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, Ascent Pharms Inc, Barr, Ethypharm, Pharmobedient, Rhodes Pharms, Rubicon Research, Specgx Llc, Sun Pharm, Alvogen, Dr Reddys Labs Sa, Mylan Technologies, Teva Pharms Usa, Alkem Labs Ltd, Amneal Pharms, Lannett Co Inc, Wes Pharma Inc, and Edenbridge Pharms, and is included in fifty-two NDAs. There are thirty-eight 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:	38
Tradenames:	14
Applicants:	33
NDAs:	52
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	537
Patent Applications:	4,783
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
Atea Pharmaceuticals, Inc.	PHASE1
Wake Forest University Health Sciences	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
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-003	Dec 11, 2014		RX	Yes	No	11,433,066
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	10,874,661		Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-002	May 23, 2023		RX	Yes	No	8,236,755		Y
Edenbridge Pharms	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-002	Jul 3, 2013		RX	Yes	No	8,470,361		Y
Bdsi	BELBUCA	buprenorphine hydrochloride	FILM;BUCCAL	207932-003	Oct 23, 2015		RX	Yes	No	8,147,866		Y

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	5,240,711
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-002	Jun 30, 2010	RE41489
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-006	May 23, 2023	8,545,832
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	6,344,211
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	9,642,850

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
Portugal	2877155
European Patent Office	2206495	Formulations bioadhésives topiques (Topical bioadhesive formulations)
European Patent Office	1848403	FORMULATIONS BIOADHESIVES TOPIQUES (TOPICAL BIOADHESIVE FORMULATIONS)
Poland	1768650
Russian Federation	2012157244	ЖИДКОТЕКУЧИЕ КОМПОЗИЦИИ ДЛЯ ИНЪЕКЦИЙ, ВКЛЮЧАЮЩИЕ БУПРЕНОРФИН

Market Dynamics and Financial Trajectory for Buprenorphine

Last updated: February 20, 2026

What Is Buprenorphine and Its Market Significance?

Buprenorphine is a semi-synthetic opioid used primarily for opioid dependence treatment and pain management. It acts as a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Its unique pharmacology reduces the risk of misuse, respiratory depression, and overdose compared to full agonists like morphine or heroin.

In 2022, the global buprenorphine market was valued at approximately USD 4.5 billion. Growth is driven by rising opioid dependence, expands in pain management, and shifts toward abuse-deterrent formulations.

What Are Key Market Drivers?

Rising Opioid Use Disorder Incidence

An increase in opioid misuse, particularly in North America, has escalated demand for buprenorphine-based treatments. The U.S. accounts for roughly 50% of global sales, with an opioid epidemic contributing to this trend. The National Institute on Drug Abuse reported over 2 million Americans with opioid use disorder in 2021, fueling market expansion.

Regulatory Support and Policy Changes

The FDA allows office-based prescribing of buprenorphine, increasing accessibility. The Drug Addiction Treatment Act (DATA) of 2000 permits qualified physicians to prescribe buprenorphine outside clinics. Recent policy relaxations, especially during COVID-19, have removed some prescribing barriers.

Expansion in Pain Management and Off-label Use

Buprenorphine's analgesic properties prompt its off-label use for chronic pain. The approval of formulations like Buvidal (buprenorphine subcutaneous depot) offers new options for pain management, broadening the market.

Introduction of Abuse-Deterrent Formulations

Companies like Indivior and Teva developed abuse-deterrent formulations (ADFs). These reduce intravenous misuse potential, addressing regulatory and safety concerns. ADFs generally command premium pricing, boosting revenue.

What Are Market Challenges?

Regulatory and Legal Barriers

Despite relaxed rules, some countries maintain strict controls on opioid distribution. The potential for misuse, diversion, and regulatory scrutiny pose risks.

Competition from Alternative Therapies

Other medications for opioid dependence, like methadone and naltrexone, compete with buprenorphine. The market shares of these therapies fluctuate based on regulatory approvals and prescriber preferences.

Patent Expirations and Generic Entry

Several key formulations face patent cliffs, leading to increased generics. For example, Teva’s Suboxone (combo of buprenorphine and naloxone) patents expired in 2022, causing price erosion and margin compression.

Pricing Pressures and Reimbursement Policies

Insurance coverage, government reimbursement rates, and pharmacy benefit managers influence market profitability. Governments may implement price controls.

How Does the Financial Trajectory Look?

Revenue Growth Patterns

Projections indicate a compound annual growth rate (CAGR) of approximately 7.5% for the global buprenorphine market from 2022 to 2028. This growth is driven by expanding indications and geographic spread.

Year	Market Value (USD billion)	Growth Rate (%)
2022	4.5	-
2023	4.84	7.5
2024	5.19	7.3
2025	5.57	7.4
2026	5.97	7.2
2027	6.41	7.4
2028	6.88	7.4

Revenue Segmentation

The largest revenue contributor remains opioid dependence treatment, accounting for roughly 65% of total sales in 2022. Pain management formulations occupy the remaining share, with growth driven by new depot and transdermal products.

Key Companies and Market Shares

Company	Estimated 2022 Market Share (%)	Key Products
Indivior	45	Suboxone, Sublocade
Teva	20	BUPRENEX, SUBUTEX
Camurus	15	Buvidal
Others	20	Multiple generics

Patent expirations, notably of Suboxone’s core patents, have increased generic availability, impacting brand revenues.

Investment and R&D Outlook

Major players invested an estimated USD 150 million in R&D in 2022, focusing on formulations with abuse-deterrent features, long-acting injectables, and formulations targeting chronic pain. Investment is expected to grow with the expanding market.

What Are the Future Opportunities?

• Long-acting formulations: Depot injections and transdermal patches offer adherence benefits and reduced diversion risks.
• Global expansion: Developing markets exhibit rising opioid misuse, offering growth avenues.
• Combination therapies: Developing synergistic formulations integrating buprenorphine with other agents.
• Digital health integration: Telemedicine approvals expand access and adherence.

What Risks Could Impair Market Growth?

• Stringent regulations and diversion controls may restrict prescribing.
• Pharmacovigilance concerns could lead to market withdrawal of certain formulations.
• Competitive displacement by novel drugs or non-opioid therapies may reduce market share.

Key Takeaways

• The global buprenorphine market will grow at ~7.5% CAGR through 2028.
• Opioid dependence treatment remains the primary driver, with expanding pain management indications.
• Patent expirations and generic entry pressure profits, but newer formulations and expanded indications offset these impacts.
• Regulatory and reimbursement policies significantly influence market dynamics.
• Investment focus shifts toward long-acting, abuse-deterrent products, and global expansion.

FAQs

1. What is the main use of buprenorphine in clinical practice? It treats opioid use disorder and provides pain relief with lower misuse potential.

2. Who are the leading pharmaceutical companies in the buprenorphine market? Indivior, Teva, and Camurus dominate, with newer entrants expanding options.

3. How does patent expiration affect market revenues? It leads to increased generic competition, reducing prices and margins for brand-name drugs.

4. What role do regulatory policies play in market growth? They facilitate access through relaxed prescribing rules, but also impose restrictions to curb diversion.

5. What new formulations are expected to influence future market trends? Long-acting injectables, transdermal patches, and abuse-deterrent formulations are upcoming products.

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References

[1] National Institute on Drug Abuse. (2021). Opioid statistics. https://www.drugabuse.gov/publications/drugfacts/opioids

[2] MarketsandMarkets. (2023). Buprenorphine market forecast and trends. https://www.marketsandmarkets.com/Market-Reports/buprenorphine-market-251963018.html

[3] U.S. Food and Drug Administration. (2021). Approval summaries for buprenorphine formulations. https://www.fda.gov

[4] Indivior. (2022). Annual report. https://www.indivior.com/financial-reports

[5] Teva Pharmaceuticals. (2022). Investor presentation. https://www.tevapharm.com