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Last Updated: December 22, 2024

BUPRENORPHINE Drug Patent Profile


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Which patents cover Buprenorphine, and what generic alternatives are available?

Buprenorphine is a drug marketed by Alvogen, Amneal, Difgen Pharms, Mylan Tech Viatris, Watson Labs Teva, Am Regent, Endo Operations, Hikma, Hospira, Actavis Elizabeth, Barr, Ethypharm, Norvium Bioscience, Rhodes Pharms, Rubicon, Sun Pharm, Dr Reddys Labs Sa, Mylan Technologies, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Teva Pharms Usa, and Wes Pharma Inc. and is included in thirty-six NDAs.

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

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Drug patent expirations by year for BUPRENORPHINE
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Recent Clinical Trials for BUPRENORPHINE

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

SponsorPhase
Brigham and Women's HospitalPhase 1
Icahn School of Medicine at Mount SinaiPhase 4
Cure Addiction NowPhase 3

See all BUPRENORPHINE clinical trials

Pharmacology for BUPRENORPHINE
Drug ClassPartial Opioid Agonist
Mechanism of ActionPartial Opioid Agonists
Medical Subject Heading (MeSH) Categories for BUPRENORPHINE
Paragraph IV (Patent) Challenges for BUPRENORPHINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BUTRANS Transdermal System buprenorphine 15 mcg/hr 021306 1 2013-12-16
BUTRANS Transdermal System buprenorphine 5 mcg/hr 10 mcg/hr 20 mcg/hr 021306 1 2013-06-06

US Patents and Regulatory Information for BUPRENORPHINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal Pharms BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 203136-002 Feb 22, 2013 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ethypharm BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090622-001 Sep 24, 2010 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alvogen BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride FILM;BUCCAL 211594-007 Aug 3, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-002 Aug 5, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rubicon BUPRENORPHINE HYDROCHLORIDE buprenorphine hydrochloride TABLET;SUBLINGUAL 090279-001 Jun 10, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Sa BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205806-001 Jun 14, 2018 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

EU/EMA Drug Approvals for BUPRENORPHINE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
L. Molteni & C. dei Fratelli Alitti Società di Esercizio S.p.A. Sixmo buprenorphine EMEA/H/C/004743
Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Authorised no no no 2019-06-19
Camurus AB Buvidal buprenorphine EMEA/H/C/004651
Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.
Authorised no no no 2018-11-20
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

BUPRENORPHINE Market Analysis and Financial Projection Experimental

Buprenorphine Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The buprenorphine market is poised for significant growth in the coming years. As of 2023, the global buprenorphine market was valued at approximately USD 5.44 billion to USD 5.52 billion, depending on the source[1][3][4].

By 2036, the market is expected to exceed USD 31.27 billion, with a compounded annual growth rate (CAGR) of over 14.4% to 14.9% during the forecast period from 2024 to 2036[1][3][4].

Growth Drivers

Several factors are driving the growth of the buprenorphine market:

Increasing Prevalence of Opioid Use Disorder

The escalating issue of opioid addiction globally is a major driver. According to various studies, a significant percentage of patients prescribed opioids for chronic pain misuse them, leading to opioid use disorder (OUD). For instance, in North America, 21 to 29 percent of patients misuse opioids prescribed for chronic pain, with 8-12% developing an OUD[1].

Regulatory Approvals

Recent approvals by regulatory authorities, such as the U.S. Food and Drug Administration (FDA), for buprenorphine treatments, including the approval of Brixadi (buprenorphine) extended-release injection, are boosting market growth. These approvals expand the treatment options available for moderate to severe OUD[3][4].

Government Investments in Healthcare

Increased government investments in healthcare, particularly in developed nations, are also contributing to the market's expansion. These investments enhance the accessibility and affordability of buprenorphine treatments[1].

Growing Demand for Effective Pain Management

The rising incidence of chronic pain disorders and cancer further drives the demand for buprenorphine. According to the World Health Organization (WHO), cancer is a leading cause of deaths worldwide, accounting for about 10 million deaths in 2020[1].

Market Segmentation

The buprenorphine market is segmented based on several criteria:

Route of Administration

The market is segmented into sublingual, transdermal, and buccal routes of administration. The sublingual segment is expected to hold the largest share due to the increasing availability of buprenorphine drugs in various dosages and the rapid drug absorption, first-pass metabolism, and quick onset of action associated with this route[1].

Geographical Regions

North America is projected to account for the largest revenue share by 2036, driven by the strong presence of market players and the high prevalence of opioid dependency in the region. Europe and the Asia Pacific are also expected to contribute significantly to the market growth due to new medical product launches and growing awareness about buprenorphine's health benefits[1][3].

Cost-Effectiveness and Economic Evaluation

Economic evaluations highlight the cost-effectiveness of buprenorphine treatments:

Transmucosal vs. Extended-Release Buprenorphine

Studies using state transition models have shown that treatment with transmucosal buprenorphine is generally more cost-effective than extended-release buprenorphine. For instance, transmucosal buprenorphine yielded an incremental cost-effectiveness ratio (ICER) of $19,740 per quality-adjusted life year (QALY) compared to no medication treatment, while extended-release buprenorphine was less effective and more costly[2].

Impact of Treatment Duration and Capacity

Interventions that increase buprenorphine treatment duration and expand treatment capacity, such as contingency management and telehealth, are associated with better outcomes and higher cost-effectiveness. These strategies can avert a significant number of opioid overdose deaths and are preferred at various willingness-to-pay thresholds[5].

Challenges and Opportunities

While the market is growing, there are challenges and opportunities to consider:

Challenges

  • High costs associated with extended-release formulations can be a barrier.
  • Lower retention rates for extended-release buprenorphine compared to transmucosal buprenorphine (29% vs. 47% at 6 months) can impact treatment effectiveness[2].

Opportunities

  • The increasing dependency on painkillers and the subsequent rise in opioid addiction present lucrative opportunities for buprenorphine.
  • Growing awareness and regulatory approvals are expected to expand the market further[1][3].

Regional Market Analysis

North America

North America is expected to dominate the market due to the high prevalence of opioid dependency and strong market presence. The region saw a significant increase in buprenorphine prescriptions, from 1.9 million to 4.3 million between 2009 and 2018[3].

Europe and Asia Pacific

Europe is anticipated to acquire a notable share due to new medical product launches, while the Asia Pacific region is expected to witness noteworthy growth driven by a rising patient pool and increasing awareness about buprenorphine's benefits[1].

Key Takeaways

  • The buprenorphine market is expected to grow significantly, driven by the increasing prevalence of opioid use disorder and chronic pain.
  • Regulatory approvals and government investments in healthcare are key drivers.
  • The sublingual route of administration is expected to dominate the market.
  • North America will lead the market, followed by Europe and the Asia Pacific.
  • Cost-effectiveness studies favor transmucosal buprenorphine over extended-release formulations.

FAQs

1. What is the current market size of the buprenorphine market? The global buprenorphine market was valued at approximately USD 5.44 billion to USD 5.52 billion in 2023[1][3][4].

2. What is the projected growth rate of the buprenorphine market? The market is expected to grow at a CAGR of over 14.4% to 14.9% from 2024 to 2036[1][3][4].

3. Which region is expected to dominate the buprenorphine market? North America is expected to account for the largest revenue share by 2036 due to the strong presence of market players and high prevalence of opioid dependency[1][3].

4. What are the main drivers of the buprenorphine market growth? Key drivers include the increasing prevalence of opioid use disorder, regulatory approvals, government investments in healthcare, and growing demand for effective pain management[1][3][4].

5. Which route of administration is expected to hold the largest share in the buprenorphine market? The sublingual route of administration is anticipated to hold the largest share due to its rapid drug absorption and quick onset of action[1].

Citations

  1. Research Nester, "Buprenorphine Market Size & Share, Growth Trends 2036"
  2. JAMA Network, "Extended-Release Buprenorphine for Persons With Opioid Use Disorder"
  3. Coherent Market Insights, "Buprenorphine Market Size, Trends and Forecast to 2030"
  4. Coherent Market Insights, "Buprenorphine Market Size and Trends"
  5. JAMA Health Forum, "Cost-effectiveness of Increasing Buprenorphine Treatment Initiation"

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