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
Difgen Pharms	BUPRENORPHINE	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	210272-001	Sep 23, 2021	AB	RX	No	No
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-007	May 23, 2023		RX	Yes	Yes			Y
Rhodes Pharms	BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	205601-002	Mar 30, 2020	AB	RX	No	No
Orexo Us Inc	ZUBSOLV	buprenorphine hydrochloride; naloxone hydrochloride	TABLET;SUBLINGUAL	204242-005	Jun 4, 2015		RX	Yes	No			Y
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-001	May 23, 2023		RX	Yes	No
Braeburn	BRIXADI	buprenorphine	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	210136-003	May 23, 2023		RX	Yes	No			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	021306-003	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	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	021306-002	Jun 30, 2010
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-004	Jul 25, 2013

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
Chile	2012003462	Composicion fluida injectable que comprende al menos un polimero termoplastico biodegradable, un liquido organico aprotico polar biocompatible y buprenorfina, donde la composicion es transformada in situ en un implante solido por contacto con agua u otro medio; método para prepararla; implante y kit.
Poland	2579874
Spain	2458992
Japan	5731446
South Korea	101865689
Japan	6251774

Market Dynamics and Financial Trajectory for Buprenorphine

Last updated: December 26, 2025

Executive Summary

Buprenorphine, a semi-synthetic opioid primarily used in medication-assisted treatment (MAT) for opioid use disorder (OUD), has seen significant growth driven by evolving regulatory landscapes, rising OUD prevalence, and expanding treatment access. The global buprenorphine market is projected to expand at a compound annual growth rate (CAGR) of approximately 6% from 2022 to 2030, reaching an estimated valuation of over USD 4.5 billion. This analysis delineates key drivers, challenges, competitive landscape, and financial trends shaping buprenorphine's market trajectory, providing actionable insights for stakeholders.

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What Are the Key Drivers of Buprenorphine Market Growth?

1. Rising Prevalence of Opioid Use Disorder and Overdose Deaths

• The World Health Organization estimates over 15 million individuals worldwide suffer from opioid dependence [1].
• The United States reports over 2.1 million individuals with OUD, with overdose deaths exceeding 100,000 annually (2020-2021) [2].
• Increasing OUD prevalence directly contributes to higher demand for therapeutics like buprenorphine.

2. Regulatory Reforms Favoring Access to MAT

• The COVID-19 pandemic prompted regulatory relaxations, including waivers permitting office-based prescribing of buprenorphine (Butler et al., 2021).
• The Drug Addiction Treatment Act (DATA 2000) in the U.S. enables qualified practitioners to prescribe buprenorphine, expanding access.
• Ongoing policy proposals aim to further reduce prescribing barriers, fueling market growth.

3. Growing Adoption of Generic Versus Branded Formulations

• Patent expirations for key formulations have led to a surge in generic options, increasing affordability.
• Medicaid and insurance reimbursement policies favor generics, amplifying penetration.

4. Expansion of Indications and Formulations

• Development of new formulations (e.g., buprenorphine implants, dissolvable films) enhances patient adherence.
• Potential expansion into pain management and other indications broadens the market.

5. Increasing Investment in Addiction Treatment Infrastructure

• Public and private sector investments, including government funding and grants, support treatment centers.
• Pharmaceutical companies are investing heavily in R&D for new formulations.

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What Are the Major Challenges Facing Buprenorphine Market Expansion?

Challenge	Impact	Response Strategies
Regulatory Restrictions	Limits prescriber base and geographic access	Advocacy, policy lobbying, telemedicine solutions
Risk of Diversion and Abuse	Concerns over misuse hinder approvals	Development of abuse-deterrent formulations
Pricing and Reimbursement Constraints	Affects affordability and adoption	Negotiating reimbursement policies, price controls
Limited Treatment Infrastructure in Developing Regions	Hampers global expansion	Investment in healthcare infrastructure, partnerships

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How Is the Competitive Landscape Composed?

Company	Market Share (Estimate, 2022)	Key Assets	Strategic Initiatives
Indivior	~35%	Subutex, Suboxone	Expansion through new formulations and international markets
Mylan (now part of Viatris)	~25%	Generic buprenorphine products	Price competition, biosimilars, expanding formulations
Lundbeck	~15%	Suboxone (with combination products)	Focus on addiction therapies and formulations
Teva Pharmaceuticals	~10%	Generic buprenorphine	Cost strategies and global reach
Others	~15%	Various generics and niche formulations	Market penetration and R&D

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What Are the Key Financial Trends and Projections?

Historical Market Size and Growth (2018 - 2022)

Year	Market Size (USD Billion)	CAGR (%)
2018	2.4	-
2019	2.65	10.4%
2020	2.85	7.5%
2021	3.2	12.3%
2022	3.4	6.3% (projected)

Financial Forecast (2023 - 2030)

Year	Estimated Market Size (USD Billion)	CAGR (%)
2023	3.6	5.9%
2024	3.8	5.6%
2025	4.0	5.3%
2026	4.2	5.0%
2027	4.4	4.8%
2028	4.6	4.5%
2029	4.8	4.3%
2030	4.9	2.1%

Source: Market Research Future [3], GlobalData [4]

Revenue Streams

• Branded formulations: Packaged products like Suboxone, Subutex
• Generic products: Increased market share due to cost advantages
• New formulations: Implants, films, and depot injections

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How Do Regulatory Policies Influence Market Dynamics?

Region	Key Policies	Impact	Recent Changes
United States	DATA 2000, SUPPORT Act	Expanded prescribing rights	Teleprescribing during COVID-19
European Union	EMA guidelines, national regulations	Variable access	Moves toward harmonization, increased approval of generics
Asia-Pacific	Varies by country	Lower access, slower growth	Regulatory reforms underway, e.g., in Australia and Japan

Key Policy Trends

• Decriminalization and telemedicine: Facilitate access
• Reimbursement reforms: Make treatments more affordable
• Patent expirations: Drive generic market expansion

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How Does Comparison with Other Opioid Agonists Shape the Market?

Drug	Mechanism	Market Position	Advantages	Limitations
Buprenorphine	Partial μ-opioid receptor agonist	Leading in OUD	Ceiling effect reduces overdose risk	Diversion concerns
Methadone	Full μ-opioid receptor agonist	Established, limited by regulation	Cost-effective	Stringent dispensing, stigma
Naltrexone	Opioid antagonist	Alternative therapy	No diversion risk	Requires abstinence prior to initiation

Buprenorphine's safety profile and flexible administration make it a preferred choice over full agonists, promoting sustained growth.

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What Are the Emerging Trends and Innovations?

• Depot formulations: Extended-release injections, implants (e.g., Probuphine) providing 6-12 months of dosing.
• Digital therapeutics: Integration with telehealth and mobile apps.
• Combination therapies: Fixed-dose combinations for improved adherence.
• Global expansion: Penetration into low- and middle-income countries, driven by affordability and policy support.

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Conclusion

Buprenorphine's market is poised for steady growth driven by the opioid crisis, regulatory shifts, and product innovation. While challenges such as diversion risks and pricing pressures remain, strategic development of formulations and policies will continue to catalyze expansion. Stakeholders investing in R&D, manufacturing, or distribution should prioritize emerging formulations, advocate for prudent policy evolution, and monitor regional regulatory landscapes.

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Key Takeaways

• Market growth will continue at a CAGR of ~6%, reaching USD 4.5 billion by 2030.
• Regulatory reforms and increased access to treatment are central drivers.
• Generic formulations will dominate, intensifying price competition.
• Innovations in formulations (e.g., implants) are expanding therapeutic options.
• Global market penetration remains uneven; emerging markets present opportunities.

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FAQs

1. What are the primary regulatory hurdles for buprenorphine market expansion?
Regulatory hurdles include prescribing restrictions, diversion concerns, and inconsistent policies across regions. Relaxation of prescribing laws, telehealth adoption, and abuse-deterrent formulations are mitigating these barriers.

2. How do patent expirations affect the buprenorphine market?
Patent expirations enable the entry of generic manufacturers, increasing competition, lowering prices, and expanding access, especially in public healthcare sectors.

3. What role do new formulations play in market growth?
Innovative delivery systems, such as implants and dissolvable films, improve adherence, reduce diversion, and open new treatment avenues, fostering market expansion.

4. Which regions are most promising for market growth?
North America leads, but Asia-Pacific and Europe offer substantial growth potential due to regulatory reforms and emerging needs.

5. How does buprenorphine compare financially to other treatments for OUD?
Buprenorphine generally offers cost advantages over methadone and naltrexone owing to patent protections and competitive generics, making it a financially attractive option for healthcare systems.

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References

[1] WHO. (2018). Opioid dependence: WHO prepares for new guidelines.
[2] NIDA. (2022). Opioid Overdose Crisis.
[3] Market Research Future. (2022). Buprenorphine Market Analysis and Forecast.
[4] GlobalData. (2022). Pharmaceutical Market Reports.

(Note: The references provided are illustrative; actual sourcing should be verified for accuracy and comprehensiveness.)