XANAX Drug Patent Profile

When do Xanax patents expire, and what generic alternatives are available?

Xanax is a drug marketed by Upjohn and is included in two NDAs.

The generic ingredient in XANAX is alprazolam. There are fifteen drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xanax

A generic version of XANAX was approved as alprazolam by NOVITIUM PHARMA on October 19^th, 1993.

Summary for XANAX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	53
Patent Applications:	4,083
Drug Prices:	Drug price information for XANAX
Drug Sales Revenues:	Drug sales revenues for XANAX
What excipients (inactive ingredients) are in XANAX?	XANAX excipients list
DailyMed Link:	XANAX at DailyMed

See drug prices for XANAX

See drug sales revenues for XANAX

Pharmacology for XANAX

Drug Class

Benzodiazepine

US Patents and Regulatory Information for XANAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-003	Jan 17, 2003	AB	RX	Yes	No
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-004	Nov 27, 1985	AB	RX	Yes	No
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-004	Jan 17, 2003	AB	RX	Yes	Yes
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-002	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Upjohn	XANAX	alprazolam	TABLET;ORAL	018276-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	Yes
Upjohn	XANAX XR	alprazolam	TABLET, EXTENDED RELEASE;ORAL	021434-002	Jan 17, 2003	AB	RX	Yes	No

Expired US Patents for XANAX

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

International Patents for XANAX

See the table below for patents covering XANAX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	490626
France	2034999
Germany	2012190
Sweden	387641	ANALOGIFORFARANDE FOR FRAMSTELLNING AV S-TRIAXOLO(4,3-A)(1,4)BENSODIAZEPINER
United Kingdom	1291632
Denmark	449378
Japan	S4940239

XANAX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Xanax (Alprazolam)

Introduction to Xanax (Alprazolam)

Xanax, commonly known by its generic name alprazolam, is a widely prescribed benzodiazepine used primarily to treat anxiety disorders, panic disorders, and in some cases, depression. The market for Xanax is influenced by several key factors, including the increasing prevalence of mental health issues, regulatory environments, and advancements in pharmaceutical technology.

Increasing Prevalence of Mental Health Issues

The global market for alprazolam is significantly driven by the rising prevalence of anxiety and other mental health disorders. According to the Anxiety and Depression Association of America (ADAA), approximately 40 million U.S. adults suffer from anxiety disorders, a number that has been exacerbated by the COVID-19 pandemic[1].

Impact of COVID-19

The COVID-19 pandemic has heightened stress and anxiety levels globally, leading to an increased demand for anxiolytics like Xanax. This surge in demand is expected to continue as the world grapples with the long-term psychological impacts of the pandemic[2].

Regulatory Environment and Health Policies

Health policies and regulatory frameworks play a crucial role in the growth of the alprazolam market. In the U.S., for instance, eligible residents receive treatment coverage through Medicaid for mental health services and Medicare Part A for the treatment of depression and anxiety. Such policies enhance accessibility to mental health treatments, including medications like Xanax[1].

Competitive Landscape

The alprazolam market is characterized by a competitive landscape with several key players. Companies such as Pfizer Inc., Sandoz, Taj Pharmaceuticals Limited, AdvaCare Pharma, and Terrace Pharmaceuticals Ltd. are major contributors to the market. These companies engage in strategic activities to increase product availability and develop new formulations to stay competitive[3].

Generic Versions and Patent Exclusivity

The expiration of Xanax's patent exclusivity has allowed generic versions to enter the market, potentially reducing costs and increasing accessibility. This shift is expected to further drive the market growth as more affordable options become available to a broader population[2].

Market Size and Growth Projections

Global Market Size

The global benzodiazepine drugs market, which includes alprazolam, is valued at approximately $2.35 billion in 2022 and is forecasted to reach $3.1 billion by 2032, growing at a CAGR of 2.8%[4].

Regional Insights

North America is expected to dominate the global alprazolam market due to better healthcare infrastructure, high awareness of mental health issues, and the presence of major industry players. The region accounts for a significant market share, with the U.S. being a key market due to its high prevalence of mental disorders[1][3].

Fastest Growing Region

The Asia Pacific region is estimated to be the fastest growing market for alprazolam, driven by increasing awareness of mental health issues and improving healthcare infrastructure[3].

Financial Trajectory

Revenue Growth

The alprazolam segment within the benzodiazepine drugs market holds a significant market share, approximately 29.6%. This segment is expected to grow at a CAGR of 3%, contributing substantially to the overall revenue growth of the benzodiazepine market[4].

Project Economics for Manufacturing

Setting up an alprazolam manufacturing plant involves significant capital investments, operating expenses, and regulatory approvals. The project economics include detailed analyses of capital expenditure (CapEx), operating expenditure (OpEx), income projections, taxation, depreciation, and liquidity analysis. These factors are crucial for understanding the financial viability of such projects[2].

Trends and Evolving Market Dynamics

Combined Therapies

There is a growing trend towards combined therapies where Xanax is prescribed alongside psychotherapy or other medications to achieve more holistic mental health treatment. This approach is expected to influence prescription patterns and market demand[2].

Alternative Treatments

The exploration of alternative treatments such as cognitive-behavioral therapy and mindfulness is shaping the landscape of anxiety management. While these alternatives may reduce the reliance on medications like Xanax, they also highlight the need for comprehensive mental health solutions, which can include pharmaceuticals as part of a broader treatment plan[2].

Research and Development

Increased research and development activities aimed at developing new alprazolam products and formulations are expected to bolster market growth. For example, clinical studies evaluating the relative bioavailability of alprazolam in different forms are contributing to the market's expansion[3].

Key Players and Market Concentration

The alprazolam powder market is consolidated, with a few key players operating globally and regionally. These companies, such as Pfizer Inc., Sandoz, and Taj Pharmaceuticals Limited, continuously engage in strategic activities to increase product availability and market share[3].

Illustrative Statistics

• Market Size: The global benzodiazepine drugs market, including alprazolam, is projected to reach $3.1 billion by 2032[4].
• CAGR: The alprazolam segment is expected to grow at a CAGR of 3%[4].
• Prevalence of Mental Health Issues: An estimated 3.8% of the global population was diagnosed with depression in 2023, with women being 50% more likely than men to experience depression[3].
• Regional Market Share: North America accounts for approximately 37.2% of the benzodiazepine drugs market[4].

Quotes from Industry Experts

"The increasing recognition and destigmatization of mental health issues have led to a surge in the demand for medications like Xanax."

• Industry expert, highlighting the growing need for mental health support[2].

Highlight

"According to the World Health Organization (WHO), an estimated 3.8% of people in the global population were diagnosed with depression, including 5.7% over 60 years and 5% below 60 years (4% of males and 6% of women)."

• World Health Organization (WHO), March 2023 update[3].

Key Takeaways

• The global alprazolam market is driven by the increasing prevalence of anxiety and other mental health disorders.
• North America dominates the market due to better healthcare infrastructure and high awareness of mental health issues.
• The Asia Pacific region is the fastest growing market for alprazolam.
• The market is expected to grow at a CAGR of 2.8% to reach $3.1 billion by 2032.
• Combined therapies and alternative treatments are shaping the market dynamics.
• Key players are engaging in strategic activities to increase product availability and market share.

FAQs

What is the current market size of the global benzodiazepine drugs market, including alprazolam?

The global benzodiazepine drugs market is valued at approximately $2.35 billion in 2022[4].

Which region is expected to dominate the global alprazolam market?

North America is expected to dominate the global alprazolam market due to its better healthcare infrastructure and high prevalence of mental disorders[1][3].

What is the expected CAGR for the alprazolam segment within the benzodiazepine drugs market?

The alprazolam segment is expected to grow at a CAGR of 3%[4].

Who are the key players in the alprazolam market?

Key players include Pfizer Inc., Sandoz, Taj Pharmaceuticals Limited, AdvaCare Pharma, and Terrace Pharmaceuticals Ltd.[3].

How has the COVID-19 pandemic impacted the demand for Xanax?

The COVID-19 pandemic has heightened stress and anxiety levels globally, leading to an increased demand for anxiolytics like Xanax[2].

Sources

1. Coherent Market Insights - Alprazolam Tablets Market Size, Trends And Forecast To 2028
2. IMARC Group - Alprazolam (Xanax) Manufacturing Plant Report 2024
3. Mordor Intelligence - Alprazolam Powder Market Size & Share Analysis - Growth Trends
4. Fact.MR - Benzodiazepine Drugs Market Size, Share & Growth Trajectory 2032