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-four 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:	47
Clinical Trials:	3
Patent Applications:	4,239
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	021726-004	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
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
Denmark	2266538
Australia	726336
European Patent Office	2147669	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
World Intellectual Property Organization (WIPO)	9846215
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Hong Kong	1137654

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NIRAVAM

Last updated: July 30, 2025

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Introduction

Niravam, bearing the generic name midazolam, is a benzodiazepine used primarily for anesthesia induction, sedation, and procedural sedation. Recognized for its rapid onset and short duration, Niravam’s role in clinical settings underscores its importance in hospitals, outpatient procedures, and emergency care. The commercial landscape of Niravam is shaped by intricate market forces, regulatory environments, and evolving clinical practices, which collectively delineate its financial trajectory.

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Market Overview

Global Market Size and Growth Drivers

The benzodiazepine sector, which includes Niravam, is a sizable segment of the wider central nervous system (CNS) therapeutics market. The acute need for effective sedation during surgeries and diagnostic procedures is the primary demand driver. The global sedatives market was valued at approximately USD 3.8 billion in 2021 and is projected to grow at a CAGR of 4-6% through 2028, fueled by expanding healthcare infrastructure, increasing procedural volumes, and a rising prevalence of chronic illnesses requiring sedation protocols [1].

Niravam’s primary utilization in procedural sedation, anesthesia induction, and conscious sedation significantly benefits from the increasing adoption of minimally invasive procedures, outpatient surgeries, and emergency care where quick-acting sedatives are mandatory.

Regional Market Dynamics

• North America: Dominates due to high healthcare expenditure, advanced medical infrastructure, and prevalent surgical procedures. The U.S. represents the largest share, with hospitals and outpatient facilities adopting Niravam for anesthesia and sedation [2].

• Europe: Progressive adoption driven by regulatory approvals, clinical guidelines favoring benzodiazepines, and an aging population requiring increased procedural interventions.

• Asia-Pacific: Rapidly expanding healthcare infrastructure and a growing patient pool are expected to propel growth, alongside increasing awareness among healthcare professionals.

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Regulatory Environment and Patent Landscape

Regulatory Approvals

Niravam’s approval status varies globally; for instance, it’s approved by the U.S. Food and Drug Administration (FDA) for anesthesia and procedural sedation uses. Regulatory bodies influence the commercial potential through approval timelines, labeling, and safety considerations. Evolving regulatory standards emphasizing patient safety and opioid-sparing approaches impact the market.

Patent and Exclusivity

Although midazolam formulations have faced patent expirations in some jurisdictions, certain proprietary formulations, delivery systems, or analyte-specific patents may extend exclusivity periods. These patent protections influence pricing strategies and market dominance, impacting revenue streams over the patent life.

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Market Challenges

• Regulatory Scrutiny and Safety Concerns: Benzodiazepines can cause dependence, respiratory depression, and other adverse effects. Increasing regulations and safety warnings may hinder broad adoption or lead to reforms in clinical guidelines, impacting sales.

• Generic Competition: The expiration of key patents has led to proliferation of generic midazolam products, exerting downward pressure on prices and profit margins.

• Market Saturation and Cannibalization: In mature markets, penetration reaches a plateau, necessitating diversification or innovation to stimulate growth.

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Competitive Landscape

Niravam faces competition from both branded and generic formulations. Key players include Mylan, Sun Pharmaceutical, and Hospira, among others. Differentiation strategies—such as unique formulations, delivery devices, or enhanced safety profiles—are crucial for maintaining market share.

Emerging alternatives include newer sedatives with improved safety profiles or easier administration routes, which could impact Niravam’s market positioning.

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Financial Trajectory and Revenue Projections

Historical Performance

While specific sales data for Niravam aren’t publicly disclosed, benzodiazepine sales have remained relatively stable with fluctuations corresponding to regulatory influences and shifts in clinical practice. The commercialization of generic midazolam has led to declining average selling prices but increased volume sales.

Forecasting Future Revenue

Considering current market drivers, a conservative CAGR of 3-5% is projected for Niravam sales over the next five years, driven by:

• Rising procedural volumes, especially in outpatient settings.

• Expansion into emerging markets with nascent anesthesia markets.

• Product modifications, such as combining Niravam with novel delivery devices, enhancing usability and safety.

Potential revenue streams will hinge on patent strategies, manufacturing costs, and competitive actions. As patent protections weaken, revenue might plateau or decline unless differentiated formulations or new indications are identified.

Impact of Innovation and Pipeline Developments

Research into alternative benzodiazepine formulations, such as sublingual or nasal sprays, could expand Niravam’s market into novel administration routes with higher convenience, thereby creating new revenue channels.

Furthermore, pipeline developments in related sedation protocols and combination therapies could bolster long-term revenue prospects.

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Market Risks and Opportunities

Risks

• Regulatory and Safety: Stricter guidelines and safety concerns could limit prescribing behaviors.
• Pricing Pressures: Health systems’ focus on cost containment intensified competition among generics.
• New Entrants: Innovative sedatives claiming superior safety or efficacy could erode Niravam’s market share.

Opportunities

• Expanding Indications: Exploring off-label uses or new formulations.
• Emerging Markets: Increased penetration in densely populated regions.
• Operational Efficiency: Developing cost-effective manufacturing and distribution channels.

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Conclusion

Niravam’s market dynamics are defined by its clinical importance, competitive landscape, regulatory environment, and the ongoing shift toward minimally invasive procedures. While its sales trajectory in established markets faces downward pressures due to generic competition, opportunities remain in emerging regions and through formulation innovations. Strategic positioning, patent management, and operational efficiencies will determine Niravam’s financial outlook over the coming years.

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Key Takeaways

• The global sedatives market, with Niravam as a key player, is poised for steady growth driven by procedural volume expansion.
• Patent expirations have increased generic competition, necessitating product differentiation strategies by manufacturers.
• Regulatory scrutiny over safety profiles influences prescribing practices and market stability.
• Innovation in delivery methods and new indications could unlock future revenue streams.
• Significant growth opportunities exist in emerging markets where healthcare infrastructure is improving, although pricing pressures exist across mature regions.

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FAQs

1. What factors influence Niravam’s market share in the global sedatives market?
Market share is influenced by regulatory approvals, safety profile perceptions, competitive pricing of generic equivalents, innovation in formulation, and regional healthcare infrastructure.

2. How does patent expiration affect Niravam’s revenue?
Patent expiration typically introduces generic competitors, leading to price erosion and increased volume sales but reduced per-unit revenue.

3. Are there any significant regulatory hurdles for Niravam’s future commercialization?
Yes, safety concerns, especially related to dependence and respiratory depression, require ongoing regulatory oversight, which may impose prescribing restrictions or safety labeling updates.

4. What emerging markets offer growth potential for Niravam?
Asia-Pacific and Latin America represent promising regions due to expanding healthcare access, increased procedural volumes, and growing healthcare expenditure.

5. How can Niravam’s manufacturers sustain growth amid generic competition?
Through innovative formulations, expanding indications, market diversification, securing new patents or exclusivities, and fostering strategic partnerships.

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References

[1] MarketsandMarkets. (2022). Sedatives Market by Product, Application, End User, and Region - Global Forecast to 2028.

[2] IQVIA. (2022). The Global Use and Adoption Trends of Sedatives in Procedural Medicine.