BUPRENORPHINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for buprenorphine hydrochloride and what is the scope of patent protection?

Buprenorphine hydrochloride is the generic ingredient in ten branded drugs marketed by Bdsi, Reacx Pharms, Indivior, Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Sun Pharm, Alvogen, Difgen Pharms, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Ethypharm Usa Corp, Lannett Co Inc, Specgx Llc, Wes Pharma Inc, and Orexo Us Inc, and is included in forty NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine hydrochloride has seventy-six patent family members in twenty-seven countries.

There are sixteen drug master file entries for buprenorphine hydrochloride. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BUPRENORPHINE HYDROCHLORIDE

International Patents:	76
US Patents:	18
Tradenames:	10
Applicants:	27
NDAs:	40
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	535
Patent Applications:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPRENORPHINE HYDROCHLORIDE
What excipients (inactive ingredients) are in BUPRENORPHINE HYDROCHLORIDE?	BUPRENORPHINE HYDROCHLORIDE excipients list
DailyMed Link:	BUPRENORPHINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BUPRENORPHINE HYDROCHLORIDE

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

Sponsor	Phase
Montefiore Medical Center	PHASE3
Wake Forest University Health Sciences	PHASE4
Braeburn Inc	PHASE4

See all BUPRENORPHINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BUPRENORPHINE 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

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE HYDROCHLORIDE

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

Paragraph IV (Patent) Challenges for BUPRENORPHINE HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELBUCA	Buccal Film	buprenorphine hydrochloride	75 mcg and 150 mcg	207932	1	2016-10-24
BELBUCA	Buccal Film	buprenorphine hydrochloride	300 mcg, 450 mcg, 600 mcg and 750 mcg	207932	1	2016-10-04
BELBUCA	Buccal Film	buprenorphine hydrochloride	900 mcg	207932	1	2016-09-12

US Patents and Regulatory Information for BUPRENORPHINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	8,658,198		Y
Bdsi	BUNAVAIL	buprenorphine hydrochloride; naloxone hydrochloride	FILM;BUCCAL	205637-002	Jun 6, 2014		DISCN	Yes	No	8,147,866		Y
Ethypharm Usa Corp	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204431-001	Oct 16, 2015	AB	RX	No	No

Expired US Patents for BUPRENORPHINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-004	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-002	Oct 23, 2015	6,159,498
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-001	Oct 23, 2015	6,159,498

International Patents for BUPRENORPHINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Singapore	10201710667Y	TRANSMUCOSAL DRUG DELIVERY DEVICES FOR USE IN CHRONIC PAIN RELIEF
Ukraine	96455
New Zealand	574361	TRANSMUCOSAL DELIVERY DEVICES WITH ENHANCED UPTAKE CONTAINING BUPRENORPHINE

Market Dynamics and Financial Trajectory for Buprenorphine Hydrochloride

Last updated: November 21, 2025

Introduction

Buprenorphine hydrochloride, a semi-synthetic opioid partial agonist, has established itself as an essential therapeutic agent in managing opioid use disorder (OUD), chronic pain, and palliative care. Its unique pharmacological profile—combining analgesic efficacy with reduced abuse potential—has driven its adoption worldwide. Understanding the evolving market landscape and financial trajectories of buprenorphine hydrochloride is crucial for stakeholders ranging from pharmaceutical manufacturers to investors and healthcare policymakers.

Global Market Overview

The global buprenorphine hydrochloride market has experienced robust growth over the past decade, powered by escalating OUD prevalence, expanding pain management needs, and shifting regulatory environments. The GlobalData report estimates the market was valued at approximately USD 3.2 billion in 2022, with a compound annual growth rate (CAGR) of about 9.5% projected through 2028 [1].

This growth is attributable to increased awareness of opioid addiction and the adoption of buprenorphine as a first-line treatment, especially in developed countries like the U.S., Canada, and Western European nations, where regulatory barriers have eased to facilitate access.

Market Drivers

1. Rising Opioid Use Disorder (OUD) Prevalence

The opioid epidemic, notably in North America, has significantly increased demand for buprenorphine. The U.S. Centers for Disease Control and Prevention (CDC) reported over 100,000 overdose deaths in 2021, emphasizing the urgent need for effective treatment options [2].

2. Regulatory Reforms and Expanded Access

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA) have relaxed prescribing restrictions, enabling healthcare providers to initiate treatment with buprenorphine more freely. This shift has expanded its therapeutic scope, especially through initiatives like the comprehensive opioid use disorder treatment programs.

3. Adoption in Chronic Pain Management

Beyond OUD, buprenorphine's partial agonist profile offers an alternative to full opioids, reducing the risk of dependency and respiratory depression. This has propelled its use in chronic pain protocols, particularly in the context of the opioid stewardship movement.

4. Generic Market Penetration

The patent expiration of several brand-name formulations has fostered a surge in generic production, significantly reducing costs and increasing affordability—crucial for expanding access in low- and middle-income countries (LMICs).

Market Challenges

1. Regulatory and Legal Barriers

Despite reforms, some regions maintain strict regulations governing opioid prescribing, limiting the drug’s availability and market penetration.

2. Stigma and Public Perception

The association of buprenorphine with opioid addiction can deter patient willingness or provider prescribing, although educational initiatives are gradually mitigating this issue.

3. Supply Chain Complexities

Manufacturing complexities, supply chain disruptions, and regulatory compliance costs influence pricing and availability, especially for newer formulations or combination products.

Key Market Segments

1. Therapeutic Application

• Opioid Use Disorder Treatment: Dominates the market, comprising about 70% of sales.
• Chronic Pain Management: Growing segment owing to safer analgesic profiles.
• Palliative Care: Smaller but steady contribution due to its utility in end-stage management.

2. Dosage Forms

• Subcutaneous and Transdermal Formulations: Growing trend driven by improved patient compliance.
• Sublingual Films/Tablets: Most prevalent due to ease of use.
• Injectables: For hospital emergency use and addiction treatment programs.

3. Geography

• North America: Largest market share (~45%), driven by high OUD prevalence and regulatory support.
• Europe: Growing demand, especially in the UK, Germany, and France.
• Asia-Pacific: Fastest-growing due to expanding healthcare infrastructure and prevalence of opioid dependence in countries like India and China.
• Latin America and Africa: Emerging markets with increasing focus on harm reduction strategies.

Financial Trajectory

Revenue Projections

Forecasts suggest that the buprenorphine hydrochloride market will sustain a CAGR of approximately 9–10% through the next five years [1]. Revenue growth is primarily fuelled by increased prescriptions, new formulations, and expanding markets.

Pricing Trends

• Generic Competition: Continual price erosion for generic formulations is anticipated, pushing average prices down by 3–5% annually.
• Premium Formulations: Specialized delivery systems (e.g., transdermal patches) command higher margins but comprise a smaller share of overall revenue.

Investment and R&D

Pharmaceutical companies are investing heavily in developing abuse-deterrent formulations and combination products (e.g., buprenorphine with naloxone) to stay competitive and meet regulatory standards [3].

Competitive Landscape

Key players include:

• Teva Pharmaceutical Industries Ltd.
• Mylan N.V. (now part of Viatris Inc.)
• Boehringer Ingelheim
• Purdue Pharma (prior to discontinuation)
• Northera (a generic manufacturer)

These companies leverage patent expirations and strategic collaborations to expand their market footprint.

Emerging Trends

• Digital and Telemedicine Integration: Facilitates remote prescribing and monitoring, increasing access in underserved regions.
• Regulatory Approvals for New Indications: Expanding therapeutic uses potentially open new revenue streams.
• Formulation Innovation: Enhancing drug delivery, such as long-acting injectables and patches, to improve adherence and reduce misuse.

Market Outlook and Future Opportunities

The trajectory of buprenorphine hydrochloride remains optimistic, with growth prospects aligned to the global priorities of combating opioid addiction and optimizing pain management. Market expansion in LMICs and digital health integration represents significant opportunities. However, regulatory vigilance and public education are key to maximizing its potential.

Key Takeaways

• The global buprenorphine hydrochloride market is projected to grow at a CAGR of nearly 10% through 2028, driven chiefly by the opioid epidemic and expanded treatment access.
• Generic formulations will induce price competition but also enable broader access, especially in emerging markets.
• Regulatory reforms and innovative delivery systems will bolster demand, with long-acting formulations gaining prominence.
• Challenges include regulatory barriers, stigma, and supply chain complexities, which necessitate strategic mitigations for stakeholders.
• Investment in R&D for abuse-deterrent technologies and new therapeutic indications remains vital for sustained growth.

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FAQs

1. What factors are most influencing the growth of buprenorphine hydrochloride globally?
The primary drivers include increasing opioid addiction rates, regulatory liberalization enabling broader prescribing, and the development of generic, affordable formulations.

2. How does generic competition affect the market?
It significantly reduces prices, improves access, and stimulates market volume but constrains profit margins for manufacturers of branded products.

3. Are there recent innovations in buprenorphine formulation?
Yes, long-acting injectables, transdermal patches, and abuse-deterrent formulations are recent developments that enhance compliance and safety.

4. What regional differences impact market dynamics?
North America leads due to high OUD prevalence and supportive regulations; Asia-Pacific shows rapid growth due to expanding healthcare infrastructure; regulatory stringency varies globally.

5. What future trends could reshape the buprenorphine landscape?
Digital health integration, expanded indications, and novel delivery systems will likely influence future market trajectories.

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References

[1] GlobalData. "Buprenorphine Hydrochloride Market Analysis, 2023-2028."
[2] CDC. "Opioid Overdose Deaths." Centers for Disease Control and Prevention, 2022.
[3] MarketWatch. "Innovations in Opioid Pharmacotherapy," 2022.