BUPRENORPHINE - Generic Drug Details

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

Buprenorphine is the generic ingredient in fourteen branded drugs marketed by Amneal, Difgen Pharms, Mylan Tech Viatris, Strides Pharma Intl, Watson Labs Teva, Purdue Pharma Lp, Braeburn, Indivior, Bdsi, Reacx Pharms, Am Regent, Hikma, Hospira, Ph Health, Somerset Theraps Llc, Actavis Elizabeth, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Sun Pharm, Alvogen, 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-eight NDAs. There are thirty-nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Buprenorphine has one hundred and seventy-six patent family members in thirty-six countries.

There are twenty-nine drug master file entries for buprenorphine. Ten suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for BUPRENORPHINE

International Patents:	176
US Patents:	39
Tradenames:	14
Applicants:	33
NDAs:	48
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	535
Patent Applications:	4,853
Drug Prices:	Drug price trends for BUPRENORPHINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUPRENORPHINE
What excipients (inactive ingredients) are in BUPRENORPHINE?	BUPRENORPHINE excipients list
DailyMed Link:	BUPRENORPHINE at DailyMed

See drug prices for BUPRENORPHINE

Recent Clinical Trials for BUPRENORPHINE

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 clinical trials

Generic filers with tentative approvals for BUPRENORPHINE

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

Drug Class	Partial Opioid Agonist
Mechanism of Action	Partial Opioid Agonists

Medical Subject Heading (MeSH) Categories for BUPRENORPHINE

Analgesics, Opioid

Narcotic Antagonists

Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for BUPRENORPHINE

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

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
Sun Pharm	BUPRENORPHINE HYDROCHLORIDE	buprenorphine hydrochloride	TABLET;SUBLINGUAL	201760-002	Jan 29, 2016	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No
Mylan Tech Viatris	BUPRENORPHINE	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	210162-002	May 3, 2021		DISCN	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No			Y
Rhodes Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205601-002	Mar 30, 2020	AB	RX	No	No
Amneal Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	203136-001	Feb 22, 2013	AB	RX	No	No

Expired US Patents for BUPRENORPHINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010

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/004743Sixmo 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/004651Treatment 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

International Patents for BUPRENORPHINE

Country	Patent Number	Title	Estimated Expiration
Mexico	PA06014095
Denmark	3360538
China	103079544	Injectable flowable composition comprising buprenorphine
Mexico	361873	FORMULACIONES DE OPIOIDES. (OPIOID FORMULATIONS.)
South Korea	20070046815
Spain	2458992

Market Dynamics and Financial Trajectory for Buprenorphine

Last updated: July 27, 2025

Introduction

Buprenorphine, a partial opioid agonist, has become central to managing opioid use disorder (OUD) and acute pain. Its dual functionality, combined with the global surge in opioid addiction and the need for effective treatment options, positions buprenorphine as a pivotal therapeutic agent. This article dissects the market dynamics influencing buprenorphine, explores its financial trajectory, and analyzes factors shaping its future.

Market Overview

The global buprenorphine market has experienced exponential growth driven by escalating opioid crises, evolving regulatory landscapes, and advances in drug delivery systems. As of 2023, the market is projected to amplify at a compound annual growth rate (CAGR) of approximately 6.2% over the next five years, reaching over $4 billion by 2028 (1).

Key segments include:

• Formulations: Sublingual tablets, films, implants, transdermal patches, and injectable forms.
• Indications: OUD management, pain relief, and off-label uses.

The United States commands the largest share, attributable to aggressive opioid epidemic management initiatives, increased insurance coverage, and widespread adoption of buprenorphine-based treatments.

Drivers of Market Growth

1. Rising Opioid Crisis and Regulatory Support

The opioid epidemic in North America remains a primary catalyst. With over 100,000 drug overdose deaths annually in the US alone, authorities endorse buprenorphine as a critical component for treatment. The Drug Addiction Treatment Act (DATA 2000) and subsequent legislation have eased prescribing restrictions, facilitating wider access.

2. Expanding Treatment Paradigms

Healthcare providers increasingly favor buprenorphine over methadone due to its safety profile, lower overdose risk, and outpatient applicability. The development of flexible formulations, such as long-acting implants (e.g., Probuphine by Indivior), supports adherence and reduces abuse potential.

3. Increasing Focus on Pain Management

Beyond OUD, buprenorphine’s analgesic properties open avenues in pain management, especially for chronic and post-operative pain, expanding its application scope.

4. Accelerated Approvals and Pipeline Innovations

Pharmaceutical companies are investing in novel delivery mechanisms—such as transdermal patches and injectable depot forms—that target improved patient compliance and reduce diversion risk.

5. Societal and Economic Imperatives

Growing recognition of addiction as a medical condition fosters funding, insurance reimbursement, and public health campaigns that boost buprenorphine penetration.

Challenges and Market Restraints

1. Regulatory and Licensing Barriers

Despite relaxations, prescribing buprenorphine still requires waivers in some jurisdictions, hampering widespread adoption. Stringent controls are particularly influential in emerging markets.

2. Stigma and Misconceptions

Stigma surrounding addiction and concerns about diversion limit provider willingness to prescribe buprenorphine. Education and policy reforms remain critical.

3. Patent Cliff and Generic Competition

Many innovator formulations are nearing patent expiration, increasing generic availability, which intensifies price competition but also affects margins for original manufacturers.

4. Side Effects and Safety Concerns

Risks such as respiratory depression, dependence, and precipitated withdrawal may influence prescriber and patient acceptance, though these are generally manageable.

Market Players and Competitive Landscape

Major players include:

• Indivior Plc: Pioneers in sublingual formulations and long-acting implants.
• Mundipharma: Commercializing formulations for pain and OUD.
• Teva Pharmaceutical: Engaged in generic buprenorphine products.
• Lundbeck: Focused on nasal spray and innovative delivery systems.

New entrants and biotech startups are innovating in depots, smart delivery devices, and combination therapies, driving market diversification.

Financial Trajectory

Revenue Trends

The buprenorphine market has demonstrated resilient revenue growth, fueled by increased prescribing volumes, expanding indications, and price adjustments. In 2022, global revenues topped $3.2 billion, with the US accounting for approximately 75% of sales (1).

Pricing Dynamics

Pricing varies significantly across formulations. Sublingual tablets typically retail between $10–$20 per dose, while long-acting implants can cost upwards of $1,000 per month but offset compliance costs. Price reductions owing to generics are expected to make treatments more accessible but may compress profit margins.

Profitability Outlook

Original brand-name formulations maintain higher margins due to patent protections and value-added features. As patents lapse, generic firms will drive down prices, encouraging broader adoption but pressuring revenues for innovator firms.

Forecasting Trends

Projections suggest a steady upward trajectory in revenues driven by:

• Broadened insurance coverage.
• Introduction of cost-effective generic alternatives.
• Increased use in pain management protocols.
• Adoption in emerging markets with high unmet needs.

However, regional regulatory hurdles and societal barriers could temper growth in specific geographies.

Future Outlook and Innovation

The future of buprenorphine hinges on technological innovation, regulatory reforms, and societal acceptance. Expected breakthroughs include:

• Long-acting formulations: Extended-release implants and injectables offering months of sustained therapy.
• Combination therapies: Multi-modal drugs integrating buprenorphine with naloxone or other agents.
• Digital health integration: Telemedicine-compatible prescribing and adherence monitoring platforms.

These innovations aim to enhance treatment adherence, reduce diversion, and expand market reach.

Conclusion

Buprenorphine stands at the nexus of pharmaceutical innovation, public health policy, and societal change. Its evolving market, driven by unmet medical needs, regulatory support, and technological advancement, forecasts robust growth over the coming years. Nevertheless, overcoming barriers related to stigma, regulation, and competition remains essential to fully realize its market potential.

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Key Takeaways

• The buprenorphine market is projected to grow at a CAGR of approximately 6.2% through 2028, reaching over $4 billion globally.
• Rising opioid addiction crises and supportive regulatory shifts are primary market drivers.
• Innovations in delivery systems and expanding indications in chronic pain management will further enhance revenue streams.
• Patent expirations and increased generic competition will impact pricing strategies but broaden access.
• The integration of digital health tools and long-acting formulations will define the future landscape, improving adherence and reducing diversion.

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FAQs

Q1: How has regulatory reform influenced buprenorphine's market expansion?
Regulatory initiatives, such as the US’s DATA 2000 waiver program, have simplified prescribing procedures, enabling more healthcare providers to prescribe buprenorphine for OUD. These reforms have expanded access, bolstered treatment numbers, and contributed significantly to market growth.

Q2: What are the primary formulations of buprenorphine, and how do they differ?
Available formulations include sublingual tablets and films, buccal films, transdermal patches, long-acting implants, and injectable depots. Long-acting formulations provide extended drug release, improve adherence, and reduce diversion risk compared to daily dosing forms.

Q3: What challenges does the market face regarding generic competition?
As patents expire, generic manufacturers enter the market, decreasing prices and profit margins for brand leaders. While increasing accessibility, this competition necessitates innovation to maintain market share and profitability for original developers.

Q4: How significant is buprenorphine's role in pain management?
Beyond OUD, buprenorphine’s analgesic properties make it valuable for managing chronic and post-operative pain, diversifying its therapeutic applications and contributing to market diversification.

Q5: What technological innovations are expected to shape buprenorphine's future?
Long-acting implants, injectable depots, combination therapies, and digital adherence tools will revolutionize treatment modalities, improve patient compliance, and mitigate abuse and diversion concerns.

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References
[1] Market Research Future, "Buprenorphine Market Analysis," 2023.