NIRAVAM Drug Patent Profile

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

Niravam is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in NIRAVAM 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 Niravam

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

Summary for NIRAVAM

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	3
Patent Applications:	4,477
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NIRAVAM
What excipients (inactive ingredients) are in NIRAVAM?	NIRAVAM excipients list
DailyMed Link:	NIRAVAM at DailyMed

Recent Clinical Trials for NIRAVAM

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

Sponsor	Phase
Actavis Inc.	Phase 1
UCB Pharma	Phase 4

See all NIRAVAM clinical trials

Paragraph IV (Patent) Challenges for NIRAVAM

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 NIRAVAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-001	Jan 19, 2005		DISCN	Yes	No
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-004	Jan 19, 2005		DISCN	Yes	No
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-002	Jan 19, 2005		DISCN	Yes	No
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-003	Jan 19, 2005		DISCN	Yes	No

Expired US Patents for NIRAVAM

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
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-001	Jan 19, 2005
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-004	Jan 19, 2005
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-003	Jan 19, 2005
Ucb Inc	NIRAVAM	alprazolam	TABLET, ORALLY DISINTEGRATING;ORAL	021726-002	Jan 19, 2005

International Patents for NIRAVAM

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

Country	Patent Number	Title	Estimated Expiration
Spain	2525720
Portugal	2147669
Japan	2008001726	RAPIDLY DISSOLVING ROBUST DOSAGE FORM
Denmark	2147669
Australia	6896998

NIRAVAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NIRAVAM (Alprazolam)

Introduction to NIRAVAM (Alprazolam)

NIRAVAM, a brand name for alprazolam, is a widely used benzodiazepine drug primarily prescribed for the treatment of anxiety and panic disorders. Here, we delve into the market dynamics and financial trajectory of alprazolam, highlighting key drivers, market segmentation, and future projections.

Market Size and Growth

The global benzodiazepine drugs market, which includes alprazolam, is experiencing significant growth. The market size is projected to increase from $3.31 billion in 2023 to $3.53 billion in 2024, with a compound annual growth rate (CAGR) of 6.6%. By 2028, the market is expected to reach $4.59 billion, growing at a CAGR of 6.8%[1].

Specifically, the alprazolam market is forecasted to grow by USD 90.33 million during the period of 2020-2024, with a CAGR of around 4%[4].

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. For instance, the proportion of people with a probable mental disorder between 17 and 19 years old increased significantly from 17.4% in 2021 to 25.7% in 2022 in the UK[1].

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. The hectic lifestyles of both middle-aged and older populations, as well as younger individuals, contribute to this trend[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[2].

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[2].

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[2].

By Route of Administration

Alprazolam is administered through various routes, including oral, parenteral, and other routes. The oral route is the most common due to its ease of administration and patient compliance[1].

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[2].

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[2].

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. 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[2].

Segment Value

Alprazolam holds a substantial share of the benzodiazepine drugs market, with a market share of approximately 29.2% in 2021. This segment is expected to continue growing due to its efficacy in treating anxiety and panic disorders[2].

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[2].

Challenges and Opportunities

Challenges

The alprazolam 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. Regulatory measures are necessary to control the adverse effects associated with long-term alprazolam use[2].

Opportunities

• Combination Therapies: The rise of combination therapies with benzodiazepines offers new opportunities for market growth.
• New Formulations: Development of sublingual and transdermal benzodiazepine formulations can enhance patient compliance and reduce side effects.
• Artificial Intelligence: Adoption of artificial intelligence for predictive modeling in anxiety treatment can improve treatment outcomes and drive market growth[1].

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[4].

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[2].

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[2].

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[2].

Q: How is the alprazolam market segmented by application?

A: The alprazolam market is segmented into panic disorders, anxiety, depression, and insomnia, with anxiety occupying the largest market share[2].

Sources

1. The Business Research Company: Global Benzodiazepine Drugs Market Report 2024.
2. Drug Patent Watch: Generic ALPRAZOLAM INN entry, pharmaceutical patent expiration.
3. Digital Commons Library: The Influence Of Brand Equity On Prescriber Behaviour In A Multisource Drug Market.
4. Business Wire: COVID-19 Impact and Recovery Analysis | Global Alprazolam Market 2020-2024.
5. NCBI: Evidence reviews for pharmacological interventions for the prevention of PTSD.