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Last Updated: December 22, 2024

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Drug Patent Profile


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When do Naloxone Hydrochloride And Pentazocine Hydrochloride patents expire, and when can generic versions of Naloxone Hydrochloride And Pentazocine Hydrochloride launch?

Naloxone Hydrochloride And Pentazocine Hydrochloride is a drug marketed by Lupin, Sun Pharm Inds Ltd, and Watson Labs. and is included in three NDAs.

The generic ingredient in NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE 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 HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Drug patent expirations by year for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
Recent Clinical Trials for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

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

See all NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE clinical trials

Pharmacology for NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE

US Patents and Regulatory Information for NALOXONE HYDROCHLORIDE AND 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 ⤷  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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Naloxone Hydrochloride and Pentazocine Hydrochloride

Introduction to Naloxone Hydrochloride and Pentazocine Hydrochloride

Naloxone hydrochloride and pentazocine hydrochloride are crucial medications in the fight against opioid overdoses and pain management. Naloxone hydrochloride is a potent opioid antagonist, while pentazocine hydrochloride is a mixed agonist-antagonist opioid analgesic. Here, we delve into the market dynamics and financial trajectory of these drugs.

Market Dynamics of Naloxone Hydrochloride

Drivers of Growth

  • Increasing Prevalence of Opioid Overdose: The growing number of opioid overdose cases globally is a significant driver for the naloxone hydrochloride market. As the opioid crisis deepens, the demand for naloxone as an emergency treatment has surged[1][4].
  • Rising Investments: Major pharmaceutical companies are increasing their investments in naloxone hydrochloride, which is expected to boost market growth. This includes research and development of new formulations and distribution strategies[1][4].

Challenges and Restraints

  • High Cost and Side Effects: Despite its critical role, the high cost of naloxone hydrochloride and its potential side effects are significant barriers to market growth. The financial burden is particularly pronounced for uninsured patients, who have seen out-of-pocket costs increase dramatically[1][3].
  • Misuse and Abuse: The potential for misuse and abuse of naloxone hydrochloride, especially in combination with other substances, poses a challenge. This has led to the development of formulations like pentazocine and naloxone hydrochloride tablets, designed to curb parenteral misuse[2][5].

Market Dynamics of Pentazocine Hydrochloride

Drivers of Growth

  • Analgesic Efficacy: Pentazocine hydrochloride is a potent analgesic, offering significant pain relief, which drives its demand in the healthcare sector. Its efficacy is comparable to other strong analgesics like codeine[2][5].
  • Combination Therapies: The combination of pentazocine with naloxone hydrochloride in tablets has been designed to prevent misuse by injection, making it a safer option for oral use. This combination is expected to see increased adoption due to its balanced analgesic and antagonist properties[2][5].

Challenges and Restraints

  • Dependence and Withdrawal: Pentazocine hydrochloride can lead to psychological and physical dependence, especially in patients with a history of drug abuse. Abrupt discontinuation can result in severe withdrawal symptoms, which is a significant concern[2][5].
  • Regulatory and Safety Issues: The misuse of pentazocine and naloxone hydrochloride tablets by injection can lead to severe, even lethal, consequences. This necessitates strict regulatory oversight and safety measures, which can impact market growth[2][5].

Financial Trajectory

Naloxone Hydrochloride Market

  • Revenue Growth: The global naloxone hydrochloride market is projected to witness high growth during the forecast period, driven by increasing demand and investments. The market is expected to reach significant revenue by 2031, with a substantial CAGR from 2023 to 2031[1][4].
  • Cost Trends: The out-of-pocket costs for naloxone have been a significant barrier, especially for uninsured patients. Between 2014 and 2018, the mean out-of-pocket cost for naloxone increased by 506% for uninsured patients, while it decreased by 26% for those with insurance[3].

Pentazocine Hydrochloride Market

  • Market Segmentation: The market for pentazocine hydrochloride is segmented based on its combination with naloxone and its application. The presence of naloxone in these tablets prevents the misuse of pentazocine by injection, which is a key factor in its market positioning[2][5].
  • Competitive Landscape: The market for pentazocine and naloxone hydrochloride is moderately competitive, with several key players such as Easton Biopharmaceuticals, Sun Pharmaceutical, and Siegfried. The competitive landscape is expected to intensify with new entrants and ongoing research and development activities[4].

Regional Analysis

  • Global Market: The naloxone hydrochloride and pentazocine hydrochloride markets are analyzed across major regions including North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America. Each region is further sub-segmented by country to provide a detailed market overview[1][4].
  • PEST Analysis: The market dynamics are also influenced by political, economic, social, and technological factors in each region, which are evaluated through PEST analysis to provide a comprehensive understanding of the market environment[1].

Key Players and Market Leaders

  • Major Players: The market is dominated by a handful of key players, including Easton Biopharmaceuticals, Gaobo Jingband Pharmaceutical, Sun Pharmaceutical, and Siegfried. These companies are investing heavily in research and development to enhance their market positions[4].
  • Competitive Strategies: The competitive landscape includes strategies such as mergers and acquisitions, new product developments, and geographical expansions. These strategies are crucial for maintaining market share and driving growth in a highly competitive environment[4].

Future Trends and Developments

  • Technological Advancements: Future trends include the development of new formulations and delivery systems for naloxone and pentazocine hydrochloride. Innovations such as nasal sprays and auto-injectors are expected to improve accessibility and ease of use[1][4].
  • Regulatory Support: Government initiatives and regulatory support, such as standing orders and prescriptive authority laws, are expected to expand access to these medications. However, addressing financial barriers remains a critical challenge[3].

Key Takeaways

  • The naloxone hydrochloride market is driven by the increasing prevalence of opioid overdoses and rising investments by major players.
  • Pentazocine hydrochloride's market is influenced by its analgesic efficacy and the safety features of its combination with naloxone.
  • High costs and potential side effects are significant restraints for both markets.
  • The competitive landscape is moderately competitive with a few key players dominating the market.
  • Future trends include technological advancements and regulatory support to expand access.

Frequently Asked Questions (FAQs)

1. What are the primary drivers of the naloxone hydrochloride market?

The primary drivers include the growing prevalence of opioid overdose and rising investments by major pharmaceutical companies.

2. How does the presence of naloxone affect pentazocine hydrochloride tablets?

The presence of naloxone in pentazocine hydrochloride tablets prevents the misuse of pentazocine by injection, as naloxone neutralizes the effect of pentazocine when administered parenterally.

3. What are the financial barriers to accessing naloxone hydrochloride?

The out-of-pocket costs for naloxone have significantly increased for uninsured patients, posing a substantial financial barrier to access.

4. Which regions are key markets for naloxone hydrochloride and pentazocine hydrochloride?

The key markets include North America, Europe, Asia-Pacific, Middle East and Africa, and South & Central America.

5. How do regulatory initiatives impact the market for these drugs?

Regulatory initiatives such as standing orders and prescriptive authority laws have expanded access to these medications, but addressing financial barriers remains a critical challenge.

Cited Sources:

  1. The Insight Partners. Naloxone Hydrochloride Market Insights and Growth by 2031.
  2. DailyMed. Pentazocine hydrochloride and naloxone hydrochloride tablet.
  3. PubMed. Trends in Out-of-Pocket Costs for Naloxone by Drug Brand and Payer.
  4. BioSpace. Naloxone Hydrochloride Market Progression Status, Revenue Expectation to 2029 Research Report.
  5. FDA. TALWIN Nx CIV pentazocine hydrochloride and naloxone hydrochloride tablet.

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