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Last Updated: December 22, 2024

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Drug Patent Profile


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

Buprenorphine Hydrochloride And Naloxone Hydrochloride is a drug marketed by Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Teva Pharms Usa, and Wes Pharma Inc. and is included in eighteen NDAs.

The generic ingredient in BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Buprenorphine Hydrochloride And Naloxone Hydrochloride

A generic version of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE was approved as buprenorphine hydrochloride; naloxone hydrochloride by ACTAVIS ELIZABETH on February 22nd, 2013.

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Summary for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Drug patent expirations by year for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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

SponsorPhase
Cure Addiction NowPhase 3
Johns Hopkins UniversityPhase 3
Bicycle HealthPhase 4

See all BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE clinical trials

Pharmacology for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 207000-002 Dec 13, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Lannett Co Inc BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 205022-002 Sep 19, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Sun Pharm BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 201633-001 Aug 5, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Rhodes Pharms BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 205601-001 Mar 30, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alvogen BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL, SUBLINGUAL 205954-001 Jan 24, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Alkem Labs Ltd BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 214930-002 Jun 15, 2021 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

BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Buprenorphine Hydrochloride and Naloxone Hydrochloride

Market Size and Growth Projections

The market for buprenorphine and naloxone, key components in the treatment of opioid use disorder (OUD), is poised for significant growth. As of 2024, the market size is estimated to be USD 4.73 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.23% to reach USD 5.82 billion by 2029[1].

Driving Factors

Several factors are driving the growth of this market:

  • Increasing Substance Use Disorders: The global prevalence of opioid use disorders is a major driver. For instance, over 16 million people worldwide and more than 2.1 million people in the United States are affected by opioid use disorders each year[1].
  • Advantages of Buprenorphine and Naloxone: These medications offer effective treatment for OUD and acute and chronic pain disorders, making them a preferred choice among healthcare providers.
  • Government Initiatives: Initiatives by regional governments, such as the expansion of access to treatment for OUD in the United States through telehealth, are expected to boost market growth[1].

Regional Market Analysis

North America

North America holds a significant share in the global buprenorphine and naloxone market. This is attributed to the high prevalence of substance use disorders, acute and chronic pain disorders, and the presence of prominent players in the region. Government initiatives to manage opioid dependence, such as those proposed by the Substance Abuse and Mental Health Services Administration (SAMHSA), further support market growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market during the forecast period. This growth is driven by increasing awareness of OUD treatment, expanding healthcare infrastructure, and rising government investments in healthcare[1].

Market Segments

Generics Segment

The generics segment is projected to show significant growth due to factors such as cost-effectiveness, patent expirations, and the increasing need for affordable treatment options. Generic versions of buprenorphine and naloxone offer similar efficacy at lower prices, making them more accessible to patients and healthcare systems[1].

Branded vs. Generic

The expiration of patents on branded medications allows generic manufacturers to enter the market, increasing competition and driving growth in the generics segment. This shift is particularly beneficial in regions where affordability is a key concern[1].

Price Elasticity and Demand

Research indicates that the demand for buprenorphine/naloxone is generally price inelastic, meaning that changes in price do not significantly affect demand. However, certain subgroups, such as those aged 45-64 years, residents of rural areas, and those in the South, show a greater responsiveness to price changes. For example, a doubling of price was associated with a decrease in prescription fills by 3.0% to 5.8% in these subgroups[2].

Competitive Landscape

The market is moderately concentrated with several key players, including Indivior PLC, Viatris Inc. (Mylan Inc.), Sandoz AG, Dr. Reddy's Laboratories Ltd., and Hikma Pharmaceuticals PLC. These companies are working towards increasing the production of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets, as well as exploring other formulations like naloxone nasal sprays for emergency treatment of opioid overdose[1][3].

Innovations and Formulations

Subcutaneous Depot Formulations

Recent clinical trials have compared the efficacy of weekly and monthly subcutaneous buprenorphine depot formulations with daily sublingual buprenorphine-naloxone combinations. These studies suggest that the subcutaneous formulations are noninferior in terms of the proportion of urine samples negative for illicit opioids and response rates among treatment-seeking adults with moderate-to-severe OUD[5].

Naloxone Nasal Sprays

The use of naloxone nasal sprays as part of harm reduction therapy for emergency treatment of suspected or known opioid overdose is also gaining traction. This innovation is expected to further expand the market by providing an immediate and effective treatment option[3].

Financial Implications

The growing demand for buprenorphine and naloxone, coupled with government initiatives and the expansion of generic options, is expected to drive substantial financial growth in the market. The increasing prevalence of OUD and the need for effective treatment solutions will continue to propel market revenues.

Key Takeaways

  • The buprenorphine and naloxone market is projected to grow from USD 4.73 billion in 2024 to USD 5.82 billion by 2029.
  • North America holds a significant market share, while the Asia Pacific region is expected to be the fastest-growing.
  • The generics segment is expected to show significant growth due to cost-effectiveness and patent expirations.
  • Government initiatives and innovations in formulations are key drivers of market growth.
  • The demand for buprenorphine/naloxone is generally price inelastic, but certain subgroups show responsiveness to price changes.

Frequently Asked Questions (FAQs)

1. What is the current market size of the buprenorphine and naloxone market?

The buprenorphine and naloxone market size is expected to reach USD 4.73 billion in 2024[1].

2. Which region is expected to be the fastest-growing in the buprenorphine and naloxone market?

The Asia Pacific region is expected to be the fastest-growing market during the forecast period[1].

3. What are the key drivers of the buprenorphine and naloxone market?

Key drivers include increasing substance use disorders, the advantages of using buprenorphine and naloxone, and rising government initiatives to combat opioid dependence[1].

4. How does the generics segment impact the buprenorphine and naloxone market?

The generics segment is expected to show significant growth due to cost-effectiveness, patent expirations, and the increasing need for affordable treatment options[1].

5. Are weekly and monthly subcutaneous buprenorphine depot formulations effective compared to daily sublingual buprenorphine-naloxone combinations?

Yes, clinical trials suggest that these subcutaneous formulations are noninferior in terms of efficacy and response rates among treatment-seeking adults with moderate-to-severe OUD[5].

Sources:

  1. Mordor Intelligence: Buprenorphine And Naloxone Market Size & Share Analysis
  2. PubMed: Price elasticity of demand for buprenorphine/naloxone prescriptions
  3. Transparency Market Research: Opioid Use Disorders Market Size, Trends, Outlook 2034
  4. Grand View Research: Naltrexone And Buprenorphine Market Size Report, 2030
  5. JAMA Internal Medicine: Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical Trial

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