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Last Updated: January 4, 2025

DEZOCINE - Generic Drug Details


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What are the generic sources for dezocine and what is the scope of patent protection?

Dezocine is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for dezocine.

Summary for DEZOCINE
Recent Clinical Trials for DEZOCINE

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

SponsorPhase
SanQing JinN/A
Xijing HospitalPhase 4
Qiang FuPhase 4

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Anatomical Therapeutic Chemical (ATC) Classes for DEZOCINE

US Patents and Regulatory Information for DEZOCINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-003 Dec 29, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-002 Dec 29, 1989 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-001 Dec 29, 1989 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

Expired US Patents for DEZOCINE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-001 Dec 29, 1989 4,605,671 ⤷  Subscribe
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-002 Dec 29, 1989 4,605,671 ⤷  Subscribe
Astrazeneca DALGAN dezocine INJECTABLE;INJECTION 019082-003 Dec 29, 1989 4,605,671 ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

DEZOCINE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory of Dezocine

Introduction

Dezocine, known by its brand name Dalgan, is an opioid analgesic that has had a complex and varied history in the global pharmaceutical market. Here, we will delve into the market dynamics and financial trajectory of dezocine, highlighting its current status, usage, and future prospects.

Historical Context

Dezocine was first synthesized in 1970 and patented by American Home Products Corp. in 1978. It was approved by the U.S. FDA in 1986 for use as a post-operative analgesic. However, its distribution in the United States was discontinued in 2011 for reasons that were not publicly disclosed[2].

Current Market Status

Despite its discontinuation in the U.S., dezocine has found significant traction in other markets, particularly in China. In China, dezocine is one of the most widely used analgesics, making up over 45% of the opioid analgesic market. This widespread use is due to its efficacy in managing moderate to severe pain, especially in perioperative settings[1].

Market Drivers

Several factors contribute to the ongoing demand for dezocine:

Efficacy and Safety Profile

Dezocine is known for its potent analgesic effects, comparable or even superior to those of morphine, codeine, and pethidine. It has a reduced potential for addiction and fewer adverse effects, such as respiratory depression, compared to full opioid agonists. This profile makes it an attractive option for pain management, especially in regions where opioid addiction is a significant concern[1][2].

Expanding Use Cases

Beyond perioperative pain, dezocine is being explored for other pain management applications, including cancer pain and neuropathic pain. Its effectiveness in these areas, coupled with its lower side effect profile, is driving interest and adoption[1].

Anticancer Properties

Recent studies have shown that dezocine may have anticancer effects, particularly in triple-negative breast cancer (TNBC). This potential as an adjuvant treatment could further expand its market[5].

Financial Trajectory

Market Size and Growth

The global opioids market, which includes dezocine, was valued at US$ 27.28 billion in 2022 and is expected to grow at a CAGR of 4.54% to reach US$ 37.24 billion by 2029. While dezocine is not the dominant player in this market, its specific segment is projected to experience substantial growth. The global dezocine market itself is forecasted to grow at a CAGR of 5% from 2024 to 2032[3][4].

Regional Insights

The market for dezocine is particularly strong in China, where it is widely used. The Asia Pacific region, including China, is a significant contributor to the global opioids market, driven by growing healthcare needs and increasing access to pain therapeutics[3].

Challenges and Opportunities

Despite its growth potential, the market for dezocine faces challenges such as formulation issues and the need for alternative routes of administration. Currently available only as an intravenous or intramuscular solution, efforts are underway to develop intranasal formulations to overcome these limitations[1].

Future Prospects

Expanding Applications

The potential for dezocine to treat opioid use disorder (OUD) and its anticancer properties are significant areas of future growth. Studies have shown that dezocine can alleviate morphine withdrawal symptoms and may offer a better alternative to methadone or buprenorphine for OUD treatment[1].

Regulatory and Market Dynamics

The ongoing opioid crisis and regulatory shifts towards safer, abuse-deterrent formulations are likely to influence the market dynamics of dezocine. As health authorities and regulatory bodies seek safer alternatives, dezocine's unique profile could position it favorably in the market[3].

Key Takeaways

  • Widespread Use in China: Dezocine is a leading opioid analgesic in China, making up over 45% of the opioid analgesic market.
  • Efficacy and Safety: It offers potent analgesia with reduced addiction potential and fewer adverse effects compared to other opioids.
  • Expanding Use Cases: Beyond perioperative pain, dezocine is being explored for cancer pain, neuropathic pain, and OUD treatment.
  • Anticancer Properties: Recent studies suggest dezocine may have anticancer effects, particularly in TNBC.
  • Financial Growth: The global dezocine market is projected to grow at a CAGR of 5% from 2024 to 2032.
  • Challenges and Opportunities: Formulation issues and the need for alternative administration routes are key challenges, but also present opportunities for innovation.

FAQs

What is the current status of dezocine in the U.S. market?

Dezocine was discontinued in the United States in 2011 and is no longer commercially available or prescribed in the U.S.[2].

Why is dezocine widely used in China?

Dezocine is widely used in China due to its efficacy in managing moderate to severe pain, particularly in perioperative settings, and its reduced potential for addiction[1].

What are the potential new applications of dezocine?

Dezocine is being explored for treating cancer pain, neuropathic pain, and opioid use disorder (OUD), as well as its potential anticancer effects[1][5].

What are the challenges facing the expansion of dezocine?

Formulation issues and the need for alternative routes of administration are significant challenges. Currently, dezocine is only available as an intravenous or intramuscular solution[1].

How is the global market for dezocine expected to grow?

The global dezocine market is projected to grow at a CAGR of 5% from 2024 to 2032, driven by its expanding use cases and favorable safety profile[4].

Sources

  1. Dezocine: A Totally Different Opioid - Transl Perioper & Pain Med 2022; 9 (1)[1].
  2. Dezocine - Wikipedia[2].
  3. Opioids Drugs Market- Global Industry Analysis and Forecast (2023-2029) - Maximise Market Research[3].
  4. Global Dezocine Market Size, Revenue, and Forecast | [2024- 2032] - Southeast News Channel Nebraska[4].
  5. Dezocine, An Opioid Analgesic, Exerts Antitumor Effects in Triple-Negative Breast Cancer - Frontiers in Pharmacology[5].

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