Buprenorphine hydrochloride; naloxone hydrochloride - Generic Drug Details

What are the generic sources for buprenorphine hydrochloride; naloxone hydrochloride and what is the scope of freedom to operate?

Buprenorphine hydrochloride; naloxone hydrochloride is the generic ingredient in five branded drugs marketed by Bdsi, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Indivior, Teva Pharms Usa, Actavis Elizabeth, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Hikma, Lannett Co Inc, Rhodes Pharms, Specgx Llc, Sun Pharm, Wes Pharma Inc, and Orexo Us Inc, and is included in twenty-three NDAs. There are seventeen patents protecting this compound and nine Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride; naloxone hydrochloride has one hundred and seventy-seven patent family members in thirty-six countries.

Twenty-four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for buprenorphine hydrochloride; naloxone hydrochloride

International Patents:	177
US Patents:	17
Tradenames:	5
Applicants:	18
NDAs:	23
Finished Product Suppliers / Packagers:	24
Clinical Trials:	140
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for buprenorphine hydrochloride; naloxone hydrochloride
DailyMed Link:	buprenorphine hydrochloride; naloxone hydrochloride at DailyMed

Recent Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride

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

Sponsor	Phase
University of North Carolina, Chapel Hill	PHASE4
NYU Langone Health	PHASE4
National Institute on Drug Abuse (NIDA)	PHASE4

See all buprenorphine hydrochloride; naloxone hydrochloride clinical trials

Generic filers with tentative approvals for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 8MG BASE;EQ 2MG BASE	FILM;BUCCAL, SUBLINGUAL
		EQ 0.7MG BASE;EQ 0.18MG BASE	TABLET;SUBLINGUAL
		EQ 2.9MG BASE;EQ 0.71MG BASE	TABLET;SUBLINGUAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for buprenorphine hydrochloride; naloxone hydrochloride

Drug Class	Opioid Antagonist Partial Opioid Agonist
Mechanism of Action	Opioid Antagonists Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for buprenorphine hydrochloride; naloxone hydrochloride

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

N02AE	Oripavine derivatives
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

N07BC	Drugs used in opioid dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	0.7 mg/0.18 mg	204242	1	2017-05-04
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	2.1 mg/0.3 mg and 4.2 mg/0.7 mg	205637	1	2016-11-23
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	2.9 mg/7.1 mg	204242	1	2015-12-21
BUNAVAIL	Buccal Film	buprenorphine hydrochloride; naloxone hydrochloride	6.3 mg/1 mg	205637	1	2015-12-21
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	8.6 mg/2.1 mg and 11.4 mg/2.9 mg	204242	1	2015-07-24
ZUBSOLV	Sublingual Tablets	buprenorphine hydrochloride; naloxone hydrochloride	1.4 mg/0.36 mg and 5.7 mg/1.4 mg	204242	1	2013-10-22
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	12 mg/3 mg	022410	1	2013-05-14
SUBOXONE	Sublingual Film	buprenorphine hydrochloride; naloxone hydrochloride	2 mg/0.5 mg* and 8 mg/2 mg	022410	1	2012-10-15
SUBOXONE	for Injection	buprenorphine hydrochloride; naloxone hydrochloride	500 mg/vial	020733	2	2009-01-26

US Patents and Regulatory Information for buprenorphine hydrochloride; naloxone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	091149-001	Sep 8, 2014		DISCN	No	No
Specgx Llc	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	207000-002	Dec 13, 2017	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	10,946,010		Y
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-004	Dec 11, 2014		RX	Yes	Yes	11,433,066
Alvogen	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	205954-001	Jan 24, 2019	AB	RX	No	No
Rhodes Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205601-001	Mar 30, 2020	AB	RX	No	No

Expired US Patents for buprenorphine hydrochloride; naloxone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015	8,454,996
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-003	Aug 10, 2012	9,931,305
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014	7,579,019
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-003	Jun 6, 2014	6,159,498
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-002	Aug 30, 2010	9,931,305
Indivior	SUBOXONE	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL, SUBLINGUAL	022410-001	Aug 30, 2010	10,285,910

International Patents for buprenorphine hydrochloride; naloxone hydrochloride

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2019118034	СПОСОБ ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА, СРЕДСТВО ТРАНСМУКОЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВА (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ БОЛИ
Singapore	178265
World Intellectual Property Organization (WIPO)	2013041851
Singapore	11201401446R
San Marino	T201500126	Nuova composizione farmaceutica resistente all'abuso per il trattamento di una dipendenza da oppioidi
Slovenia	2054031

Market Dynamics and Financial Trajectory for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Last updated: July 29, 2025

Introduction

The combination of Buprenorphine Hydrochloride and Naloxone Hydrochloride has emerged as a pivotal pharmacotherapy in the management of opioid use disorder (OUD). As opioid addiction escalates globally, this medication—commonly marketed under brand names like Suboxone—serves a dual purpose: reducing withdrawal symptoms and averting misuse. Analyzing the market dynamics and financial trajectory of this combination drug provides insights into future growth, competitive landscapes, regulatory impacts, and investment opportunities.

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Market Overview

Therapeutic Significance

Buprenorphine, a partial opioid agonist, attenuates withdrawal symptoms, while Naloxone, an opioid antagonist, discourages intravenous misuse. This formulation, approved widely across the U.S. since the 2000s, represents a cornerstone in medication-assisted treatment (MAT). According to the Substance Abuse and Mental Health Services Administration (SAMHSA), over 2.5 million Americans require treatment for opioid dependence, with increasing reliance on pharmacotherapies [1].

Market Size and Growth

The global opioid dependence treatment market, encompassing medications like buprenorphine/naloxone, was valued at approximately USD 2.4 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 8-10% through 2030 [2]. North America dominates the market, driven by high opioid misuse prevalence, extensive healthcare infrastructure, and supportive regulatory policies.

Market Segmentation

• By Formulation: Film, tablet, injectable
• By Distribution Channel: Hospitals, specialty clinics, retail pharmacies
• By End Users: Adult patients with OUD, correctional facilities, outpatient clinics

The oral film formulations, offering ease of administration and improved patient compliance, are leading the segment.

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Market Drivers

Opioid Crisis and Regulatory Support

The escalating opioid epidemic has prompted governments to adopt aggressive treatment strategies. The U.S. government’s 2021 budget increased funding for opioid addiction treatment and expanded access to MAT, bolstering demand [3].

Rising Awareness and Acceptance

Enhanced understanding of OUD as a chronic disease, coupled with destigmatization efforts, has widened patient acceptance of pharmacotherapies. The approval and distribution of long-acting formulations further support adherence.

Policy and Reimbursement

Significant investments in healthcare infrastructure and Medicaid reimbursement policies favor access to buprenorphine/naloxone treatments.

Innovation and Pipeline Expansion

Pharmaceutical companies are investing in novel formulations—including transdermal patches and extended-release injectable versions—aimed at improving compliance and reducing diversion risk.

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Market Challenges

Regulatory Constraints and Practitioner Capitation

The Drug Addiction Treatment Act of 2000 (DATA 2000) limits prescribing to specially authorized physicians, which can restrict access.

Stigma and Public Perception

Despite increasing acceptance, stigma persists, affecting patient willingness and coverage decisions.

Generic Competition and Pricing Pressures

Patent expirations of leading brand formulations, coupled with the introduction of generics, exert downward pricing pressure.

Supply Chain Disruptions

Logistical challenges—especially during global crises such as the COVID-19 pandemic—have impacted production and distribution.

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Regulatory Landscape

Global Approvals and Guidelines

Most regulatory agencies, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), have approved buprenorphine/naloxone formulations for OUD. The Drug Enforcement Administration (DEA) classifies buprenorphine as a Schedule III controlled substance, influencing prescribing regulations.

Reimbursement Policies

In the U.S., public and private insurers increasingly reimburse for MAT, with Medicaid playing a key role.

Potential Legal and Licensing Barriers

Future regulatory actions, such as restrictions or expanded prescribing rights, could influence market dynamics.

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Competitive Landscape

Key Players

• Indivior (Suboxone)
• Alvogen (generic formulations)
• Mundipharma
• Sandoz (generic)

Indivior remains the market leader with a significant patent portfolio, although patent expirations have introduced robust generic competition.

Emerging Entrants and Pipeline Products

Companies are advancing formulations with longer duration, increased bioavailability, and abuse-deterrent features, broadening therapeutic options.

Strategic Collaborations

Partnerships between biotech firms, hospitals, and government agencies aim to expand access and innovate in delivery systems.

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Financial Trajectory

Revenue Trends

Leading companies have reported steady revenue growth, driven by expanding patient populations and global outreach. For example, Indivior reported USD 1.1 billion in annual sales of Suboxone pre-patent expiry, with a decline thereafter due to generic competition [4].

Impact of Patent Expirations

Patent cliff has resulted in sharp revenue declines for incumbent brand leaders; however, it has spurred growth for generic manufacturers, creating a competitive pricing environment.

Forecasted Revenue Growth

Projections estimate a CAGR of 8-10% over the next decade, driven by increasing global OUD treatment needs, expanding markets in Europe and Asia, and technological advances in drug delivery.

Pricing Dynamics

Prices are expected to decline due to generic entries, but improved formulations and formulations with abuse-deterrent features could command premium pricing in specific markets.

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Market Entry and Investment Opportunities

• Expansion into emerging markets with rising OUD prevalence.
• Development of innovative delivery systems, such as implants and long-acting injectables.
• Strategic acquisitions of generic manufacturing assets.
• Integration with digital health platforms to improve adherence monitoring.

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Impact of COVID-19

The pandemic accelerated adoption of telemedicine, enhancing access to OUD treatments, including buprenorphine/naloxone, especially in remote areas. Regulatory relaxations, such as allowing longer prescription durations via telehealth, are likely to sustain these gains.

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Future Outlook

The outlook for buprenorphine/naloxone remains optimistic, anchored by the unrelenting opioid crisis. Advancements in pharmacology, sustained regulatory support, and increased global adoption are projected to fuel growth. However, market participants must navigate patent expirations, pricing pressures, and evolving regulatory landscapes.

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Key Takeaways

• The global market for buprenorphine/naloxone is poised for steady growth, driven by rising opioid dependence and supportive policies.
• Patent expirations have introduced robust generic competition, compressing prices but expanding access.
• Investment in innovative formulations and delivery systems offers competitive advantages.
• Regulatory frameworks significantly influence prescribing practices and market penetration.
• Emerging markets and digital health integration present promising avenues for expansion.

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FAQs

1. How does regulatory policy affect the market for buprenorphine/naloxone?
Regulatory policies, including prescribing restrictions and approval processes, directly influence market access. Relaxations during the COVID-19 pandemic, such as telehealth prescribing allowances, have expanded treatment reach, potentially shaping future policies.

2. What is the impact of patent expirations on the profitability of leading brands?
Patent expirations typically lead to increased generic competition, reducing prices and market share for brand-name drugs. While revenue declines initially, companies may pivot to specialty formulations or pursue pipeline innovation.

3. Are there emerging formulations that could disrupt the current market?
Yes, long-acting injectable, implantable, and transdermal regimens are under development, promising better adherence and abuse deterrence, potentially reshaping competitive dynamics.

4. How significant is the role of global markets outside North America?
Expanding markets in Europe, Latin America, and Asia offer significant growth opportunities, particularly as opioid dependence awareness and treatment infrastructure improve.

5. What are the key challenges in expanding access to buprenorphine/naloxone treatment?
Crucial challenges include regulatory restrictions, stigma, limited healthcare provider training, and supply chain limitations, especially in underserved regions.

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References

[1] SAMHSA. (2022). Key Substance Use and Mental Health Indicators in the United States. Substance Abuse and Mental Health Services Administration.

[2] MarketWatch. (2022). Global Opioid Dependence Treatment Market Forecast.

[3] U.S. Department of Health & Human Services. (2021). FY2021 Budget Fact Sheet.

[4] Indivior. (2022). Annual Report.