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Last Updated: December 21, 2024

BUPRENEX Drug Patent Profile


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When do Buprenex patents expire, and when can generic versions of Buprenex launch?

Buprenex is a drug marketed by Indivior and is included in one NDA.

The generic ingredient in BUPRENEX is buprenorphine hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride profile page.

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Summary for BUPRENEX
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 18
Clinical Trials: 8
Patent Applications: 5,049
Drug Prices: Drug price information for BUPRENEX
What excipients (inactive ingredients) are in BUPRENEX?BUPRENEX excipients list
DailyMed Link:BUPRENEX at DailyMed
Drug patent expirations by year for BUPRENEX
Drug Prices for BUPRENEX

See drug prices for BUPRENEX

Recent Clinical Trials for BUPRENEX

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

SponsorPhase
Medical College of WisconsinPhase 2
United States Department of DefensePhase 1/Phase 2
Yale UniversityPhase 1/Phase 2

See all BUPRENEX clinical trials

US Patents and Regulatory Information for BUPRENEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Indivior BUPRENEX buprenorphine hydrochloride INJECTABLE;INJECTION 018401-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

BUPRENEX Market Analysis and Financial Projection Experimental

Buprenorphine Market Dynamics and Financial Trajectory

Introduction to Buprenorphine

Buprenorphine, a mixed opioid agonist-antagonist, is widely used for managing acute and chronic pain, as well as treating opioid dependence. Its efficacy and safety have made it a crucial component in the fight against the opioid epidemic.

Market Size and Growth Projections

The global buprenorphine market is experiencing significant growth driven by increasing demand for opioid dependence treatment and advancements in formulation technologies.

  • Current Market Size: In 2023, the global buprenorphine market was valued at approximately USD 5.51 billion[1][3][4].
  • Future Projections: The market is expected to reach USD 17.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 15.20%[1].
  • Alternative Projections: Other estimates suggest the market could reach USD 9.9 billion by 2028, growing at a CAGR of 8.2% from 2023 to 2028[3].

Segmentation of the Market

The buprenorphine market is segmented based on several key factors:

By Application

  • Analgesic: Used for managing acute and chronic pain.
  • Opioid Antagonist: Used in the treatment of opioid dependence[5].

By Route of Administration

  • Injectables: Commonly used in clinical settings.
  • Sublingual: Tablets or films placed under the tongue.
  • Transdermal Patches: Patches applied to the skin for slow release[1][3].

By Distribution Channel

  • Hospital Pharmacies: Primary distribution point for inpatient care.
  • Retail Pharmacies: Common outlet for outpatient prescriptions.
  • Online Pharmacies: Growing segment due to convenience and accessibility[1].

Regional Proliferation

The market is spread across various regions, each with its own growth prospects:

  • North America: A significant market due to the high prevalence of opioid use disorder.
  • Europe: Steady growth driven by regulatory support and increasing awareness.
  • Asia Pacific: Rapidly growing due to a burgeoning population and evolving healthcare infrastructure[4].

Cost-Effectiveness and Economic Evaluation

Economic evaluations highlight the cost-effectiveness of different buprenorphine formulations:

  • Transmucosal Buprenorphine: This formulation has been found to be more cost-effective compared to extended-release buprenorphine, with an incremental cost-effectiveness ratio (ICER) of $19,740 per quality-adjusted life year (QALY)[2].
  • Extended-Release Buprenorphine: While it offers convenience, it is less cost-effective and has lower retention rates compared to transmucosal buprenorphine[2].

Regulatory Framework and Reimbursement

The regulatory environment plays a crucial role in the market's growth:

  • Standards and Compliances: Strict regulations ensure the safety and efficacy of buprenorphine products.
  • Reimbursement Framework: Favorable reimbursement policies in many countries support the adoption of buprenorphine treatments[1].

Technological Advancements

Advancements in formulation technologies have significantly impacted the market:

  • Novel Delivery Systems: New delivery systems such as sublingual films and transdermal patches enhance patient convenience and compliance[4].

Competitive Landscape

The market is competitive with several key players:

  • Prominent Players: Companies like Resonance-labs, Unichemlabs, Noramco, Siegfried, Faranshimi, Johnson Matthey, Rusan Pharma, Mallinckrodt, Sanofi, Sun Pharma, and others are actively involved in the market[5].

Industry Value Chain Analysis

The value chain includes various stages from production to distribution:

  • Cost Analysis Breakdown: The cost includes pharmaceutical production costs, healthcare utilization costs, and treatment retention costs[1][2].

Public Health Impact

Buprenorphine has a significant impact on public health, particularly in the context of the opioid epidemic:

  • Opioid Use Disorder: Between 1999 and 2020, the US Centers for Disease Control and Prevention estimated that drug use resulted in approximately 494,492 deaths annually, with drug use disorders accounting for around 128,083 deaths each year[3].
"Buprenorphine, an FDA-approved medication, is utilized for various purposes such as managing acute and chronic pain as well as treating opioid dependence. It is part of agonist substitution treatment, a method that involves substituting a stronger opioid agonist (like heroin) with a substance such as buprenorphine or methadone for addiction treatment."[3]

Key Challenges and Opportunities

  • Challenges: Variations in regulatory frameworks, cultural perceptions, and economic disparities across countries pose challenges for market penetration and patient outreach[4].
  • Opportunities: Increasing research investments, regulatory support, and growing recognition of buprenorphine's efficacy and safety present significant opportunities for market growth[4].

Conclusion

The buprenorphine market is poised for substantial growth driven by increasing demand for opioid dependence treatment, advancements in formulation technologies, and favorable regulatory environments. The market's financial trajectory indicates a significant increase in value over the forecast period, making it a promising sector for investment and innovation.

Key Takeaways

  • The global buprenorphine market is expected to grow significantly, reaching USD 17.1 billion by 2031.
  • Transmucosal buprenorphine is more cost-effective than extended-release buprenorphine.
  • Technological advancements in delivery systems are enhancing patient convenience and compliance.
  • The market is driven by the growing need for opioid dependence treatment and favorable regulatory support.
  • Key players are investing heavily in research and development to capture market share.

FAQs

Q: What is the current market size of the global buprenorphine market? A: The global buprenorphine market was valued at approximately USD 5.51 billion in 2023[1].

Q: What is the projected growth rate of the buprenorphine market? A: The market is expected to grow at a CAGR of 15.20% from 2023 to 2031[1].

Q: Which regions are expected to drive the growth of the buprenorphine market? A: North America, Europe, and the Asia Pacific are expected to be key drivers of market growth[4].

Q: What are the primary applications of buprenorphine? A: Buprenorphine is used as an analgesic and for treating opioid dependence[5].

Q: Which formulation of buprenorphine is more cost-effective? A: Transmucosal buprenorphine is more cost-effective compared to extended-release buprenorphine[2].

Sources

  1. FutureWise Research: Buprenorphine Market Overview.
  2. JAMA Network Open: Extended-Release Buprenorphine for Persons With Opioid Use Disorder.
  3. Market Data Forecast: Buprenorphine Market Worth USD 9.9 Bn By 2028.
  4. Reanin: Buprenorphine Market | Growth | Share | Size | Trends and Forecast.
  5. Vantage Market Research: Buprenorphine Hydrochloride Market: Trends & Size 2032.

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