Naloxone hydrochloride; pentazocine hydrochloride - Generic Drug Details

What are the generic sources for naloxone hydrochloride; pentazocine hydrochloride and what is the scope of freedom to operate?

Naloxone hydrochloride; pentazocine hydrochloride is the generic ingredient in two branded drugs marketed by Lupin, Sun Pharm Inds Ltd, Watson Labs, and Sanofi Aventis Us, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for naloxone hydrochloride; pentazocine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	2
DailyMed Link:	naloxone hydrochloride; pentazocine hydrochloride at DailyMed

Recent Clinical Trials for naloxone hydrochloride; pentazocine hydrochloride

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

Sponsor	Phase
University of Washington	Phase 1
National Institute on Aging (NIA)	Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1

See all naloxone hydrochloride; pentazocine hydrochloride clinical trials

Pharmacology for naloxone hydrochloride; pentazocine hydrochloride

Drug Class	Opioid Antagonist Partial Opioid Agonist/Antagonist
Mechanism of Action	Competitive Opioid Antagonists Opioid Antagonists Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for naloxone hydrochloride; pentazocine hydrochloride

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N02AD	Benzomorphan derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

US Patents and Regulatory Information for naloxone hydrochloride; pentazocine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075735-001	Jul 11, 2001	AB	RX	No	No
Sun Pharm Inds Ltd	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	075523-001	Mar 17, 2000	AB	RX	No	No
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982		DISCN	No	No
Watson Labs	NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	074736-001	Jan 21, 1997	AB	RX	No	Yes

Expired US Patents for naloxone hydrochloride; pentazocine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982

Market Dynamics and Financial Trajectory for Naloxone Hydrochloride and Pentazocine Hydrochloride

Last updated: July 30, 2025

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Introduction

As the opioid crisis escalates globally, the demand for reversal and analgesic agents such as naloxone hydrochloride and pentazocine hydrochloride is experiencing notable shifts. These two drugs occupy critical niches within emergency response and pain management sectors, respectively, influencing their market dynamics and financial trajectories. This report offers an extensive analysis of current trends, competitive landscapes, regulatory considerations, and future growth prospects for naloxone hydrochloride and pentazocine hydrochloride.

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Market Overview

Naloxone Hydrochloride: The Opioid Overdose Antidote

Naloxone hydrochloride (commonly marketed as Narcan) is an opioid antagonist primarily used to reverse acute opioid overdose. Its importance has surged amid the opioid epidemic, with global consumption driven by increased opioid misuse and overdose fatalities.

The global naloxone market was valued at approximately USD 1.56 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 10.2% through 2030, reaching over USD 3 billion. Growth drivers include rising overdose cases, increased awareness, and regulatory support for widespread naloxone distribution.

Pentazocine Hydrochloride: The Analgesic Scope

Pentazocine hydrochloride, a synthetic opioid analgesic exhibiting mixed agonist-antagonist activity, is utilized for moderate to severe pain management—particularly in clinical settings where opioid sparing is desirable. The global pentazocine market stood at approximately USD 150 million in 2022, with a projected CAGR of 4.5% until 2030. Its growth is somewhat constrained due to concerns around dependency potential and the emergence of alternative analgesics, including non-opioid options.

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Key Market Drivers

For Naloxone Hydrochloride:

• Escalating Opioid Crisis: The rising prevalence of opioid-related overdoses worldwide remains the dominant driver. According to the CDC, over 100,000 overdose deaths occurred in the US in a 12-month period ending April 2021, primarily due to opioids [1].

• Regulatory Endorsements and Policy Initiatives: Governments are mandating naloxone availability in various public spaces and expanding access programs. Several countries have authorized over-the-counter (OTC) sales, broadening accessibility.

• Innovative Delivery Routes: Development of user-friendly formulations (intranasal sprays, auto-injectors) enhances administration that can be performed by non-medical personnel, broadening distribution channels.

For Pentazocine Hydrochloride:

• Clinical Adoption in Pain Management: Despite concerns around dependency, pentazocine remains relevant, especially in settings requiring analgesics with lower respiratory depression risk compared to full agonists.

• Generic Market Presence: Availability of multiple generic formulations reduces costs, supporting ongoing demand.

• Strategic Focus on Analgesic Combinations: Pentazocine is often combined with other agents, expanding its utility and market penetration.

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Market Challenges and Barriers

For Naloxone Hydrochloride:

• Patent Expiry and Generic Competition: Several naloxone formulations are off-patent, leading to significant price erosion and margin compression for branded products.

• Regulatory Variability: Different jurisdictions impose varying approval pathways, complicating global market expansion.

• Stigma and Education Barriers: Despite increased awareness, stigma associated with opioid misuse and overdose can hinder public acceptance of naloxone programs.

For Pentazocine Hydrochloride:

• Dependency and Side Effects: Concerns about abuse potential and adverse effects limit clinician prescribing, especially amid the opioid epidemic's focus on reducing dependency.

• Competition from Newer Analgesics: Non-opioid pain management options and reformulations target similar therapeutic needs, challenging pentazocine's market share.

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Regulatory Landscape

Naloxone

Key regulatory trends include:

• The US FDA's recent moves to allow OTC sales of naloxone, aiming to increase access. As of 2021, multiple states have initiated standing orders to facilitate pharmacy sales without prescriptions [2].

• EMA approval for various intranasal formulations enhances Europe’s access framework.

Pentazocine

Primarily approved in select markets, regulatory authorities continue to monitor dependency concerns, with some countries re-evaluating its authorized indications or reducing prescribing guidelines.

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Financial Trajectory Analysis

Revenue Trends

• Naloxone: The surging demand, combined with policies expanding access, underpins a robust revenue trajectory. Despite pricing pressures due to generics, volume growth compensates, especially in public health programs.

• Pentazocine: Stable but modest growth; revenues are declining marginally due to substitution by newer analgesics, though chronic pain management remains an ongoing application.

Investment Trends

• Pharmaceutical companies demonstrate increased R&D investments into innovative naloxone delivery systems, including nasal sprays and auto-injectors, promising higher margins and market differentiation.

• Limited innovation in pentazocine formulations indicates a mature market with potentially declining financial significance.

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Future Outlook and Market Opportunities

Naloxone Hydrochloride

• Emerging Markets: Expansion in Asia-Pacific, Latin America, and Africa presents significant growth potential driven by rising opioid overdose cases and unmet medical needs.

• Combination Therapies: Collaborations targeting multi-indication formulations and smart delivery devices could catalyze new revenue streams.

• Policy and Public Health Push: Continued government and NGO initiatives will sustain demand, with potential for increased funding and subsidy programs.

Pentazocine Hydrochloride

• Niche Role Retention: Limited growth unless novel formulations or indications emerge to mitigate dependency risks.

• Alternative Analgesic Developments: Competition from non-opioid agents (e.g., nerve-blocking agents, cannabinoid therapeutics) may further diminish its market relevance.

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Key Takeaways

• Market expansion for naloxone is strongly propelled by global efforts to combat opioid overdose mortality, innovative drug delivery systems, and regulatory shifts toward OTC availability.

• While the pentazocine market maintains a steady presence in pain management, it faces headwinds from regulatory scrutiny and competitive alternatives, leading to a relatively flat or declining financial trajectory.

• Patent expiries and generic proliferation significantly impact revenue streams for both drugs, emphasizing the importance of differentiation and innovation, especially within naloxone formulations.

• Emerging markets and public health initiatives represent critical avenues for growth in naloxone sales, with considerable investment in awareness and distribution infrastructure.

• Regulatory harmonization and expanded access programs are likely to sustain and elevate the market size for naloxone, whereas pentazocine’s demand outlook remains more subdued amid evolving pain management paradigms.

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FAQs

1. How will recent regulatory changes influence the naloxone market?
Regulatory approvals for OTC sales and public health mandates in various countries are expected to significantly increase naloxone accessibility, boosting sales volumes despite price competition from generics.

2. What are the main drivers behind the growth of the naloxone market?
The opioid overdose epidemic, government-led distribution initiatives, innovative delivery methods, and expanded legal approval for wider access principally drive market growth.

3. Are there any new formulations of pentazocine under development?
Currently, limited innovation exists. Most formulations remain generic, with incremental improvements focusing on delivery ease rather than novel indications.

4. How do pricing pressures impact the profitability of naloxone manufacturers?
The proliferation of generic formulations has led to reduced prices, compressing margins; however, high demand and volume scalability typically offset these pressures.

5. What strategic moves can companies make to capitalize on the naloxone market’s growth?
Investing in formulation innovation, expanding access in emerging markets, forming partnerships with public health agencies, and emphasizing education campaigns will position companies favorably.

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References

[1] Centers for Disease Control and Prevention (CDC). (2022). Overdose Death Rates.
[2] U.S. Food and Drug Administration (FDA). (2021). Over-the-Counter Naloxone Approvals.