinder market growth[4].

Key Players

The global alprazolam market includes key players such as Pfizer Inc., Akorn Inc., Hikma, Hameln Pharmaceutical, Accord, Troylab, Amneal Pharmaceuticals LLC, and Apotex Inc. These companies play a crucial role in the development, manufacturing, and distribution of alprazolam[2].

Conclusion

The alprazolam market is poised for significant growth driven by the increasing prevalence of anxiety and panic disorders, urbanization, and advancements in pharmaceutical research. However, it also faces challenges related to side effects and regulatory restrictions.

Key Takeaways

• The global alprazolam market is expected to grow at a CAGR of around 4% from 2020 to 2024.
• Alprazolam holds a substantial share of the benzodiazepine drugs market, with a market share of approximately 29.2% in 2021.
• The market is driven by the increasing prevalence of anxiety and panic disorders, urbanization, and pharmaceutical R&D.
• North America and the Asia Pacific region are key markets for alprazolam.
• The segment is expected to reach a value of US$ 768.09 million by 2026.
• Regulatory measures are necessary to control the adverse effects associated with long-term alprazolam use.

FAQs

Q: What is the projected growth rate of the global alprazolam market from 2020 to 2024?

A: The global alprazolam market is expected to grow at a CAGR of around 4% from 2020 to 2024[1].

Q: Which region is expected to dominate the global alprazolam market?

A: North America is expected to dominate the global alprazolam market due to the high prevalence of anxiety and related conditions[4].

Q: What are the main drivers of the alprazolam market?

A: The main drivers include the increasing prevalence of anxiety and panic disorders, urbanization, and advancements in pharmaceutical research[1][2][4].

Q: What are the potential challenges facing the alprazolam market?

A: The market faces challenges related to side effects, dependence, and regulatory restrictions. Long-term use of alprazolam is associated with several adverse effects, and it is banned in several countries[4][5].

Q: Who are the key players in the global alprazolam market?

A: Key players include Pfizer Inc., Akorn Inc., Hikma, Hameln Pharmaceutical, Accord, Troylab, Amneal Pharmaceuticals LLC, and Apotex Inc.[2].

Sources

1. Technavio: Global Alprazolam Market 2020-2024 | Technavio - Business Wire
2. Fact.MR: Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032
3. BioSpace: Benzodiazepine Drugs Market is Presumed to be Valued at US $2.617.16 Mn by 2026
4. Global Market Estimates: Global Alprazolam Market Analysis|Size & Forecasts
5. PubMed: Evolving Trends and Economic Burden of Benzodiazepine Use