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Last Updated: December 22, 2024

NALOXONE Drug Patent Profile


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

Naloxone is a drug marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd. and is included in seventy-five NDAs. There are eighteen patents protecting this drug.

The generic ingredient in NALOXONE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

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Summary for NALOXONE
Drug patent expirations by year for NALOXONE
Drug Prices for NALOXONE

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Recent Clinical Trials for NALOXONE

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SponsorPhase
Murdoch Childrens Research InstitutePhase 4
Cure Addiction NowPhase 3
Johns Hopkins UniversityPhase 3

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Pharmacology for NALOXONE
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for NALOXONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal NALOXONE HYDROCHLORIDE naloxone hydrochloride SPRAY, METERED;NASAL 217992-001 Apr 23, 2024 OTC No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Igi Labs Inc NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072083-001 Apr 11, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070171-001 Sep 24, 1986 DISCN 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

NALOXONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naloxone

Introduction

Naloxone, an opioid antagonist, has become a critical component in the fight against the opioid epidemic. The market for naloxone is driven by several key factors, including the increasing prevalence of opioid overdoses, government initiatives, and advancements in delivery methods. Here, we delve into the market dynamics and financial trajectory of naloxone.

The Opioid Overdose Epidemic

The opioid crisis in the U.S. and globally has reached alarming levels, with more than 130 people in America dying each day from opioid overdoses. This epidemic is a primary driver for the growth of the naloxone market. Opioid addiction affects over 25 million people worldwide, with the U.S. having the largest number of substance addicts[3][4].

Market Size and Growth

The U.S. naloxone market is estimated to be valued at USD 550.4 million in 2024 and is projected to reach USD 1,086.1 million by 2031, exhibiting a compound annual growth rate (CAGR) of 10.2% from 2024 to 2031[1]. Globally, the naloxone market is expected to grow at a CAGR of 10.1% during the forecast period of 2022-2030[3].

Key Drivers of Market Growth

Increasing Prevalence of Opioid Overdoses

The rising incidence of opioid abuse disorders and overdose deaths is a significant driver for the naloxone market. The urgent need for better treatment options and the growing awareness about overdose emergencies are boosting the adoption of naloxone[1][3][4].

Government Initiatives

Government policies and initiatives aimed at combating the opioid epidemic are crucial for market growth. For instance, the U.S. Department of Health and Human Services (HHS) has allocated significant funds to support state and local initiatives, and the U.S. Surgeon General's advisory has advocated for expanded naloxone access[4].

Advancements in Delivery Forms

The availability of various delivery forms such as auto-injectors (e.g., Evzio) and nasal sprays (e.g., Narcan) has enhanced the market. These formulations make it easier for non-medical personnel to administer naloxone in emergency situations, contributing to the market's growth[1][4].

Market Segmentation

Formulation/Route of Administration

The naloxone market is segmented into parenteral, intranasal, and sublingual formulations. The parenteral segment has historically dominated the market due to its long-standing use in hospital settings and by emergency medical services (EMS) personnel. However, intranasal formulations are gaining traction due to their ease of use and effectiveness[3][4].

Dosage

The market is also segmented by dosage, with strengths such as 0.4 mg/ml, 1 mg/ml, and 2.0 mg/ml. The 2.0 mg/ml strength is experiencing rapid growth, particularly with the increasing adoption of intranasal naloxone formulations[3].

Sales Channel

Naloxone is distributed through various channels, including hospitals, outpatient retail pharmacies, online pharmacies, and others. The expansion of distribution channels has improved access to naloxone, contributing to market growth[3].

Financial Trajectory

Cost-Effectiveness

Studies have shown that naloxone distribution is cost-effective, particularly when targeted at high-risk populations. For instance, distributing intranasal naloxone to high-risk prescription opioid patients can prevent additional overdose deaths at an incremental cost-effectiveness ratio (ICER) of $56,699 per quality-adjusted life year (QALY)[2].

Out-of-Pocket Costs

The financial accessibility of naloxone varies significantly. While the mean out-of-pocket (OOP) cost of naloxone decreased by 26% among insured patients between 2014 and 2018, it increased by 506% among uninsured patients. Certain brands, such as Evzio, have seen dramatic increases in OOP costs for uninsured patients, highlighting a significant financial barrier to access[5].

Market Projections

The global naloxone market is projected to reach USD 2,478.6 million by 2032, growing at a CAGR of 9.7% from 2024 to 2032. This growth is fueled by the escalating opioid addiction crisis and the increasing demand for naloxone as a life-saving medication[4].

Key Players and Strategies

Prominent players in the naloxone market include Amneal Pharmaceuticals Inc., Kaleo Inc., Adapt Pharma (now part of Emergent BioSolutions), Pfizer Inc., and others. These companies are focusing on expanding their product portfolios, improving distribution channels, and collaborating with government and healthcare organizations to enhance market presence[4].

Regional Market Dynamics

The U.S. holds the largest market share due to the high prevalence of opioid addiction. However, the Asia Pacific region is observed to be the most attractive for future growth due to a swift increase in the uptake of medicines to prevent overdose deaths[3].

Conclusion

The naloxone market is driven by the urgent need to address the opioid epidemic, government initiatives, and advancements in delivery forms. With a projected CAGR of 10.2% in the U.S. and 10.1% globally, the market is expected to grow significantly. However, financial barriers, particularly for uninsured patients, remain a challenge that needs to be addressed.

Key Takeaways

  • The U.S. naloxone market is expected to reach USD 1,086.1 million by 2031.
  • The global naloxone market is projected to grow at a CAGR of 10.1% from 2022 to 2030.
  • Increasing prevalence of opioid overdoses and government initiatives are key drivers.
  • Advancements in delivery forms, such as intranasal sprays, are boosting market growth.
  • Financial barriers, especially for uninsured patients, need to be addressed.

FAQs

Q: What is the primary driver for the growth of the naloxone market? A: The primary driver is the increasing prevalence of opioid overdoses and the urgent need for better treatment options.

Q: How is the global naloxone market expected to grow? A: The global naloxone market is expected to grow at a CAGR of 10.1% from 2022 to 2030.

Q: What are the different formulations of naloxone available? A: Naloxone is available in parenteral, intranasal, and sublingual formulations.

Q: How do out-of-pocket costs for naloxone vary between insured and uninsured patients? A: Out-of-pocket costs for naloxone decreased by 26% among insured patients but increased by 506% among uninsured patients between 2014 and 2018.

Q: Which region is expected to be the most attractive for the naloxone market in the future? A: The Asia Pacific region is expected to be the most attractive due to a swift increase in the uptake of medicines to prevent overdose deaths.

Sources

  1. Coherent Market Insights: US Naloxone Market Size and Trends.
  2. NCBI: An economic evaluation of community pharmacy–dispensed naloxone.
  3. GlobeNewswire: Insights on the Naloxone Global Market to 2030.
  4. GlobeNewswire: Naloxone Market To Reach USD 2,478.6 Million By 2032.
  5. PubMed: Trends in Out-of-Pocket Costs for Naloxone by Drug Brand and Payer.

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