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Last Updated: December 22, 2024

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for naloxone hydrochloride; pentazocine hydrochloride and what is the scope of patent protection?

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
Office of Research and Women's Health (ORWH)	Phase 1
National Center for Advancing Translational Science (NCATS)	Phase 1
University of Washington	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

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

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Glossary

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

Expired US Patents for NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE

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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	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Naloxone Hydrochloride

Introduction

Naloxone hydrochloride, a potent opioid antagonist, has become a critical component in the fight against the opioid epidemic. Here, we delve into the market dynamics and financial trajectory of naloxone hydrochloride, highlighting key factors driving its growth and future projections.

Market Size and Growth Projections

The naloxone market is poised for significant growth. As of 2024, the market is valued at USD 1,341.5 million and is expected to reach USD 2,683.9 million by 2031, growing at a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Opioid Overdose Cases

The rising prevalence of opioid overdose cases globally is a primary driver of the naloxone market. With increased opioid prescriptions for chronic pain management, the incidence of opioid overdoses has surged, necessitating the use of naloxone as an antidote to reverse these overdoses[1].

Favorable Government Policies

Government policies and programs aimed at increasing public awareness and availability of naloxone are crucial. Many jurisdictions have implemented policies to expand naloxone access, including required health insurance coverage and state model laws facilitating its distribution. For instance, the White House has proposed a state model law to increase naloxone access, which includes required health insurance coverage[3].

Public Health Initiatives

Public health initiatives, such as overdose prevention education and community-based harm reduction programs, also contribute to the market growth. The integration of naloxone education in opioid prescribing practices and the inclusion of naloxone in community-based programs further boost demand[4].

Geographical Analysis

North America

North America, particularly the United States, represents the largest market for naloxone, expected to hold 43.8% of the market share in 2024. The region's growing epidemic of opioid abuse and rising mortality rates have led to increased government focus and policy changes to expand access to naloxone. Many states and municipalities recommend or require naloxone to be co-prescribed with opioid prescriptions, driving up demand[1].

Distribution and Accessibility

Prescription vs. Nonprescription Status

There is ongoing discussion about transitioning naloxone from prescription to nonprescription status to decrease disparities in access. Former FDA Commissioners have emphasized the importance of increasing naloxone availability, suggesting that a nonprescription status could yield economic benefits and increase overall sales[3].

Cost and Insurance Coverage

The cost and insurance coverage of naloxone play significant roles in its accessibility. Many private and public healthcare plans provide coverage for naloxone, making it affordable for users. However, the economic implications of a switch to nonprescription status are complex, as it may affect payor decision-making and consumer out-of-pocket costs[3].

Financial Implications

Revenue Projections

The naloxone spray market, a segment of the broader naloxone market, is expected to grow exponentially. From $540.68 billion in 2023 to $668.6 billion in 2024, the market is projected to reach $1,592.93 billion by 2028, with a CAGR of 24.2% during the forecast period[4].

Economic Benefits

Transitioning naloxone to nonprescription status is expected to yield economic benefits to both consumers and the healthcare system. This shift could increase overall sales and reduce healthcare costs associated with opioid overdoses[3].

Competitive Landscape

The naloxone hydrochloride market is characterized by a competitive landscape with several key players. Leading pharmaceutical manufacturers have a well-established presence, particularly in the U.S., with extensive distribution networks ensuring wide availability of branded and generic naloxone products[1].

Market Trends

Intranasal Formulations

The adoption of intranasal naloxone formulations is a significant trend. These user-friendly devices are easier to administer, especially in emergency situations, and are gaining popularity due to their ease of use and effectiveness[4].

Integration in Opioid Prescribing Practices

The integration of naloxone education in opioid prescribing practices is another key trend. This approach ensures that healthcare providers are equipped to prescribe naloxone alongside opioid analgesics, further increasing its availability and use[4].

Challenges and Barriers

Cost Barriers

Despite favorable policies, cost barriers remain a significant challenge. Laws addressing liability costs alone have shown small and insignificant effects on naloxone distribution, highlighting the need to address price barriers to increase access, especially for populations facing high out-of-pocket costs[5].

Future Outlook

The future of the naloxone hydrochloride market looks promising, driven by supportive government initiatives, increasing awareness, and advancements in drug development. As the opioid crisis continues to be a public health concern, the demand for naloxone is expected to rise, driving market growth and expansion.

Key Takeaways

The naloxone market is valued at USD 1,341.5 million in 2024 and is expected to reach USD 2,683.9 million by 2031.
Increasing opioid overdose cases and favorable government policies are key drivers of market growth.
North America, particularly the U.S., holds the largest market share.
Transitioning naloxone to nonprescription status could increase accessibility and economic benefits.
Intranasal formulations and integration in opioid prescribing practices are significant market trends.
Cost barriers remain a challenge that needs to be addressed.

FAQs

Q: What is the current market size of the naloxone hydrochloride market? A: The naloxone market is valued at USD 1,341.5 million in 2024[1].

Q: What is the projected CAGR for the naloxone market from 2024 to 2031? A: The naloxone market is expected to grow at a CAGR of 10.4% from 2024 to 2031[1].

Q: Which region holds the largest market share for naloxone? A: North America, particularly the United States, holds the largest market share for naloxone, expected to be 43.8% in 2024[1].

Q: What are the main drivers of the naloxone market growth? A: The main drivers include increasing opioid overdose cases, favorable government policies, and public health initiatives[1][3][4].

Q: What are the potential economic benefits of transitioning naloxone to nonprescription status? A: Transitioning naloxone to nonprescription status could yield economic benefits to both consumers and the healthcare system, including increased overall sales and reduced healthcare costs[3].

Sources

Coherent Market Insights - Naloxone Market Size & Share Analysis - Industry Research Report
Biospace - Naloxone Hydrochloride Market Progression Status, Revenue Expectation to 2029 Research Report
Reagan-Udall Foundation - SUMMARY REPORT - Naloxone Report FINAL 3.8.23
The Business Research Company - Naloxone Spray Global Market Report 2024
PMC - Investigating the complexity of naloxone distribution: Which policies increase access?

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